Dendreon Bulls Not a Cult, but Wild Optimists
by Michael Shulman
BiotechBlitz
The Dendrreon (DNDN) bulls are not exactly a cult. Cult is not the right word -- I would say they are an unreasonably large number of wild optimists who love the stock they own, always a dangerous thing.
A little history for new readers.
In my paid service I recommended DNDN for several years and said they would get an FDA panel approval. Only the folks at Biotech Stock Research and Sagient Research agreed, no one on Wall Street did. The panel meeting was held, it was almost unseemly as both DNDN and the FDA broke records for incompetence and Provenge, DNDN's treatment for prostate cancer, was approved. I immediately told my subs to hedge or take profits becuase the nature of the panel decision put the final approval at risk. The final decision was negative -- the FDA overturned the panel -- and then the fun started.
Many people hung on to DNDN when it went from $4 to $24 and back to around $6 or $7. I believe the stock is worth about $2, because I do not believe the early results from the current trials will generate an approval.
So far -- just as before -- I'm in the minority and the stock is holding up to near where it first landed after the FDA reversal. There is not enough space or time here to explain why I think the new, early trial data will fail to get them an approval. I do believe if the company were managed by adults, which it is not, DNDN would forego an early shot at approval and would ultimately get approval in 2010 or 2011.
Part of the tragedy generating the ongoing publicity is from those people who are aware of patients dying early or needlessly because of the FDA decision and the attempts to reverse the decision through political means.
A reversal will not happen -- and better not happen unless you want Congress, and therefore lobbyists, making decisions on which drugs will or will not work! That being said, the cowardice and incompetence of the FDA staff -- in particular the oncology gods at CDER and the statisticians -- are killing more men earlier and/or needlessly in a month, than we're losing in Iraq in a year, if Provenge does work for even a small percentage of prostate cancer patients.
And everyone agrees even if Provenge does not work it does no harm. Hormone refractory, late-stage prostate cancer is one of the meanest deaths on the planet.
What were the FDA bureaucrats thinking when they said no after the panel agreed unanimously (and strongly) that the treatment was safe?
I hope this helps.
For purposes of disclosure, I still own DNDN as I sold January, 2009 $7.50 calls as part of a hedge after the FDA panel decision.
RELATED READING:
- Dendreon: Media's Hype and Hope!
- Dendreon Deservingly Jumps on New Cancer Vaccine Report
- Options Expiration Weighing on Dendreon
- Cell Genesys Should Not Trade With Dendreon!
BiotechBlitz is a regular contributor to BioHealth Investor
______________
BiotechBlitz
The Dendrreon (DNDN) bulls are not exactly a cult. Cult is not the right word -- I would say they are an unreasonably large number of wild optimists who love the stock they own, always a dangerous thing.
A little history for new readers.
In my paid service I recommended DNDN for several years and said they would get an FDA panel approval. Only the folks at Biotech Stock Research and Sagient Research agreed, no one on Wall Street did. The panel meeting was held, it was almost unseemly as both DNDN and the FDA broke records for incompetence and Provenge, DNDN's treatment for prostate cancer, was approved. I immediately told my subs to hedge or take profits becuase the nature of the panel decision put the final approval at risk. The final decision was negative -- the FDA overturned the panel -- and then the fun started.
Many people hung on to DNDN when it went from $4 to $24 and back to around $6 or $7. I believe the stock is worth about $2, because I do not believe the early results from the current trials will generate an approval.
So far -- just as before -- I'm in the minority and the stock is holding up to near where it first landed after the FDA reversal. There is not enough space or time here to explain why I think the new, early trial data will fail to get them an approval. I do believe if the company were managed by adults, which it is not, DNDN would forego an early shot at approval and would ultimately get approval in 2010 or 2011.
Part of the tragedy generating the ongoing publicity is from those people who are aware of patients dying early or needlessly because of the FDA decision and the attempts to reverse the decision through political means.
A reversal will not happen -- and better not happen unless you want Congress, and therefore lobbyists, making decisions on which drugs will or will not work! That being said, the cowardice and incompetence of the FDA staff -- in particular the oncology gods at CDER and the statisticians -- are killing more men earlier and/or needlessly in a month, than we're losing in Iraq in a year, if Provenge does work for even a small percentage of prostate cancer patients.
And everyone agrees even if Provenge does not work it does no harm. Hormone refractory, late-stage prostate cancer is one of the meanest deaths on the planet.
What were the FDA bureaucrats thinking when they said no after the panel agreed unanimously (and strongly) that the treatment was safe?
I hope this helps.
For purposes of disclosure, I still own DNDN as I sold January, 2009 $7.50 calls as part of a hedge after the FDA panel decision.
RELATED READING:
- Dendreon: Media's Hype and Hope!
- Dendreon Deservingly Jumps on New Cancer Vaccine Report
- Options Expiration Weighing on Dendreon
- Cell Genesys Should Not Trade With Dendreon!
BiotechBlitz is a regular contributor to BioHealth Investor
______________
posted by Nico at
5:55 PM
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