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Biotech / Medical : Biotech Valuation
CRSP 56.68-2.4%Dec 12 9:30 AM EST
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To: Icebrg who wrote (13570)10/28/2004 2:52:07 PM
From: kenhott  Read Replies (1) 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.
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