Replies to post #44944 on Biotech Values

[lumpy9200]

bladerunner,

I honestly respect your opinion, but I simply have to disagree. You say you don't know what I mean by "biggest risk", but what you posed was that Von E. can't risk the NY Times headline that he went against Scher's recommendation. If Von E. needs to "present a united front", than he will side on the 13-4 AC vote, not side with one of the 4 no's who happened to write a letter confirming his no vote.

Would it be more compelling if one of the "yes" votes had written an open letter begging for Provenge to be approved?
I think that would have looked silly.

A "turf war" within the FDA is bad, I agree, but that's Pazdur's problem. He stands to lose, IMHO. The Democrats opposed Von E. until he signed off on Plan B, but that's done. I don't think Von E. has to worry about congress at this point. Denying Provenge after the AC vote will be a difficult explanation to the press, regardless of any ambiguity in the data. Surely you saw every news channel on the weekend following the vote talking about the "cancer vaccine". Every reader of Biotech Values probably knows what a cancer vaccine actually is, but what about those who don't follow biotechs/pharma. To most, a cancer vaccine is like the chicken pox vaccine: Gimme a shot and I won't get cancer. We know this isn't true, but makes for a much tougher NY Times headline if they don't approve. Personally, I don't think Von E. or anyone else (except perhaps Scher) is worried about headlines.

I find that statement to be rather naive. With all due respect to the very, very, very erudite science-types posting here--and with a "hats off" to them for the lively and intelligent discussion here--the decision is no longer a scientific one; it is a purely political one.

While it is very possible that I'm naive, your comment that this is now purely political smacks of IVillage in reverse. I generally do not believe in conspiracy theories. ODAC seems to insist that primary endpoints are met, CBER open to other data. This bodes poorly for DORB, which I own a lot of, but should have no bearing on those who will decide Provenge's fate.

Bladerunner, would you insist that an AIPC patient take Taxotere or nothing? Even Dr. Hussain has spoken out against Taxotere, although she forgot that at the AC meeting. Wait, did I say I wasn't a conspiracy theorist?

Joking there, but to be serious: The AC panel knew EXACTLY what they were voting on. These are experienced doctors, not Charles Barkley (I was misquoted in my autobiography).

As someone previously stated, I guess this is what makes a market.

Have a great weekend,
Geoff

[donotknowityet]

Von E's biggest risk is not any article in the New York Times, but a recurrence of his prostate cancer.

[stuck_holder]

Any sign of a "turf war" within the FDA, especially regarding oncology, would be a bad signal to send to Congress at this point.

i think you are overestimating ODAC & Pazdur's hand when it comes to their apparent internal battle with CBER & Provenge, & how that might look to Congress.

Last time i checked, the Democrat's black caucus is pretty influential when it comes to matters that directly & disproportionately affect their constituents, and the greater incidence of prostate cancer among black men is (or should be) well known to this group.

frankly, i would welcome ODAC & Pazdur creating a turf war based on whether the FDA's decision to approve Provenge is justified, since it would draw deserved attention to ODAC's, and in particular, Scher's conflicted position and Pazdur's apparent not-so-hidden agenda.

While i suppose some in the black caucus could be bought off (as with any politician), i think Pazdur would meet his comeuppance if he really wants to push the issue of Provenge approval into a public & political debate...

in fact, close public scrutiny of this issue, imo, would help serve to clean up the FDA & ODAC in particular, something that appears to be desperately needed based on my layman's read of this situation.

[Jonathan Robinson]

The easiest thing to do is to allow it be used but to throw it back on the company through CU program - "see, we listened to AC but also guaranteed trials would be finished given results to date."

The political answer is approvable with CU. It may be inconvenient to longs and to the bio sector as a whole, but I think I agree with Dew that that is what is coming. It is the perfect solution to a thorny political problem. If it does not get used in a CU, it is DNDN's fault for having poor finances.

Jon