Echo To All

Dendreon Holders: Protect Yourself

no sense of panic here. look at my earlier DNDN articles (years ago, after the panel votes). I was one of the originals in the stock prior to the IMPACT study, and speak of caution, not panic, due to experience.

I earned then lost my first small fortune in this stock. Lessons of protection are expensive ones... hope u do not have to experience it.

read the older DNDN articles, and come up with ur own conclusions via content... not via anonymity

(I do not submit articles... SA takes what they want, but my blog is far more trader oriented, via TA and indicators, versus content/opinion on a stock... and SA prefers the latter)

Dendreon: The FDA's Commissioner Doth Protest Too Much!

Been There, you can use the word 'failed' because of poor trial design and lack of understanding the mechanism of action, but the survivablilty aspect of provenge is hard to argue.

also... 13-4 people industry experts basically said it works. And 3 of those 4 were not voting with their head, but instead with their wallets. So yeah... tone down the whole 'failure' argument.

At the very least, this treatment should have been allowed via tight label to those with no other option while the current trial goes forward.

Dendreon: Are the Provenge Prayers Being Answered?

Christian, the FDA is absolutely NOT a market.

You can not use the same measurements for treatments that work differently. It just does not make sense. And this event proves it.

And a revolution in the drug development process is absolutely needed or thousands will die early. period.

Blindly listening to an outdated process, and an organization unwilling to adjust it to a specific circumstance, is what is wrong.

everything stated above is potential pressure so that cowardly organization can recognize its faults and change. allowing at the very least, conditional approval... so the fda "does no harm" to the patients. because right now, the FDA is allowing thousands of men to die early.

the real wrong here, is an organization that allows non-life saving drugs, with potential safety risks to market, while delaying completely safe life saving treatments. AND THEY DESERVE ALL THE PRESSURE IN THE WORLD FOR IT!

Dendreon's Provenge: Is it Over?

thanks for the info hp. And I was never looking for a vast label for Provenge. I was fully expecting a conditional approval with continuous study, and a conservative label (late stage patients not responding or taking tax.). I thought I was being realistic with my expectations.

As for me, I do not think I will be long another biotech for a while... this whole situation left a bad taste in my mouth. (the only way i will go long is if one of the small biotechs I follow hits unusually low stock price due to sector weakness or something)

I truly lost a lot of trust in the process and the FDA in general.

A Lost Hope? Dendreon Derailed While Archaic FDA Promises 'New Era'

nice article. My anger over the FDA, and its ambiguity does not permit me to be so elegant.

The FDA owes the cancer patients (they deprived of hope) a HUGE explination. And it better be fricken good.

It better be more logical than... allowing a treatment that is COMPLETELY safey, that shows substancial evidence of efficacy and that is specific for a patient population that has no other form of treatment available to them. (Either Tax. will not work for these patients or they refuse it due to the quality of life issue.)

They better be able to explain the "risks" of provenge toward this patient population for the delay, when these patients have NO OTHER OPTIONS. They better be able to explain how they (the FDA) are doing these hopeless patients NO HARM!

The FDA has a LOT of explaining to do, and congress better force them to explain, ASAP. And the FDA better have a pretty good fricken reason.

Dendreon Decision Harms Cancer Patients and Stockholders

Honorable actions to give your profits like that. The FDA seems so lacking in credibility now. If they always knew they were going to ask for more efficacy data on Provenge why not be harsher in the briefing documents? Why not allow the question as initially incorrectly stated in the AC meeting? (This way the efficacy aspect would have meshed with their reason for delay)

Instead the FDA is now in the position to justify why they are delaying a treatment that was voted 17-0 for safety and 13-4 on efficacy.

If I were a senator, I would love to know why are delaying something with such an overwhelming support from the AC... and ZERO safety risk.

Are Hedge Funds a Risk to the System? The Proof is in the Provenge

Amit,

"What kind of prime broker will let a fund manager ride out a $4 short up to $20+ or wherever it hit during that phase?"

there really was no choice, the stock moved up to 15 as soon as it started trading from being halted during the AC meeting.

Buffett, i am sure would not, at least to what I know of his trades, put 30% concentration of a portfolio in a seasonal trade hoping for a hurricane to occur. But he would in an entity with a clear durable competitive advantage. Then again, that is the difference between a 30% concentrated speculative play verse a 30% concentrated investment.


biomund,

"A hedge fund investor has a right to know what the degree of concentration and corresponding risk is before making an informed decision"

forgive my ignorance (but i'm not in the biz), but can't investors ask, and if they are not satisfied with the answer, simply walk away and go to a fund that does provide such info?

I do not think it is wrong to have standards as an investor before investing in a management. does not mean you need regulation.


all,

thanks for the comments.

Clarifying the Issues Surrounding Dendreon's Provenge

well done... very well done.

ODAC Member Raises Concerns About Dendreon's Provenge

When I first heard this letter was out I got pretty angry. The reason I got angry is because this person has dedicated their life (or current chapter of life) to save people's lives (or at least I am assuming that is the case), and yet is turning away a treatment that the AC panel deems EXTREMELY safe and has substantial efficacy.

This person is a leader in the field (at least to someone outside the cancer community), and has the responsibility to NOT be overwhelmed by one side vs the other. Why is it so difficult to see the middle of the road here? I just do not get it.

Where is the risk to which drives the inability to adapt at least in a half way point?!? WHERE?!?

Provenge shows NO risk to the patient, NONE. On top of that, after the infusions, chemo can be applied (if the patient desires it). Also, the point is not about Provenge VS Chemo, but about choice to the patient.

If there was a risk to taking Provenge the letter like this would be justified and I would agree completely, but we can not just close our eyes to the most beneficial path (for PC patients) because someone's opinion does not agree with the facts. The PC patients do not deserve such ignorance.

(The most beneficial path may very well be a combo of Provenge w/Tax... why deny this option to the patients by denying Provenge when Tax obviously holds the greater risk... WHY?)

Dendreon: Don't Forget About Risk vs. Reward

Risks to reward? I have written a piece painting the realistic risk, and it is minimal. You say you are optimistic, yet you make comments like this:

"While I acknowledge the FDA typically follows the panel's recommendation, I would find it surprising if the FDA did so in this case."

You are kidding, right?

You also mention... "For some reason, the FDA reworded the original question." That should tell you something about the FDA, and CBER. If it doesn't, then I don't know how to spell it out for you any clearer.

The stock's conservative value is around 30, w/ a ROW it is around 40. (And that is on Provenge alone, excluding the potential of the underlining Cassette Technology applied to other cancers. Which is already proven via Neuvenge for certain breast cancers.) The stock has been artificially held down for 2-3 YEARS, and you call its current movement crazy? I call its capping crazy. DNDN should never have been at 3-5 before the AC meeting. The downward pressure created this craziness, and now DNDN is merely going to where it should be.

(PS... because of all the shorting interest, and lack of sellers, it will go higher than 40 upon approval. Any one still short should keep Suppy and Demand in mind. The real risk is on the short side.)

Update on Dendreon's Briefing Docs: Provenge Missed All Endpoints

maxim, your twist on the safety data is wrong.

u simply show that patients unfortunately died w/ CVA from the provenge arm and not placebo, but Dan rightfully pointed out that in the placebo arm a few patients experienced CVA also.

all that can be said for the CVA issue is that it was experienced in both areas, but no one from the placebo arm died.

it is something to look into, obviously, but as per the results from the placebo arm, the CVA does not deserve much negative focus.

The Short Case on Dendreon Corporation

Mark, the premise of your argument... "there is no clear evidence that the drug actually works" is questionable. as walldriver has shown. (and he is more qualified to debate the efficacy argument than I... far more qualified)

But the logical premise, in my layman eyes, is the fact that people are dying. And there is enough information out there that UNQUESTIONABLY proves the safety of this treatment, along with a very high likely of efficacy. But your statisical argument remains, and has allowed this stock to get punished (or manipulated... whatever word you like to use) on the downside for far too long.

the question any long or short should aske themselves is this... Why would the FDA delay a treatment if there is absolutely NO safety risk with a drug that has shown to increase survivability to a population that is medically underserved?

More information can come out during the committee meeting, that may prove one side correct over the other. But the inforamtion we have now does NOT merit DNDN to have been at 3.68 a few days ago.