Comments on Dan Rosenblum's articles RSS Syndication from SeekingAlpha.com http://seekingalpha.com/author/dan-rosenblum/articles http://seekingalpha.com/article/78913-asco-whose-presentations-look-the-most-promising?source=feed#comment-578319 578319 Wed, 08 Jul 2009 01:20:50 -0400 http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-523547 523547 Fri, 29 May 2009 18:56:15 -0400 http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-514446 514446 $4 billion per year to keep a handful of geezers alive for a month? > If ever there were evidence that this country has got its priorities > totally screwed up, this is it. I'm not in favour of Soylent Green, > but $4 billion can be put to much better use in public health. Especially > if it's a month more in a hospice bed.]]> Fri, 22 May 2009 11:27:30 -0400

On May 18 11:34 PM Robert0713 wrote:

> $4 billion per year to keep a handful of geezers alive for a month?
> If ever there were evidence that this country has got its priorities
> totally screwed up, this is it. I'm not in favour of Soylent Green,
> but $4 billion can be put to much better use in public health. Especially
> if it's a month more in a hospice bed.]]> http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-514439 514439 >>Of the 230,000 new prostate cancer patients per year, roughly 80-85% > of them will fail hormone therapy at some point.<< > > That's nonsense. Roughly 80-85% of them never even begin hormone > therapy (actually hormone DEPRIVATION therapy) because they are completely > cured of their prostate cancer or die of something else before it > becomes a problem.]]> Fri, 22 May 2009 11:20:00 -0400

On May 18 06:38 PM micro wrote:

> >>Of the 230,000 new prostate cancer patients per year, roughly 80-85%
> of them will fail hormone therapy at some point.<<
>
> That's nonsense. Roughly 80-85% of them never even begin hormone
> therapy (actually hormone DEPRIVATION therapy) because they are completely
> cured of their prostate cancer or die of something else before it
> becomes a problem.]]> http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-513519 513519 Thu, 21 May 2009 17:15:28 -0400 http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-512401 512401 Thu, 21 May 2009 03:50:01 -0400 seekingalpha.com/artic..., I used only $45,000 per treatment and only 33,000 patients after five years, and Provenge is a $1.5 billion drug, US, on-label. We all know the ROW market is about the same size. We all know there will be some, if not extensive, use of the drug off-label, say only $500 million in the US and an equal amount in ROW. That gets revenues up to $4 billion after ROW approval. The technology should work on any solid tumor cancer, so I think you can double the $4 billion at least for the eventual approvals for breast, colon, head & neck and other cancers. As all this unfolds, I expect the analysts to stay behind the curve all the way up. As Gold pointed out in Boston, not one analyst is looking for more than $50 million in sales in 2010, when they will have 6 months to market. I am at $117 million in 2010 and $238 million in 2011.]]> http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-512292 512292 Wed, 20 May 2009 23:36:31 -0400 http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-512076 512076 Wed, 20 May 2009 18:41:40 -0400 http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-511356 511356 Wed, 20 May 2009 11:30:53 -0400
However I would point out that yesterday in Boston at investor meetings ,the Dendreon CEO Mitch Gold hinted at pricing of Provenge around $80,000 per patient. He aso stated that the potential market size for the drug was around 100,000 patients per year.

So even if they capture only half the potential market that makes it a $4 billion dollar drug, higher than my estimate .]]> http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-510651 510651 Tue, 19 May 2009 23:16:56 -0400
Provenge history refresher:

Published on: psa-rising.com
The Unreachable Unavailability of Provenge
*FDA’s mission statement: To promote and protect public health.
Terminal patients are those who are not expected to live due to usually illness such as advanced prostate cancer (cT3). If the patient has 6 months or less to live, those patients are considered terminally ill.
Regardless, if a patient is terminal, they are without a cure or tolerable treatment for their illness presently. Since such patients will likely die in a short period of time, treatment options, even if they are not entirely unproven, are often desired by such patients.
This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues.
The Food And Drug Administration (FDA), however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually. Reform has to start somewhere at some time.
Prostate cancer is a rather frequent occurrence- with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease of the one million men. Furthermore, out of all cancer types more are dying from prostate cancer now than other cancer diagnoses.
For those unaware, there are different stages of prostate cancer, and the more severe the prostate cancer cases are which is determined by such methods as bone scans and Gleason’s scores, which is a score that assesses prostate tissue after it is biopsied and if it is determined that the stage of cancer is severe by this and to estimate proper treatment options if proven to be malignant.
Typically, the initial suspicion of prostate cancer is determined by the results of what is called a PSA blood test, as PSA is a protein produced by prostate cancer cells. If the PSA blood test is above normal limits, a prostate biopsy is performed to determine and confirm not only the presence of cancer, but also the severity of the disease on such a patient.
Yet fortunately, and as you will read, innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge.
Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients, and has proven to be a very novel and innovative treatment option for advanced prostate cancer patients who are terminally ill.
Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer.
Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as taxotere. The immunotherapy method developed by Dendreon required the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack what is called PAP, which is on prostate cancer cells only.
This treatment required only three such injections in a period of six weeks. This resulted in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients.
While Provenge was on fast track status at this time at the FDA, the FDA panel thankfully recommended with clarity the approval of Provenge based on its proven and substantial efficacy and safety demonstrated in its performance in past trials. The FDA announced this to the public in the early Spring of 2007, I believe.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself!
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea.
Novacea had signed a co-promotion agreement with Schering with this similar prostate cancer drug being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge.
As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment.
Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as Provenge at the end of last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them.
At this stage of such a patient, one could argue, safety of any treatment option is not of concern to these patients, because they are going to die anyway. Yet the FDA, with reckless disregard and overt harshness for these very ill patients, ultimately harmed others more by not approving Provenge with deliberate intent.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge, and why they have not expanded this approval process to all terminally ill patients remains completely unknown.
What is known is that they are harming those they pledged to protect so long ago by depriving such patients in need of treatment, as no other options are viable presently that are as safe and effective with great tolerability associated with Provenge.
So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others.
A terminally ill patient has a personal right to obtain and access such treatments upon their own volition as well as the discretion of their doctor, just as a terminally ill patient is granted an individual right to die, if they choose to do so. It is an individual decision in such cases that should be void of interference from others.
“Politics is the systematic organization of hatreds.” --- Henry Adams
Dan Abshear
Author’s note: What has been written is based upon information and belief
]]> http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-509688 509688 While it seems plausible that there will be significant off-label > demand from earlier-stage patients, I have doubts about long-term > pricing and competition. The most troubling thing to me about the > data for Provenge is how at the end of the study period, which I > believe was 5 years, there was no difference in survival - in other > words, the Kaplan Meier curves between the treated and placebo groups > merged back together - the same percentage of patients were alive > from both groups at the end of the study. And since I would guess > 75%+ of the patients suffering from prostrate cancer are under Medicare/Medicaid, > pricing will be subject to whatever new rules the Obama administration > is going to push through. Call it rationing or whatever you want, > I question whether the govt is going to be willing to spend $4Billion+ > per year to give a small patient population 4 extra months of survival. > And even if they do, it is only a matter of time before a better > vaccine or treatment comes along - 4 months will not be hard to beat.]]> Tue, 19 May 2009 11:17:20 -0400
On May 18 05:16 PM tredleon wrote:

> While it seems plausible that there will be significant off-label
> demand from earlier-stage patients, I have doubts about long-term
> pricing and competition. The most troubling thing to me about the
> data for Provenge is how at the end of the study period, which I
> believe was 5 years, there was no difference in survival - in other
> words, the Kaplan Meier curves between the treated and placebo groups
> merged back together - the same percentage of patients were alive
> from both groups at the end of the study. And since I would guess
> 75%+ of the patients suffering from prostrate cancer are under Medicare/Medicaid,
> pricing will be subject to whatever new rules the Obama administration
> is going to push through. Call it rationing or whatever you want,
> I question whether the govt is going to be willing to spend $4Billion+
> per year to give a small patient population 4 extra months of survival.
> And even if they do, it is only a matter of time before a better
> vaccine or treatment comes along - 4 months will not be hard to beat.]]> http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-509675 509675 Tue, 19 May 2009 11:11:17 -0400 http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-509657 509657 Tue, 19 May 2009 11:01:49 -0400 www.cancer.gov/cancert...], not the 230,000 you quote. In addition, the observation that 80-85% will become hormone-refractory is grossly wrong. It is estimated that about 1/3 of newly diagnosed patients will fail management of their localized disease. This translates to estimates of 50-60,000 people failing surg and/or radiation therapy yearly and these are the people who may go on to become hormone-refractory--well below your figure of 180,000. I don't know the source of the Merrill Lynch estimate of 140,000 but that is also way off. You indicate that Provenge is given in '2 simple infusions over 3 weeks'--also wrong. It was actually given as 3 infusions every other week. It requires a leukophoresis [white blood cell removal from the patient], shipment of the cells to a processing facility and shipment back to the infusion center followed by the 'simple infusion' you mention. Not a big deal, perhaps, but you ought to get your information correct. Lastly, you comment "we know that the survival advantage over Taxotere, the current standard for metastatic prostate cancer, is a quite robust six weeks." Please tell me where a study was done that compared Provenge to taxotere? The fact is that no such study has been done. I would hope that if you had the 'expertise' to comment on biomedical issues/clinical trials that you should know that you cannot directly compare results of 2 separate studies--that's called a 'historical' comparison but it holds little weight beyond being 'hypothesis-generating'. From my perspective, you've made numerous errors and I have to question whether you are really qualified to draw the conclusions that you do. At least check your facts with someone who knows the field before you put them out to the general public.]]> http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-509100 509100 Mon, 18 May 2009 23:34:00 -0400 http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-509095 509095 Mon, 18 May 2009 23:14:31 -0400
Remember, there are over 2 million men in the US that have had at one point or do currently have prostate cancer. Some do die from other things and some are completely cured, but very many become hormone refractory too. I was using the incidence number to try and figure out some sort of sales estimate. I am sure one can get a different number using the prevalence.
]]> http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-509069 509069 Mon, 18 May 2009 22:46:16 -0400 http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-508884 508884 >Of the 230,000 new prostate cancer patients per year, roughly 80-85% of them will fail hormone therapy at some point.<< That's nonsense. Roughly 80-85% of them never even begin hormone therapy (actually hormone DEPRIVATION therapy) because they are completely cured of their prostate cancer or die of something else before it becomes a problem.]]> Mon, 18 May 2009 18:38:09 -0400 >Of the 230,000 new prostate cancer patients per year, roughly 80-85% of them will fail hormone therapy at some point.<<

That's nonsense. Roughly 80-85% of them never even begin hormone therapy (actually hormone DEPRIVATION therapy) because they are completely cured of their prostate cancer or die of something else before it becomes a problem.]]> http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed#comment-508816 508816 Mon, 18 May 2009 17:16:29 -0400 http://seekingalpha.com/article/72652-amag-pharma-what-s-taking-the-fda-so-long?source=feed#comment-266565 266565 Fri, 26 Sep 2008 22:47:35 -0400
Your article is too optimistic.

FERU will not be approved this fall. It will be pushed back and back and back... more data will be requested by the FDA.

Based on my sources, I am shorting this stock but I'm waiting until the price peaks before the announcement date - around the week before 10/19/08.

For longs, do not try to purchase into AMAG in this environment...you will lose your money...wait until the stock bottoms as it will take longer than expected to puch FERU through.]]> http://seekingalpha.com/article/78913-asco-whose-presentations-look-the-most-promising?source=feed#comment-174575 174575 Tue, 27 May 2008 12:26:17 -0400
Kras data are extremely important since Kras-status will identify cancer patients who will greatly benefit from using EGFr drugs specifically Erbitux from ImClone.

Erbitux is a very expensive drug but it offers to select head & neck, lung and colorectal cancer patients substantial survival benefits, improved quality of life, and for some patients cancer-free survival and even a cure.

Knowing the Kras-status, physicians will be very much eager offering Erbitux to patients who will DEFINITELY benefit from it. This will establish Erbitux as a standard of care for these patients.

This will make Erbitux a mega-blockbuster. Note that Erbitux's worldwide sale is already over $1.5B.]]> http://seekingalpha.com/article/69329-nanosphere-will-be-a-big-winner?source=feed#comment-172282 172282 Thu, 22 May 2008 21:55:18 -0400 http://seekingalpha.com/article/69329-nanosphere-will-be-a-big-winner?source=feed#comment-145957 145957 Sun, 06 Apr 2008 12:10:41 -0400 And what is your motivation? Why are you trying to "save" us from wasting our money investing in NSPH? ]]> http://seekingalpha.com/article/70650-insider-buying-in-biotech-land?source=feed#comment-134806 134806 Tue, 01 Apr 2008 17:57:56 -0400
Suggest you look at SCLN.]]> http://seekingalpha.com/article/69329-nanosphere-will-be-a-big-winner?source=feed#comment-129849 129849 Fri, 21 Mar 2008 13:08:06 -0400
I agree that emphasizing precision is a red flag because there are many things that contribute to precision of a result, including the preparation and handling of samples. Even if the device itself is precise, it doesn't mean the overall result is precise...factors outside of their control are more likely to contribute ot that. ]]> http://seekingalpha.com/article/69329-nanosphere-will-be-a-big-winner?source=feed#comment-129742 129742 Fri, 21 Mar 2008 09:47:30 -0400
Please tell me which company will succeed in point of care molecular diagnostics]]> http://seekingalpha.com/article/69329-nanosphere-will-be-a-big-winner?source=feed#comment-129497 129497 Thu, 20 Mar 2008 17:10:53 -0400 http://seekingalpha.com/article/69329-nanosphere-will-be-a-big-winner?source=feed#comment-129493 129493 Thu, 20 Mar 2008 17:05:05 -0400
Note that the URL's in your first posting were truncated. Can you please re-post them?]]> http://seekingalpha.com/article/69329-nanosphere-will-be-a-big-winner?source=feed#comment-129267 129267 Thu, 20 Mar 2008 10:14:26 -0400
Really?

NOPE!

Funny thing is that the NSPH teschnology is 40-times LESS SENSITIVE than earlier detection methods like PCR!

There are two warfarin genotyping tests that are FDA cleared, one from NSPH and the other from Autogenomics (using PCR). The Autogenomics test is 40-times more sensitive than the NSPH test.

www.fda.gov/cdrh/pdf7/...
www.fda.gov/cdrh/pdf7/...

Did you actually do ANY research at all to verify the veracity of anything you wrote?]]> http://seekingalpha.com/article/69329-nanosphere-will-be-a-big-winner?source=feed#comment-129245 129245 Thu, 20 Mar 2008 09:26:18 -0400
Really? NOPE!

Abbott/Celera has one.
www.accessdata.fda.gov......

Clinical Microsensors has one.
www.accessdata.fda.gov......

Third Wave has one.
www.reuters.com/articl......


"Also, the company is targeting approval of a Respiratory Virus Panel test that can diagnose the flu ready for the 2009 flu season."

Too bad that Luminex and Prodesse have already beaten them to market with respiratory virus panels! And Eragen is submitting one to the FDA this year!

www.accessdata.fda.gov......
www.accessdata.fda.gov......

"The company also hopes to have a test for HPV virus available in 2009"

Really? Funny thing is that HPV tests require a PMA submission with clinical trials that last years in support of the PMA submission! And there is already an FDA-approved HPV tests, plus Roche already has two HPV tests that were submitted tot he FDA last year, and TWTI has two being submitted next month!


"The current troponin tests have to be sent to a lab and sometimes do not get a result for up to 10 hours."

Really? NOPE!

"On average, they reported 90% of myocardial injury marker results in slightly more than 90 minutes measured from the time that those tests were ordered. Among the fastest performing 25% of participants (75th percentile and above), median order-to-report troponin and creatine kinase-MB TATs were equal to 50 and 48.3 minutes or less, respectively. Shorter troponin TATs were associated with performing cardiac marker studies in EDs or other peripheral laboratories compared to (1) performing tests in central hospital laboratories, and (2) having cardiac marker specimens obtained by laboratory rather than by nonlaboratory personnel"

findarticles.com/p/art......
]]>