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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (13570)	10/28/2004 12:31:13 PM
From: scaram(o)uche	Respond to of 52153

Cool. Thanks. Any mention of when we can see survival curves?

To: Icebrg who wrote (13570)	10/28/2004 1:05:17 PM
From: Biomaven	Read Replies (2) \| Respond to of 52153

they have reached statistical significance in the overall intent-to-treat population. Yes - this was the possibility I mentioned yesterday as a long shot. Clearly they have some long-term survivors in the treated population - the fact that they reached significance only when they went to 36 months likely means it's some long-term survival that's driving their results. Peter

To: Icebrg who wrote (13570)	10/28/2004 2:52:07 PM
From: kenhott	Read Replies (1) \| Respond to of 52153

I am fairly new to DNDN but I did listen to the conference call. And I would say it is worth a listen if you have a horse in the race, or maybe even if you do not. It is about 30 minutes, less if you go to the Q&A directly. First a question. Does anyone know of a later phase cancer trial in a smiliar stage of disease that showed p<05 for "# of survivors" vs placebo or vs a comparator? After listening to the call, I have to think that Iceberg (ahh Mr. Iceberg?) is right that the driver of ITT survival has mostly to do with the gleason <7 patients. I am guessing that N was 3 to 2 for gleason <7 vs. >7. That would say that the <7 sub-group kicked some serious cancer ass. But the survival advantage at least in terms of pure numbers is suppose to have been somewhat indepedent of gleason. And the number of "final" survivors is suppose to have been "significantly more or some such words" than placebo. Of course there was a crossover in the trial so I am not exactly sure how they are counting their numbers. At 36 months, there were significantly more (So not just a couple of long survivors) patients standing from the drug arm than the placebo arm. ITT survival p was significant. The FDA has to look double hard at just these facts for this indication. FDA can of course do whatever they want but unless there is lying, fudging, stupidity, etc., going on here, I say DNDN has a drug sooner rather than later. But since I don't have the history, maybe I am missing something.