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


To: A.J. Mullen who wrote (10201)1/29/2004 1:53:55 PM
From: Biomaven  Read Replies (1) | Respond to of 52153
 
It should be noted that the FDA doesn't like combination drugs at all. Generally you have to demonstrate improvement over each component separately.

A good example of their attitude is POZN - the FDA insisted on full multi-year tox studies for the combo of two already approved drugs even though there was no hint of any drug interaction. (Both of POZN's important drug candidates are combinations of approved drugs).

Peter