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
Market Data 
Markets 
AI
