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Re: i760 post# 982

Monday, 09/11/2006 11:53:14 PM

Monday, September 11, 2006 11:53:14 PM

Post# of 12660
>Should you fail to provide an example, I can't help wonder if your view on this topic is just another example of hot air.<

LMAO

The July thread on InvestorVillage started by Ocyan was about the Coreg case, specifically, and that’s what I’ve been talking about on this board in the past few posts.

To reiterate, what happened with Coreg is the exception, not the rule. Any of dozens of cancer trials where overall survival is the primary endpoint is proof that sponsors did not expect to receive the benefit given in the Coreg case. If they had, obviously these sponsors would have made overall survival a secondary endpoint in order to take 0.05 of p-value for some other primary endpoint (TTP, PFS, or what have you) while still retaining a full 0.05 of p-value for overall survival as well.

Your latest question about divvying up p-values is superfluous to the above discussion.

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More important, this entire discussion is academic vis-à-vis the Provenge BLA, in my opinion. I’ve posted that overall survival being a secondary endpoint rather than a primary endpoint is not the reason I expect Provenge to get an approvable letter on the first review cycle. Rather, the reason I expect Provenge to get an approvable letter on the first review cycle is that 9902a was not genuinely supportive of 9901, and 9901 was obviously insufficient for approval on its own. This is what will become painfully clear to DNDN longs the day before ODAC when the FDA’s briefing documents are published.

Good luck with your DNDN investment. Out.

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