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Re: walk post# 2589

Saturday, 03/31/2007 12:36:38 PM

Saturday, March 31, 2007 12:36:38 PM

Post# of 12660
Excellent point regarding biostat guy's refusal to quantify the liklihood of a false positive.

I was equally dismayed and simply confounded when I heard his response. He basically left any of the less statistically proficient panel member (most of them) completely in the dark. From his response one could have derived that there was no better than a coins flip chance of the efficacy data being reliable.

That answer was devestating, and seemingly intentional. What was just as damning was DNDN not quickly disputing that answer. He could have easily indicated that maybe it wasn't cut and dry....but then gone on to explained that a reasonable guesstimate would have been the "1 chance in 40" estimate (or whatever) and how it was derived.

As you said....I think he knew what the likely chance was, as it had been alluded to in the briefing docks. I have to conclude thus, that it was intentional.

I hope von E. and others in FDA have placed a big question mark by this guy's name in regards to being trustworthy and competent.

BTW I am surprised that a bigger deal hasn't been made of this. I would have thought Ocyan would have been all over that item....has anyone even heard from Ocyan since the panel?

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