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

To: Spekulatius who wrote (2543)	1/11/2001 10:02:52 PM
From: rkrw	Respond to of 52153

<<<The other problem is that this of course does reduce the cleanliness of the trial since its sort of trying again and again, so hopefully this has been signed off by the FDA.>>> This was a predesigned option agreed to with FDA before the CARISA trial began, according to CV.

To: Spekulatius who wrote (2543)	1/12/2001 9:41:05 AM
From: Biomaven	Read Replies (1) \| Respond to of 52153

Spekulatius, The other problem is that this of course does reduce the cleanliness of the trial since its sort of trying again and again, so hopefully this has been signed off by the FDA. No, this is not a "sort of trying again." This is very different from taking an early look at the data and then deciding to increase the trial size based on what you see. That rightly causes a hit, whereas what they did does not. All they did was look at the variance of the end-point in the combined placebo+drug group. As RKRW said, this was pre-approved by the FDA and part of the original trial design. In general, biotech Phase III's are smaller than pharma Phase III's, which increases the risk of a false negative. IMO, it would be smart for more biotech trials to make use of this provision that allows an early look at the variance. Peter