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Biotech / Medical : Biotech Valuation

CRSP 56.87

-2.3%

Dec 5 9:30 AM EST

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To: Biomaven who wrote (1807)	10/7/2000 3:31:38 PM
From: smh	Read Replies (1) of 52153

Peter, <...a skeptic could even quarrel with the whole "individualized toxicology" notion. Let's say we can in fact identify the individuals that are at risk from a particular drug. Would the FDA approve a non-breakthrough drug on this basis? I have my doubts that they would in the current environment.> What about the "individualized efficacy" notion? I gather the approval process does not yet allow for pharmacogenomic screening of test subjects. I have no specific example to cite (actually out on a clueless limb here) but presumably there are cases of drugs which may fail (or may have failed) statistical tests of efficacy in the undifferentiated population, but which would be successful under the same criteria in an appropriately targeted subset. It would seem that these issues must be addressed sooner rather than later. Just trying to achieve a rudimentary understanding of what is going on in this area. Comments are welcome. SMH

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