Biotech Values

[tinkershaw]

The other interpretation if you read the language directly is that a Phase 3 trial will be necessary, but that will not preclude the FDA from giving regulatory approval based upon the 2b data, as long as VRTX runs a concurrent Phase 3 trial. Which is exactly what ELN is doing with AAB-001.

Would this not be a Reg-E filing? I am not an FDA legal expert by any means. But at least from a reading of the press release language, it may only be worded that way to indicate that a Phase 3 trial will be run no matter what, but the running of a phase 3 may only be a condition towards receiving marketing approval based upon the Prove 3 study.

So in the end, it may not mean anything, unless of course the FDA is totally broken, which many might just concede it is.

I think the timing of the 107 release as to how close it is until VRTX submitted data to the FDA on Prove 3 is the best evidence that we have that the Prove 3 data was positive and consistent with the 107 data. Not to reveal negative information after releasing preliminary data like 107 would clearly be actionable in a civil case, and I think it would border on criminal not to do so. So one has to feel somewhat confident that the Prove 3 data is at least consistent with the 107 data given the very close timing of the 107 release with VRTX having to know the results of Prove 3.

Tinker