Biotech Values

[poorgradstudent]

Re: Tarceva filing...

Since the FDA's Pilot 1 Program is relatively new (at least to me!), I'm not fully versed in its regulations and guidelines. However, as a I understand it, it guarantees priority review since the FDA is committed to review every part of the NDA within 6 months of receipt. If they had not received priority review, then the review time would have extended past the guidelines of Pilot 1.

My assumption is that the designation of priority review for these Pilot 1 drugs is a mere formality. But I could most certainly be wrong...