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Replies to #90921 on Biotech Values
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DewDiligence

02/21/10 6:29 PM

#90928 RE: hmpa #90921

Except for "politically sensitive" situations (Lovenox/m-Enoxaparin being the prime example, and we are not talking lack of budget here), FDA almost never delays first few ANDAs for a particular drug - whose launch results in a major price drop.

Inasmuch as ANDA’s do not have proscribed review timelines, it’s not clear exactly what constitutes a “delay.” To make your argument, you need to show hard data on the review times of first-filer ANDA’s vs ANDA’s in general. If you have such data at your fingertips, please post it. T.i.a. Dew