Is Dendreon a $360 Stock - Or Is That Too Low? 100 comments
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Since Dendreon's (DNDN) conference call on April 13 to announce that the Provenge Phase III IMPACT clinical trial easily met its primary endpoint of a 22% reduction in deaths versus the placebo group, there have been numerous posts, articles and message board flames on both sides about what happens next. Not one of the seven analysts who published a rating on Dendreon's stock recommended buying it ahead of the release of the positive results, and not one has raised their rating to buy since the conference call.
That's remarkable, not just because this is the first cancer vaccine that will be approved by the FDA, but because Provenge works the way an effective cancer drug should work with no significant side effects. Just in the small group for which it was approved, it is likely to be a $1.5 billion drug in the U.S. alone, as I will show in the model below.
My valuation model explained below shows $1.5 billion dollars in Provenge revenue should equate to about $30 a share for DNDN stock today. Considering the potential for immediate off-label use in earlier stages of prostate cancer, I think there is another $1.5 billion in revenues in the U.S. alone. If the day comes that a doctor says: “Well, would you rather be castrated or try Provenge,” which would you choose? And for all those men currently dealing with prostate cancer by “watchful waiting,” how many might be interested in boosting their immune system to fight the illness? It's not hard to see how the U.S. market for Provenge in prostate cancer, on- and off-label, will hit $3 billion. That gets DNDN's current value up to $60.
In the next several months, probably sooner than later, Dendreon will sign a marketing agreement for European and possibly Japanese sales of Provenge. The rest-of-world market for most drugs is roughly equal to the U.S. market, so that adds another $3 billion in Provenge sales. One can argue that Dendreon will have to share the benefit of these sales, which is true, but one also can argue that they will avoid all the costs, which also is true. Until we know for sure what the royalty rate is, or whether this will be a joint venture with Dendreon providing amplified cells to a marketing partner, it is not possible to be more precise. On balance, until we get more information I am going to assume that a dollar of overseas Provenge sales is, one way or another, as good as a dollar of domestic sales, so this additional $3 billion in Provenge sales gets DNDN up to $120 in a couple of years if the U.S. data are acceptable for approval overseas.
Two years ago, when the FDA overruled the Biologics Advisory Committee and declined to approve Provenge, the company stopped early stage trials of the exact same technology platform in breast cancer and head & neck cancer. With the cash coming in from the forthcoming marketing partnership, those trials can be restarted. On the recent conference call, management said:
As you know, Provenge employs our novel proprietary Antigen Delivery Cassette technology that may be leveraged to develop similar products to treat breast, colon, bladder, kidney, and multiple other types of cancer. The IMPACT results renew and validate our confidence in this platform technology and our ability to extend its benefits across other cancer types. We will be evaluating a more comprehensive development plan to expand our cancer immunotherapy product pipeline.
Breast cancer can be a label expansion study, which may require a Phase II study with several dosage arms and a two-year Phase III survival study in the sickest patients, plus another year for FDA approval. The breast cancer market alone is at least as large as prostate cancer, so counting eventual approval and use on- and off-label in the U.S. and the rest of the world, that's another $6 billion in revenues. That gets DNDN up to $240 a share in about five years.
At the same time, given the financial resources likely to be available to the company without any shareholder dilution, other label expansion studies for “colon, bladder, kidney, and multiple other types of cancer” can be underway during the same five years. The markets for all of these put together are at least as large as for breast cancer or prostate cancer, so that's another $6 billion in revenues worldwide and another $120 a share on DNDN stock, getting it up to $360 a share in seven or eight years.
But that's not all. Dendreon had to do their Provenge trials in the sickest patients for ethical reasons. They can now move back the disease progression chain, creating earlier-stage prostate cancer trials for men who might not want to be castrated, or undergo procedures that will leave them impotent and incontinent for the rest of their lives. The main reason to expect these trials to succeed is this:
Provenge is the right way to treat cancer.
Cancer is an indication of underlying immune system weakness, just as a fever is an indication of an underlying infection. Treating only the tumor is like treating only the fever; it does not resolve the underlying problem. No less an authority than the American Cancer Society said as far back as 1975 that people with strong immune systems do not get cancer. That is because everyone has cancerous cells circulating in their body at all times, and one function of the immune system is to find them, kill them, and escort the dead cell out of the body. Our primary current methods of treating cancer are surgery, which always releases some escaping cells into the body, and chemotherapy and radiation, both of which substantially depress the immune system. Chemotherapy may kill 99% of a tumor, but the 1% it does not kill are the cancer cells that were drug-resistant. So if the cancer returns, it will be in the form of drug-resistant cells. That is why current cancer protocols have an abysmal record of curing recurrent cancer.
Provenge, on the other hand, takes a patient's specific prostate cancer cells, attached an antigen to “teach” the immune system what a bad cell looks like, and reinfuses the altered cells. The resulting very strong immune response triggered by the antigen naturally causes flu-like symptoms – headache, fever, chills – that are typical of the immune system at work. Those are the limited side effects of Provenge, a remarkably safe profile.
Remaining Issues
Why have the seven analysts on the sidelines not made Dendreon an aggressive buy? Some investors think at least some of the analysts are in bed with the shortsellers, but I think by their comments they simply don't understand the approval process from here.
At least one analyst said he wants to wait for the April 28 data presentation at the annual meeting of the American Urological Association before he believes it. Recall that there is only one data point under the Special Protocol Assessment for the IMPACT trial: Did Provenge reduce the number of deaths by 22% compared to the placebo? In the press release announcing the results, management said:
The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study's design.
On the conference call they said: “The results are unambiguous in nature. It was a clear hit on a pre-specified primary endpoint of overall survival.”
It seems unlikely to me that the data presentation on April 28 will show Provenge did not meet the 22% goal – their next call would be from the SEC. In light of words like”unambiguous” and “clear hit,” one wonders exactly what additional data this analyst needs to see. I believe the results could be stunning, on the order of a 25% to 28% reduction in deaths. Remember that in the trials presented to the FDA in 2007, 34% of the men who received Provenge were still alive after three years. That compared with only 11% of those in the placebo arm – the highest survival benefit ever seen in a trial for hormone-refractory prostate cancer patients. Doctor Paul Schellhammer, Program Director of the Virginia Prostate Center and Professor of Urology at Eastern Virginia Medical School, will give us the number during the Late-Breaking Science Forum at the April 28 AUA meeting, around 2:20 PM CDT.
I have also seen comments that the current valuation of Dendreon is ridiculous, because who knows if the FDA is going to approve the drug? Wrong. This trial was done under a Special Protocol Assessment – you hit your numbers, you get approval. There will not be another Advisory Committee meeting. There will be no interference, lobbying or letter-writing campaigns this time from the Oncology Division of the FDA.
It is true that in 1996 Dendreon management decided to advance Provenge through the Biologics Division of the FDA, so they went to the Biologics Advisory Committee for approval and got it. The Oncology Division is run by a long-time, rigid bureaucrat who believes Dendreon is going around him, and if he lets Provenge be approved, other cancer-treating biologics will go through the Biologics Division instead of the Oncology Division. It is all about bureaucratic turf wars. He was the one who sabotaged FDA approval in May, 2007, even after the Advisory Committee recommended approval. Even the last head of the FDA, himself a prostate cancer survivor, could not overpower this guy. Provenge has very minor side effects, but because the FDA turned the drug down, many men died needlessly in the last two years. Someone will write a book someday about this shameful blot on the FDA's reputation. It's disgusting, but many years ago the head of Genentech (DNA) told me: “This business is not about developing effective drugs, it is about getting drugs through the FDA.”
One of the key factors in Dendreon's favor that the negative and neutral analysts have not understood is that the company is organized to get their drug through the FDA. For the 1997 filing, they contracted with several ex-FDA reviewers to hammer on the data, the presentation, and anything else they could find that might bother the FDA. This time, they are taking until the fourth quarter to get the data polished up for their Type 2 resubmission. (Not a new BLA or Biologics License application – another error I've seen recently by the negative commentators. Dendreon filed their BLA in late 1996.)
In response to one analyst's disappointment on the conference call that they would not file sooner, management said:
This is a study that enrolled 500 men with metastatic advanced prostate cancer. It’s been going on now for almost six years. So there’s a tremendous amount of data for us to compile and include in this application. One of important things to remember about IMPACT, this is a landmark study, not just because it’s the first cancer immunotherapy to show a survival benefit. This is probably the longest follow-up that we’ve ever seen in a randomized Phase 3 clinical trial of men with advanced prostate cancer. So it’s very meaningful in terms of how this disease population behaves. It’s very important that we put together a high-quality amendment to the FDA, and we’re committed to doing that by the fourth quarter of this year.
Modeling Dendreon
A tip of the hat to Adam Feuerstein of TheStreet.com, who first published his Dendreon model over two years ago. I have modified it here, updating the underlying numbers on prostate cancer and raising the likely price for Provenge based on Dendreon management's comments on the conference call.
click to enlarge
The first row shows the new cases of prostate cancer each year, starting with American Cancer Society current statistics and increasing that by 1.5% per year to account for the aging baby boomers. I also could have modeled this using annual deaths from prostate cancer and assuming a much higher penetration rate and faster ramp for Provenge, but the numbers come out only a little lower.
So the first row shows the incidence of prostate cancer. But prostate cancer is a multiyear illness, and the prevalence of a disease is the total number of patients at any one time. Obviously, the prevalence numbers for prostate cancer are much higher than these incidence numbers, so this is a very conservative estimate of the potential market for Provenge.
The second row shows the percentage of patients that have hormone-refractory, metastatic cancer, which is what Provenge will be approved for. “Hormone-refractory” means hormone treatments are no longer controlling it, and “metastatic” means it has spread beyond the prostate. About 35% of prostate cancer patients have hormone-refractory, metastatic cancer, so that is row two. Row three is simply row two times 35%.
Row four is an estimate the percentage of patients willing to try Provenge. About 65% of all these patients today are willing to try chemotherapy, the dreaded Taxotere that has numerous nasty side effects. The other 35% chose not to move on. I estimate that most of those will gladly try Provenge, and around half of those who go on to Taxotere today will be willing to give Provenge a try first. Again, I think those are very conservative estimates, considering the relatively small benefit and miserable side effects of Taxotere. But I have assumed that at least 65% of these patents would try Provenge rather than do nothing or take Taxotere.
So row five is row three times 65%. Row six is the percentage of Provenge penetration. About 50% of the patients were treated by urologists and about 50% by oncologists. Dendreon management says a sales force of 100 will cover the market, but it takes time to build and train a sales force, have them make calls, get the doctors' attention and make sales. Of course, the whole prostate cancer community has been watching this drama, and my initial penetration estimates could be low. I have assumed Provenge gets FDA approval in mid-2010, although I actually think Dendreon will file the Type 2 resubmittal in October and get approval in April 2010. So the penetration rate in 2010 is only 5%, rising to 10% in 2011. I maxed it out at 60% in the fifth year, although many mature drugs are closer to 80%. Again, I am trying to make a conservative estimate for this patient population.
Row seven is the penetration rate times the possible number who would choose Provenge. Row eight is my estimate of the cost of Provenge treatment, three infusions over six weeks. Leading cancer treatments today cost around $50,000 and are fully reimbursed by Medicare and the HMOs and other payers. Management said they would price Provenge in line with other cancer treatments. I gave that a 10% or $5,000 haircut to come up with $45,000.
Row nine is my year-by-year forecast for Provenge sales in the U.S. only, on-label only. As you can see, the drug soars past $1.0 billion in 2014 and hits $1.5 billion the next year, five years after introduction.
So what's the stock worth?
A simple discounted revenue valuation model starts with Provenge sales of $1.5 billion in 2015. Apply an 80% risk adjustment and discount back five years to a net present value of $500 million today. Apply a typical revenue multiple of 6X and the enterprise value of Provenge today is about $3.0 billion. There are 98 million shares outstanding today, so $3.0 billion divided by 98 million shares is a little over $30 per share for every $1.5 billion in Provenge (or other) revenue in 2015.
When to Sell?
Certainly not before the April 28 meeting, which is likely to bump the stock to my $30 present value. After that will come the European marketing deal, a possible Japan/Asia deal, the filing of the Type 2 resubmission, and then approval next year. At NewWorldInvestor.com, we are looking at a strategy of swapping DNDN in May for a stock that will get approval for a revolutionary medical device this summer, then swap that for another biotech company with a Dendreon-like clinical win coming this fall in one of the biggest drug markets ever, and the swapping that back into Dendreon before the Type 2 resubmission. Seeking Alpha readers are welcome to look at my April 16 Radar Report by using the user name SEEKING and the password ALPHA, both all caps and good through April 29.
Considering the recession-impacted alternatives, biotech looks like a great sector to be in the right stocks for the rest of the year. One DNDN bear said that it's very inexpensive to bet against the long-term success of Provenge right now by buying out of the money puts. He's right - betting against the long-term success of Provenge is very inexpensive, because it is very stupid.
Disclosure: Long DNDN and DNDN call options
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This article has 100 comments:
Provenge offers no cure. Insurance isn't going to pay for Provenge in areas where there's no evidence of any efficacy or benefit versus current treatments. Would you rather get castrated or take Provenge and die of prostate cancer a few months later? That's how your question should have read.
<<<Well, would you rather be castrated or try Provenge,”>>>
The medical device he is talking about
"At NewWorldInvestor.com, we are looking at a strategy of swapping DNDN in May for a stock that will get approval for a revolutionary medical device this summer, "
is MelaFind, stock symbol MELA.
There is a chance to get a 25% to a 75% increase
this summer.
---------
I believe Magic Johnson is HIV+ but does not have AIDS - there is nothing wrong with his immune system.
On Apr 22 07:12 AM MeNotYou wrote:
> Why didn't the bubble boy die of cancer? Why hasn't Magic Johnson
> gotten cancer?
On Apr 22 07:12 AM Chicky401 wrote:
> I am kicking myself in the butt. I quickly saw this company before
> they started shooting up but didn't look that far into them, I was
> more into Cell Therapeutics. Therefore I didn't get in when their
> stocks were at their low. Then they jumped up almost $10 in a day!
> Oh well they are still going to grow so it is all good.
On Apr 22 08:35 AM neddie wrote:
> you're good but why haven't you updated your site date
Why publish the same article twice in a couple of days?
It makes sense when you sell used cars?
On Apr 22 09:34 AM hoopdreamerz@yahoo.com wrote:
> Your projections are out of control.
>
> Provenge offers no cure. Insurance isn't going to pay for Provenge
> in areas where there's no evidence of any efficacy or benefit versus
> current treatments. Would you rather get castrated or take Provenge
> and die of prostate cancer a few months later? That's how your question
> should have read.
>
> <<<Well, would you rather be castrated or try Provenge,”>>>
On Apr 22 09:54 AM erniewerner wrote:
> The comparator arm wasn't placebo, it was Taxotere. The primary
> endpoint was not a 22% risk reduction. It was a statistically significant
> p value from a Cox regression analysis. A 22% risk reduction was
> an approximation of what would be required to reach that p value.
On Apr 22 10:42 AM proteus_46 wrote:
>
> The medical device he is talking about
> "At NewWorldInvestor.com, we are looking at a strategy of swapping
> DNDN in May for a stock that will get approval for a revolutionary
> medical device this summer, "
>
> is MelaFind, stock symbol MELA.
>
> There is a chance to get a 25% to a 75% increase
> this summer.
On Apr 22 11:03 AM akcje wrote:
>
> Why publish the same article twice in a couple of days?
>
> It makes sense when you sell used cars?
Sorry, I take back my previous comment then.
(I have a policy of 30 day no charge returns :-)
= = =
On Apr 22 11:12 AM Michael Murphy wrote:
> Seeking Alpha now requires authors to first publish on their Instablog,
> and then submit the article for consideration to be published here.
> So everyone's article will get published twice in the future. Hey,
> it's their site.
On Apr 22 09:34 AM hoopdreamerz@yahoo.com wrote:
> Your projections are out of control.
>
> Provenge offers no cure. Insurance isn't going to pay for Provenge
> in areas where there's no evidence of any efficacy or benefit versus
> current treatments. Would you rather get castrated or take Provenge
> and die of prostate cancer a few months later? That's how your question
> should have read.
>
> <<<Well, would you rather be castrated or try Provenge,”>>>
If this cancer is androgen independant, why are we speaking of castration? This is a hormone refractory cancer, right?
On Apr 22 12:03 PM DAMGH wrote:
> The thing is, the next step is curing the cancer. There is evidence
> that it could work for a cure, and that is the final plan.
1) "At the time oIf the day comes that a doctor says: “Well, would you rather be castrated or try Provenge,” which would you choose?
if considering Provenge for its anticipated usage (at a time where prostate cancer is no longer responding to chemical castration- with the routine anti-androgen shot every 4 months and NOT a castration as in cutting off the testicles)
2) Finances and insurance coverage are a HUGE UNKNOWN VARIABLE and need to be taken into consideration. If my doctor asked me if I wanted to pay 25-30k per treatment for 3 treatments, I might not be able to pay for it if my insurance does not.
3) If all insurances cover Provenge in addition to existing expensive chemo, I would be happy as a clinician. Premiums will go up, and we will all be paying for it. So, buy the stock DNDN so you can pay your own health insurance premiums later.
Expensive treatments will not sell in a strapped financial medical system, there will be minimal cost savings, and the drug will not sell enough to get to over 100. Maybe over 60 in the next year.
I don't care either way, I bought my shares at $2.70
-McBride, RPA-C
1. Antiandrogen monotherapy appears to be less effective than medical or surgical castration and should not be recommended. The side effects are different but overall less tolerable.
2. Patients who do not achieve adequate suppression of serum testosterone (less than 50 ng/mL) with medical or surgical castration can be considered for additional hormonal manipulations (with estrogen, antiandrogens, or steroids), although the clinical benefit is not clear.
So the path appears to be castration first, then we discover it hasn't helped, then we classify the patient as androgen-independent and then move on.
But I am not sure about this, and welcome the comments of anyone who has better information on when and after what procedure the AIPC diagnosis is made.
On Apr 22 02:58 PM davveb wrote:
> AIPC
> If this cancer is androgen independant, why are we speaking of castration?
> This is a hormone refractory cancer, right?
In Urology, we've always said for AIPC patients "We need another drug." We've never said "You have prostate cancer, you need a castration." (It is an option, however, just not too popular.)
It may be helpful for the author to read more about AIPC in Urology, not oncology. It is where the diagnosis of AIPC is made, by failure of PSA to go down, and then rise, after the use of antiandrogens.
The utility of Provenge falls into a narrower window than the author is suggesting- it is for the roughly 1 in 100 of my patients. Most are caught early and in low enough Gleason score (severity/aggressiveness) and are even choosing watchful waiting as a perfectly logical and medically sound choice. Once the PSA rises aggressively, then antiandrogens are started. If they fail antiandrogens, then we have AIPC and would start Provenge.
Your suggestion that Provenge will be started at initial diagnosis is misleading, and should be modified according to real treatment protocols in urology and oncology.
The author could consider revising his numbers based on the amount of patients who develop AIPC each year.
That will decrease the need for Provenge, streamline its use so that even insurance will pay for it, and hopefully it will be a good adjunct.
Time will tell if studies will be performed about Provenge as a primary therapy for prostate cancer. Can anybody tell me why it wouldn't be studied as a primary monotherapy for prostate cancer (non-AIPC?)
This company DNDN, and immunotherapy, all harbor AMAZING POTENTIAL.
You also might be interested to know that DNDN has already virtually completed a Phase 3 trial (PROTECT, aka P-11) in an earlier stage of prostate cancer (ADPC), whereby patients in the experimental arm get three infusions of Provenge after they complete a course of Lupron that has lowered their testosterone level to zero. Then, approximately 18 months later, they get a booster dose of Provenge. The control arm received Lupron and sham Provenge (saline solution). The primary endpoint was the time it takes one's PSA count to double, and the secondary endpoint was the time it takes to develop distant metastases. Both endpoints looked good, with the primary a little better than p=0.05, but because of the length of time this stage of the disease usually takes, the dataset was incomplete for the secondary endpoint when they announced preliminary results back in 2006. Only 16% of the total of the patients in the trial had developed metastases on their bone scans, but the hazard ratio (HR) measurement showed that the patients in the Provenge arm were 27% less likely to have developed bone metastases (HR=0.73).
The hormone sensitive market treated in the PROTECT trial is probably four or five times greater than that of the hormone refractory market treated in the recently announced IMPACT trial. So, there is huge potential here.
what's your estimate after approval?
Thanks
On Apr 22 11:09 AM Michael Murphy wrote:
> You're way low.
On Apr 22 11:06 AM Michael Murphy wrote:
> In the follow-up to the prior Phase III studies, after three years
> 34% of the men who were in the Provenge arm were alive, compared
> to 11% in the placebo arm. Do you not consider that "evidence of
> any efficacy or benefit versus current treatments?" How about the
> very low side effect profile for Provenge versus Taxotere? And if
> "insurance isn't going to pay for Provenge" then why do they pay
> for an inferior drug like Taxotere?
everything on this article hinges on a prediction over 15 years!!!
if nobody predicted the current bloody mess three years ago, how could you even hope to predict what will happen 15 years from now?
do you realize how crazy that sounds? 15 years into the future? nobody can even predict if CitiGroup will survive in the next 12 months!
thehatemongers.blogspo...
The payers cover Avastin, which extends life 5.5 months on average. How could they justify not covering Provenge for this population with even fewer options?
On Apr 22 03:33 PM McBride, RPA-C wrote:
> This article is technically wrong.
>
> 1) "At the time oIf the day comes that a doctor says: “Well, would
> you rather be castrated or try Provenge,” which would you choose?
>
>
> if considering Provenge for its anticipated usage (at a time where
> prostate cancer is no longer responding to chemical castration- with
> the routine anti-androgen shot every 4 months and NOT a castration
> as in cutting off the testicles)
>
> 2) Finances and insurance coverage are a HUGE UNKNOWN VARIABLE and
> need to be taken into consideration. If my doctor asked me if I
> wanted to pay 25-30k per treatment for 3 treatments, I might not
> be able to pay for it if my insurance does not.
>
> 3) If all insurances cover Provenge in addition to existing expensive
> chemo, I would be happy as a clinician. Premiums will go up, and
> we will all be paying for it. So, buy the stock DNDN so you can
> pay your own health insurance premiums later.
>
> Expensive treatments will not sell in a strapped financial medical
> system, there will be minimal cost savings, and the drug will not
> sell enough to get to over 100. Maybe over 60 in the next year.
>
>
> I don't care either way, I bought my shares at $2.70
>
> -McBride, RPA-C
$60 is fine for Provenge alone, U.S. and Europe, on-label only. That's my estimate, too. Another $60 when breast cancer is approved? Another $60 when a few more cancers are approved?
On Apr 22 03:33 PM McBride, RPA-C wrote:
> This article is technically wrong.
>
> 1) "At the time oIf the day comes that a doctor says: “Well, would
> you rather be castrated or try Provenge,” which would you choose?
>
>
> if considering Provenge for its anticipated usage (at a time where
> prostate cancer is no longer responding to chemical castration- with
> the routine anti-androgen shot every 4 months and NOT a castration
> as in cutting off the testicles)
>
> 2) Finances and insurance coverage are a HUGE UNKNOWN VARIABLE and
> need to be taken into consideration. If my doctor asked me if I
> wanted to pay 25-30k per treatment for 3 treatments, I might not
> be able to pay for it if my insurance does not.
>
> 3) If all insurances cover Provenge in addition to existing expensive
> chemo, I would be happy as a clinician. Premiums will go up, and
> we will all be paying for it. So, buy the stock DNDN so you can
> pay your own health insurance premiums later.
>
> Expensive treatments will not sell in a strapped financial medical
> system, there will be minimal cost savings, and the drug will not
> sell enough to get to over 100. Maybe over 60 in the next year.
>
>
> I don't care either way, I bought my shares at $2.70
>
> -McBride, RPA-C
I really appreciate your comments. This is a tough number to ferret out, but it looks like just under 80,000 a year now and growing. Do you have another estimate?
On Apr 22 04:18 PM McBride, RPA-C wrote:
> When a patient is diagnosed with prostate cancer, it is intially
> though to be 100% androgen dependant, then the neighboring cells
> either mutate and are influenced by some other hormone or chemical
> (as the testosterone is robbed by antiandrogen therapy), or perhaps
> the mutant cells are hypersensitive to testosterone.
>
> In Urology, we've always said for AIPC patients "We need another
> drug." We've never said "You have prostate cancer, you need a castration."
> (It is an option, however, just not too popular.)
>
> It may be helpful for the author to read more about AIPC in Urology,
> not oncology. It is where the diagnosis of AIPC is made, by failure
> of PSA to go down, and then rise, after the use of antiandrogens.
>
>
> The utility of Provenge falls into a narrower window than the author
> is suggesting- it is for the roughly 1 in 100 of my patients. Most
> are caught early and in low enough Gleason score (severity/aggressiveness)
> and are even choosing watchful waiting as a perfectly logical and
> medically sound choice. Once the PSA rises aggressively, then antiandrogens
> are started. If they fail antiandrogens, then we have AIPC and
> would start Provenge.
>
> Your suggestion that Provenge will be started at initial diagnosis
> is misleading, and should be modified according to real treatment
> protocols in urology and oncology.
>
> The author could consider revising his numbers based on the amount
> of patients who develop AIPC each year.
But I will stick to my guns - Provenge is compatible with most other treatments due to the very different mechanism of action, and I think usage will spread to earlier stages in addition to current therapies.
On Apr 23 08:17 AM hoopdreamerz@yahoo.com wrote:
> Mike, you aren't following me at all. Prostate cancer is inherently
> treatable if caught early. You're dreaming if you think this is going
> extend to early lines of treatement where there's no proven benefit
> and it would be suicide to take provenge in place of existing standards
> of cure and continue to progress albeit possibly a little bit slower.
> Plus insurance won't pay anyway so it's a moot argument you're making.
> Don't get me wrong, i'm long dndn but your $360 projection is just
> bad research. The trial was in AIPC, that's where the approval will
> be and that's where it will be used and that's all that will be paid
> for. Stick to the facts. I also wouldn't assume the technology will
> work in other cancers.
On Apr 22 09:09 PM proteus_46 wrote:
> I hope you're right Mike. Right now MELA is in the mid 6's...
> what's your estimate after approval?
>
> Thanks
On Apr 23 12:59 AM stockhere wrote:
> A typical pump and dump.
On Apr 23 05:22 PM Michael Murphy wrote:
> Nope, no sale recommendation coming for long-term and taxable accounts.
> For traders, there's an opportunity to trade DNDN>>MELA>&a...
> by the end of the year, but we'll be in the stock the day the FDA
> approves Provenge next year.
On Apr 23 05:23 PM Michael Murphy wrote:
> Should have read DNDN>>MELA>&a...
On Apr 23 12:59 AM stockhere wrote:
> Typical pump and dump designed to scare off the shorts.
On Apr 23 06:02 AM Kobe wrote:
> Did you forget about the likelihood of a massive capital raise? If
> it hits $30 in a few days, look for 100,000,000 new shares to hit
> the market.
On Apr 23 08:00 AM Topgun wrote:
> you crazy? 360? R u 6 years old who didn't live thru dotcom bubble?
Second, I did predict this bloody mess - in print and speeches - and the day Bernanke was appointed I wrote that I doubted he would finish out his term.
Third, almost every stock in the market includes predictions more than 15 years away. Stocks are worth the discounted value of their dividends. Discount only the next 15 years of dividends and you'll be shocked at how low the numbers are for most companies. The market is discounting much further out.
On Apr 23 02:17 PM the_lazy_observer wrote:
> this is bordering on WILD speculation.
> everything on this article hinges on a prediction over 15 years!!!
>
> if nobody predicted the current bloody mess three years ago, how
> could you even hope to predict what will happen 15 years from now?
Merck is buyng the wrong company.
On Apr 23 04:28 PM hoopdreamerz@yahoo.com wrote:
> Mike, you continue to not understand that insurance will not pay
> for this off label. It's irrelevant whether it would be useful or
> not in early stage unless dndn decides to run a pivotal trial. Another
> poster had it right, you're still living in the dot.com era. Your
> price target is far greater than what Merck is paying for Schering
> Plough by the way.
..zzz..
On Apr 22 11:02 AM Michael Murphy wrote:
> This article took a week to get published due to the table. The free
> access date is now through April 29. I've asked Seeking Alpha to
> change the date in the text if they can.
a) The trial was compared against placebo - gimme a break - you've got to be kidding if you think that this study against - placebo as a comparitor, will make this into a $36B company. LOL ! Take a look at the competitive landscape - not just what's out there, but what is likely to be approved over the next 5 years - late stage investigational agents, esp. when combined with existing therapies.
b) Relative paucity of clinical trials & data: It will take more than one trial against placebo to drive uptake - we're talking multiple studies that will take years to complete and publish - and millions in development costs. To fund these trials will require dilution of existing equity. Think "tiime for the competition to produce more compelling data" Do you think avastin would be where it is without hundreds of millions laid out in clinical trials?
b) Ease of administration - take a look at this product and the steps required to administer. Compare this to the convenience of an oral agent or even weekly or biweekly IV regimen. Ease of use - to the oncologist and the patient are key drivers of success. If you think this product will have rapid update when/if approved, you had better take a look at the history of abraxane (despite its' compelling data relative to pac.), lapatinib, etc.. Oncologists don't change their standard practice in months, or even a few years. And most importantly, the biggest market potential is in first & second-line therapy - a niche this product is unlikely to dominate.
c) Still a one trick pony - thus risky. Stock driven up by lay people who look only at headlines and not at the data: methodolody too - not just results.
d) Why would you put $ into this company when you can buy something like EXEL that has multiple agents in development with validated targets
It is human nature to be overly-optimistic at the wrong time. Before diving in and buying, take a time to comb through the data - find a friend that is a scientist to help you out if you are a lay person. This stock will make many ups & downs in years to come - and it is probably more prudent to wait a few years to see what sales are (vs. projections of analysts who are on the postive hype bandwagon) so the company can be valued with a lot more accuracy & precision. Otherwise you can end up owning another amylin, KERX, etc..
"The payers cover Avastin, which extends life 5.5 months on average."
This statement is incorrect. Avastin did extend life 5.5 months in a single registration trial when was used with an old chemo (Iranoticane) regiment in mCRC. With new chemo (Folfiri or Folfox), Avastin did not show any statistically significant overall survival (OS) benefits in mCRC.
Furthermore, even Avastin is approved in breast and lung cancers, it did not show any OS benefits in breast and just 2 months OS benefits in a subset of lung patients (~40% of all patients).
IMHO, Avastin with its $4B+ world sale is a very marginal oncology drug with too many very serious side-effects.
You're thoughts and projections are reminding me of the Elan bulls a few years ago, it was going to get 100% market share and be the largest selling drug of all time.
But it still has a long way to go, no approval until 2010 and we won't know who's right until sometime in 2011. I do think you'd be wise for your newsletter credibility to take a reality check and set more realistic expectations.
Thanks for attracting some interesting debate on here.
On Apr 23 05:43 PM Michael Murphy wrote:
> Before the approval of Rituxan, every treatment for b cell lymphoma
> was off-label, and insurance paid for all of them. If doctors establish
> a standard of practice, the payers follow. And, of course, DNDN will
> run those trials.
>
> Merck is buyng the wrong company.
Anyway, I'm VERY up on this one so sitting pretty. Shorts and trolls can eat my... shorts.
I have never seen a professional using numbers so irresponsibly.
You make a strong case for a $4-5 billion company. If they continue executing and cut great marketing deals.
There is probably another 100-150% of upside in this stock, if one has the guts for the wild ups and downs that a stock like this goes through.
Their CMC and manufacturing capacity is unique yet completely transferrable to other indications earlier in their pipeline, which gives them a tremendous advantage moving forward in this field over their competitors (who now are abandoned cars on the side of the highway.) No near term worries regarding the Tevas of the world taking away market share.
Great LT investment; I look for 50-60 in 2-3 years as well.
Your all hype.
I think that, within a few years' time, every single one of them will ask and have treatment with Provenge.
But let's assume 80,000 will take it.
Each Provenge treatment will reportedly cost $40,000 (I mean the whole treatment: blood taking, then three infusions),
80,000 x 40,000 = € 3,200,000,000.00.
In a few years' time, with stabilization of financial market, DNDN might fetch 10x sales.
This gives me a market cap of 32,000,000,000.00.
For simplicity's sake (but it should not be much far from reality) I assume there will be 100,000,000 DNDN shares (2007 annual report share count is 82,531,000).
This gives me a pps of $320.00.
This excludes ROW (almost a triple if we just count the EU, Japan, the so-called "western world". Think India, think China....... vbg)
All of the above excludes:
1 - Neuvenge;
2 - the treatment that DNDN will be able to develop against Carcinoembryonic antigen (CEA) - actually in pre-clinical phase - lung, colon, breast cancer;
3 - Carbonic anhydrase IX (CA9) - cervical, colon, renal, cancers (pre-clinical phase);
4 - the small molecule against Trp-p8 - prostate, breast, colon, lung cancers (moving from pre-clinical into clinical phase).
This is a revolution: many people, diagnosed with cancer, will live longer and better thanks to Dendreon.
Among the NOs, Dr. Sher and Dr. Hussain.
Provenge achieved a 200% increase in overall survival measured at 3 years… with multiple recipients alive and well over 6 years later.
27,000 men with end-stage prostate cancer will die needlessly early (some will die needlessly period) each year the Provenge is delayed by the FDA.
Certainly FDA has approved drugs against the recommendations of its advisory panel, but I am not aware of a decision to overrule a strong positive panel vote for a terminal illness that has no really acceptable treatment options. This decision would appear to be unprecedented, and calls for a full and open public statement of why the FDA disagrees with this panel and cannot make this drug available to terminal patients. We know of course it was not due to safety concerns. Also, if FDA found the clinical trial data submitted by Dendreon (Provenge producer company) to be insufficient, why did it even submit the data to a panel of experts for their opinions?
Some of those doctors that voted “NO” as to the effectiveness evidence even had letters (urging the FDA NOT to approve Provenge) “leaked” to the media. They were Dr. Sher and Dr. Hussain. I let you judge on the ethics of this behaviour.
On May 30, 2007, news was that Schering-Plough Corp. said it had agreed pay Novacea Inc. up to $440 million for rights to develop the smaller drugmaker’s prostate cancer treatment, causing Novacea shares to double.
Both Dr. Sher and Dr. Hussain are Novacea consultants.
Do you think Schering-Plough would have paid $60 million immediately and an additional $380 million to Novacea if Provenge was on the market?
Why the FDA - for the first time in its history - did not approve a drug deemed safe and effective by its own panel?
How is that Dr. Sher and Dr. Hussain - with their obvious and enormous conflicts of interest - took part in the panel?
Who did choose Dr. Sher and Dr. Hussain?
We already have proof that Provenge works (two phase III trials). Many people are going to die due to the delay. Who is accountable?
Why isn’t this revolutionary and extremely safe treatment available NOW?
I can’t imagine the motives are about monetary gains.
There's now a third pIII trial that shows that Provenge works (details tuesday 28 april 2009).
Since the FDA issued the Approvable Letter and delayed patient access to Provenge, 59,511 men have now suffered painful deaths from prostate cancer. Provenge could have likely extended the lives of many of them for months, and for some, perhaps years. It could have spared some of them the horrible side effects of chemo treatments.
Many more men continue to be unnecessarily at risk for a premature and painful death due to the lack of approval and availability of this life-saving cancer therapy, despite the fact that we received crystal clear confirmation that Provenge works and works so well that it met its trial endpoints "unambiguously" and "robustly". Until Provenge is approved by the FDA, the advance of immunotherapy technology generally, which is inherently better and more promising than chemotherapy and other current treatments, as well as many other progressive medical technologies desperately needed by sick and dying patients, continues to be stymied.
WHO IS ACCOUNTABLE?
Do you really know much about what you are discussing? Castration as a treatment for prostate cancer?!!?!?! In what country? In what time?
It is difficult to take seriously any of your assumption or 'logic' that follows.
I guess the question most appropriate to ask you is...
"Well, would you rather be castrated or try writing about things of which you have a decent understanding?".
dollar stock.
Go to newworldinvestor.com
On Apr 23 07:30 PM Lawrence Sinclair wrote:
> The password/user name simply do NOT work - in either order... frustrating!
> plus the only post I see on the site is from FEB!
> ..zzz..
On Apr 26 09:34 PM Ames Tiedeman wrote:
> Let's see this thing approved by the FDA before we start talking
> about a 360
> dollar stock.
Quarter Revenues(M) YOY Growth
Q1:07 $1.581
Q2:07 $1.632
Q3:07 $1.765
Q4:07 $1.906
Q1:08 $2.082 +32%
Q2:08 $2.494 +53%
Q3:08 $2.870 +63%
Q4:08 $3.210 +68%
Q1:09 Coming May 6
Isn't that awful? Any management that can only grow its revenues over 50% YOY in this environment should have their stock knocked under $1, don't you think? Yeah, they are showing accelerating growth, but the idiots cut back their expansion plan to get profitable quicker so they wouldn't have to go to the capital markets. Dummies. Bernanke probably would have bailed them out. And now that they're about to turn EBITDA positive and are creaming the telcos in nine major markets, who would ever want to buy their stock? Especially since the insiders own 30% of it, and are running the company like they plan to get rich? <sarcasm off>
On Apr 24 04:58 PM TheSnail wrote:
> How's that January 2008 call on Towerstream working out for you their
> Mickie?
>
> Your all hype.
On Apr 22 07:12 AM MeNotYou wrote:
> Why didn't the bubble boy die of cancer? Why hasn't Magic Johnson
> gotten cancer?
So what is the real underlying mechanism of Provenge to induce longer survival of prostate cancer patients while it does not have effect to cause direct shrinkage or reduction of tumor itself?
How could
now my 1000 9$ put contracts are looking like they'll be quite valuable by end of week
jaberwoky
Four plus months is just that, and when your circling the drain.. it is a life time. I'll take it..literally.
and that's from within the medical community. Very insightful, Thanks.
Answer: Whether there are any imbalances in the arms of the study, whethter the results were driven by one or more subgroups etc... top line data is often misleading. Details are crucial in clinical trials.
"This trial was done under a Special Protocol Assessment – you hit your numbers, you get approval. "
This is just simply wrong. The SPA is absolutely NOT a guarantee of ANY kind and that fact is clearly evident with modest due dili.
"He was the one who sabotaged FDA approval in May, 2007, even after the Advisory Committee recommended approval. Even the last head of the FDA, himself a prostate cancer survivor, could not overpower this guy. Provenge has very minor side effects, but because the FDA turned the drug down, many men died needlessly in the last two years. Someone will write a book someday about this shameful blot on the FDA's reputation. "
Wrong! The prior DNDN trials FAILED! You can't choose your endpoint AFTER THE FACT. Those trials were NOT powered for survival. As such, they were a good basis for doing a survival trial, but not a good basis for approval. The FDA has NEVER EVER approved anything on a failed trial. And lets not get carried away - this treatment extends life by a median of 4 months based on what we know now. That is great and I am very happy. But it is not a cure as you suggest. Unfortunately, these patients will ultimately lose their battle with this horrible disease.
The clinical development of this vaccine has been a comedy of errors from the start. Gleason sub 7, no wait, not Gleason sub 7, time to progression, no wait, survival! File on failed trial, oops! This is the reason analysts were skeptical until they saw the actual data. Nobody would take anything this mgmt team said at face value and that is as it should be. They have been horrible. Having said that, we now have a clear success and thank god there is another option for pts.
Unless they invent a drug that prevents death for eternity, $360, $260, or even $160 is not going to happen!
well, April 28 has come and gone... and not only did the stock had a rollercoaster ride crazy enough to induce prostrate cancer, it's still nowhere near $30.
On Apr 29 01:00 PM buyforeclosures wrote:
> Mr Murphy you must be the guy who made the post about 9000 buck gold!
> WAY too early to be making post like this ... just because your long
> and have option calls.... very irresponsible on your part
On Apr 30 02:35 AM the_lazy_observer wrote:
> "Certainly not before the April 28 meeting, which is likely to bump
> the stock to my $30 present value."
>
> well, April 28 has come and gone... and not only did the stock had
> a rollercoaster ride crazy enough to induce prostrate cancer, it's
> still nowhere near $30.
On Apr 28 04:04 PM jaberwoky wrote:
> So Michael - I had recommended buying puts on google finance, so
> I feel particularily tied to your comment where my investment strategy
> was...as you put it:stupid.
>
> now my 1000 9$ put contracts are looking like they'll be quite valuable
> by end of week
>
> jaberwoky
On Apr 27 10:53 PM User 403263 wrote:
> do you know how to get to the under the radar article on April 16
>
On Apr 28 01:07 PM hiwind88 wrote:
> Provenge does not cause prostate cancer or tumor to shrink in size,
> according to the clinical trial data released previously.That means
> it has no direct effect on tumor itself. NO EFFICACY.
>
> So what is the real underlying mechanism of Provenge to induce longer
> survival of prostate cancer patients while it does not have effect
> to cause direct shrinkage or reduction of tumor itself?
>
>
>
>
> How could
On Apr 29 08:06 PM JasonMichael wrote:
> Okay, I just tried finding a drug stock that was over $100, and could
> not find one. Nothing comes even close, at this time. Why would
> the author suppose that this stock could hit $360?
>
> Unless they invent a drug that prevents death for eternity, $360,
> $260, or even $160 is not going to happen!
On Apr 28 01:45 PM Repsonsible Citizen wrote:
> ROFLMAO , this is the 2nd Time in Three Years this BS was put out
> ! Stock quadruples in a hour then Crashes 2 weeks later . Theres
> a Sucker Born every minute . I bought mine at $6 Sold a week later
> for $21. When will people do there home work ???
2. The Advisory Committee voted 13-4 that Provenge was efficacious, based on the trial data presented in 2007. You say the trials "failed" because they didn't shrink tumors, but only extended survival. The Advisory Committee said the trials showed efficacy. The FDA agreed with your position. Now we know that the Advisory Committee was right, Provenge is safe and efficacious. You and the FDA were wrong, and many men unnecessarily died early as a result.
On Apr 29 09:24 AM sdt993 wrote:
> "It seems unlikely to me that the data presentation on April 28 will
> show Provenge did not meet the 22% goal – their next call would be
> from the SEC. In light of words like”unambiguous” and “clear hit,”
> one wonders exactly what additional data this analyst needs to see."
>
>
> Answer: Whether there are any imbalances in the arms of the study,
> whethter the results were driven by one or more subgroups etc...
> top line data is often misleading. Details are crucial in clinical
> trials.
>
> "This trial was done under a Special Protocol Assessment – you hit
> your numbers, you get approval. "
>
> This is just simply wrong. The SPA is absolutely NOT a guarantee
> of ANY kind and that fact is clearly evident with modest due dili.
>
>
> "He was the one who sabotaged FDA approval in May, 2007, even after
> the Advisory Committee recommended approval. Even the last head of
> the FDA, himself a prostate cancer survivor, could not overpower
> this guy. Provenge has very minor side effects, but because the FDA
> turned the drug down, many men died needlessly in the last two years.
> Someone will write a book someday about this shameful blot on the
> FDA's reputation. "
>
> Wrong! The prior DNDN trials FAILED! You can't choose your endpoint
> AFTER THE FACT. Those trials were NOT powered for survival. As such,
> they were a good basis for doing a survival trial, but not a good
> basis for approval. The FDA has NEVER EVER approved anything on a
> failed trial. And lets not get carried away - this treatment extends
> life by a median of 4 months based on what we know now. That is great
> and I am very happy. But it is not a cure as you suggest. Unfortunately,
> these patients will ultimately lose their battle with this horrible
> disease.
>
> The clinical development of this vaccine has been a comedy of errors
> from the start. Gleason sub 7, no wait, not Gleason sub 7, time to
> progression, no wait, survival! File on failed trial, oops! This
> is the reason analysts were skeptical until they saw the actual data.
> Nobody would take anything this mgmt team said at face value and
> that is as it should be. They have been horrible. Having said that,
> we now have a clear success and thank god there is another option
> for pts.
>
>
In 3-5 years, the odds are much greater that DNDN will be selling at $0 than $360. The price for their drug is completely ridiculous and it only extends the life of the patient by one month over its closest rival. Big whoop. Just another example of irrational exubberance at work.
that the entire time before AIPC developed, and often to continue combating the androgen-dependant cell line, the antiandrogen drugs are still continued...as well as Casodex (and rarely, DES) pills...
Let's see...for complete androgen blockade for palliative therapy of metastatic prostate cancer-
Lupron....costs around $1,000/month,
Casodex...just around $300/month,
FOR YEARS!!!!
Then, AIPC develops, Taxotere $40,000 per each 10 weeks course...and the Lupron and Casodex are continued...
vs....
30,000 x 3? Hmmmm.
Either way a boatload of money is being spent on these drugs...and chemo and antiandrogens need to be subject to another treatment in order to bring the costs of ALL of them down by competition (ahhhh.....capitalism in medicine???)
On Apr 23 10:11 PM User 401085 wrote:
> why are insiders selling
Perhaps we should think about how important Provenge and immunotherapy might become...
Why wait until prostate cancer is metastatic? Why wait until expensive anti-androgens have failed?
Should we also be studying how Provenge would do if started as soon as PSA rises after anti-androgens? (not when radiographic evidence of metastatic disease is apparent, as required in the trials) Might we change the way prostate cancer is treated or defeated?
If a technology is used more often, generally the product or service becomes cheaper to the healthcare consumer (see also: decline in CT scan reimbursement over the years) because the insurances have to lower the reimbursements or go bankrupt. In fact, some of them are close to bankrupt, and this treatment may very well be "self-pay" until it gains ground.
Anyone who has ever worked in medicine or drug sales would tell you...self pay (or "fee for service") is absolutely the best way to get paid. With insurances, you are lucky to collect 0.30 per dollar...
This drug is going to sell well, take well-educated and well-advised patients out of the chemo realm, possibly have them spending their own money initially, driving early cash sales and outcome data that will have insurances interested in keeping their patients away from sickening and less-effective, nearly equally expensive chemo...
Mark my words and hit the green thumb up please, and buy DNDN long.
You can't approve a drug on this basis and most companies don't even try. Most will go on to do the kind of trial that DNDN just did and many of those will fail. The success rate in Phase III oncology trials is something like 33% so plenty of drugs look promising and then fail to pan out. Thus, the suggestion that men died as a result of the drug being delayed is meaningless. If there is blame, it should be laid on the company mgmt who failed to deliver approvable data, not on those who simply pointed out the inadequacy of the data. By your logic, anything that shows promise or a hint of activity should be approved, and if it isnt, the FDA is wrong. Thats not how it works Michael.
As for SPA drugs being dinged:
Take a look at the history of satraplatin - ironically - in HRPC pts. SPA on the SPARC trial. Showed 33% reduction in the risk of disease progression, consistent across all pre-defined subsets etc...etc....
www.medicalnewstoday.c...
www.in-pharmatechnolog...
www.reuters.com/articl...
Just because a company SAYS they hit their endpoints on an SPA doesnt mean the FDA will agree with the data or how the trial was conducted. You don't know what they will find in the statistical package because it ISNT PUBLIC. You only find out after the FDA statisticians go through the package and rip it to shreds. How do you know DNDN didn't exclude certain patients from the analysis that the FDA thinks should have been included? How do you know there wasnt some significant imbalance in the arms that favored provenge? These things happen all the time, trust me. It ain't over till its over and the drug is approved.
on that note does SQNM have a chance to come back? under $3 right now but lawsuits up the gazooooooooooo
On Apr 30 02:52 AM Michael Murphy wrote:
> Which part of the earnings and valuation model do you disagree with?
>
I did not know the fascinating history of satraplatin, so I will never again say "you hit your numbers, you get approval" without at least adding that you have to hit the numbers as the FDA reads them. Of course, I have no way of knowing if DNDN cheated, although my read on them is that the CEO is more interested in developing an effective drug than just cashing in.
So I have to discount my targets for a low but possible probability that they cheated. I still think the model above is valid, and the stock is a steal.
On May 07 05:53 PM sdt993 wrote:
> Michael, with all due respect, the FDA and I were not wrong. The
> criteria for getting a drug approved are quite clear. At the time
> of the panel, DNDN did not, i repeat, did not have a successful trial,
> nor sufficient evidence for approval. Your contention that it "only
> extended survival" is simply incorrect. The data SUGGESTED that the
> drug might extend survival but did not PROVE it because it was not
> designed to do so. This is classic data dredging. A basic understanding
> of biostats would make this obvious to anyone. Indeed, one of the
> three experts who came out publicly in writing against approval (something
> i have never seen before or since) based on the earlier studies was
> prominent biostatistician (and often time FDA advisory committee
> member) Tom Fleming. His letter is available on the internet and
> was published May 4, 2007 in "The Cancer Letter". He goes into great
> depth explaining exactly why the earlier data was unreliable AND
> notes the fact that it showed a 3 fold increase in cerebrovascular
> events in the provenge arm.
>
> You can't approve a drug on this basis and most companies don't even
> try. Most will go on to do the kind of trial that DNDN just did and
> many of those will fail. The success rate in Phase III oncology trials
> is something like 33% so plenty of drugs look promising and then
> fail to pan out. Thus, the suggestion that men died as a result of
> the drug being delayed is meaningless. If there is blame, it should
> be laid on the company mgmt who failed to deliver approvable data,
> not on those who simply pointed out the inadequacy of the data. By
> your logic, anything that shows promise or a hint of activity should
> be approved, and if it isnt, the FDA is wrong. Thats not how it
> works Michael.
>
>
> As for SPA drugs being dinged:
>
> Take a look at the history of satraplatin - ironically - in HRPC
> pts. SPA on the SPARC trial. Showed 33% reduction in the risk of
> disease progression, consistent across all pre-defined subsets etc...etc....
>
>
> www.medicalnewstoday.c...
>
> www.in-pharmatechnolog...
>
>
> www.reuters.com/articl...
>
>
> Just because a company SAYS they hit their endpoints on an SPA doesnt
> mean the FDA will agree with the data or how the trial was conducted.
> You don't know what they will find in the statistical package because
> it ISNT PUBLIC. You only find out after the FDA statisticians go
> through the package and rip it to shreds. How do you know DNDN didn't
> exclude certain patients from the analysis that the FDA thinks should
> have been included? How do you know there wasnt some significant
> imbalance in the arms that favored provenge? These things happen
> all the time, trust me. It ain't over till its over and the drug
> is approved.
>
On May 08 08:01 AM Kobe wrote:
> Mike, you are now officially a Dendreon pumper... as predicted...the
> company is issuing shares...