Biotech Values

[DewDiligence]

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