Repros Therapeutics, Inc. (RPRX)

[steveporsche]

Seems like you were making some cultist arguments to Andy here:

Author: akasidney86 send pm · add member to favs · ignore · recommend


Recs: 139 My email to Andy
Dr. von Eschenbach:

Your decision regarding Provenge is an unmitigated disaster on so many levels:

1. Biotech funding: this will further reduce funding of biotech, arguably the major component, within a free-market economy, of new solutions to very complex health problems.

2. Status of the FDA within the world medical community: it makes you personally and the office of the Director of the FDA a person/position of zero credibility given your repeated comments about the 'new, bridge-building FDA', and thus hurts patients around the world who look towards the U.S. and the FDA for leadership.

3. New medical thinking and breakthroughs: it encourages the obvious, deliterious and widely commented predatory tactics practiced by the hedge fund community of shorting and pressuring developmental biotechs... with only one outcome... fewer successful drugs on the market.

4. Effect on internal FDA policy; It strengthens those who would serve and who live off of Big Pharma and the money it generates, while weakening those who would, while respecting to the letter the stated policy of the FDA, offer a pathway to approval for drugs in terminal disease applications.

5. The effect on patients suffering terminal diseases: it states that, from the FDA's point of view, there is no difference between a potentially lifesaving treatment and a toe fungus medicine... terrible news for all those who need hope in a desperate struggle.

6. The question of the risk<>benefit relationshipand it's current meaning within the FDA: This treatment was turned down in spite of a panel which unanimously stated that it carries no health risk. Therefore, how possibly can the risk/reward ratio be negative if there is no risk and clear reward.

7. The FDA approval process as a whole: as there was no new information disclosed through the FDA vetting process, that can only mean that the information that the FDA denied the BLA on was exactly the same information that it allowed Dendreon to file under. What is the point of that?

8. The importance and viability of the Advisory Committee process: the BLA was voted by the most prestigious authorities the FDA itself could find safe and eficacious... and then ignored. This can only hurt this vital process, the only part of the process actually open to the people that the FDA is supposed to be serving, the public.

9. The importance of patients and patient advocates within the FDA approval process: All of the recognized Prostate Cancer groups supported the Provenge BLA... and were ignored. The FACT that Dr. Maha Hussain actually fell asleep during the disregarded Advisory Committee meeting speaks volumes.

For these reasons and many, many more, your decision to deny the Provenge BLA is simply unconscionable, and we the people will pay the price for many, many years to come.

signed xxxxx

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