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Biotech / Medical : Biotech Valuation
CRSP 57.37+0.9%Dec 8 3:59 PM EST
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To: Biomaven who wrote (26539)5/25/2008 1:27:31 PM
From: tuck  Read Replies (1) of 52153
 
Vaguely related to my harpings on the limitations of animal models in drug discovery are IHub's iwfal's (we know him as Clarksterh) musings on the FDA statistical requirements in animal tox studies supportive of NDAs. Just as complicated! I take the liberty of linking the beginning of the discussion here:

siliconinvestor.com

Hit the "replies" links to get the full picture. Seems the only thing you can be sure of is that QTc studies are way quicker than carcinogenicity studies. But the guidelines for the former are based in part on an erroneous statistical assumption -- it's at least an inconsistency with the more solid requirements for human trials. The latter are based on an "acceptable" cancer rate that is arbitrary, like p values, for that matter.

Many thanks to Clark for delving into this issue, one of which biotech investors should be aware.

One important takeaway that Clark also notes is . . . companies need to start their carcinogenicity studies ASAP. It'll take at least two years -- and that's after you hash out the design internally and with the FDA (I would hope this is part of the IND discussions) -- and if something goes wrong you have to start over. What if that something wrong was not a preclinical error (such as the histological artifact that slowed Cortex down last year), but something wrong with drug? If you don't start early, you could be spending big bucks in P3 for a drug with no hope of approval. Having the rat carcinogenicity data come in that late is irresponsibly risky management.

Cheers, Tuck
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