Biotech Values

[DewDiligence]

>>I'm getting curious about INGN. Something isn't right there. It's my early bet for "Disaster of 2005".<<

INGN may be able to exploit a new FDA procedure called Deferred Accelerated Approval (DAA). This allows a company to file for Accelerated Approval and have the FDA hold the AA application pending the outcome of a separate phase-3 trial that attempts to demonstrate a full-fledged clinical benefit.

If the phase-3 trial hits its endpoints, the DAA is converted to a regular NDA/BLA. On the other hand, if the phase-3 trial misses its endpoints, the FDA is statutorily obligated to ignore the phase-3 results and proceed with the DAA just like a regular AA submission. In other words, the applicant gets to have its cake and eat it too.






























Just kidding, of course!