Biotech Values

[DewDiligence]

>>Assuming Xinlay is approved, would it continue in trials to try and prove efficacy, or would doctors just be expected to prescibe it in perpetuity based soley on bioactivity?<<

I can’t tell if you’re being serious or facetious, so I’ll assume serious. If Xinlay gets Subpart H Accelerated Approval (what people on the GENR board naïvely think Evizon will get in AMD), then Xinlay will presumably have to show bona fide efficacy in post-marketing studies to remain on the market and avert an Iressa-like demise.

On the other hand, if Xinlay gets full (not accelerated) approval, ABT is all set—the FDA would not then be able to rescind approval unless some major new safety problem arose.