Dang thing would not let me edit my post.
In any event, we now that the Prove 3 data is robust enough to enable start of Phase 3 even prior to having all the Prove 3 data in hand.
We also know that VRTX is rather confident (if not absolutely certain) that Prove 3 itself will not be sufficient for use for early registration.
And as an aside, that is ridiculous, but it is my opinion that unless the FDA pushes VRTX to make the application, that VRTX is not holding out much hope, nor have much enthusiasm to do so itself.
Disappointing to say the least, as really the only inference that can be made reading between the lines is that the Prove 3 data was decently robust. There was no such ambiguity left regarding the possibility of using it for early filing and registration with the FDA as one might expect in a situation like this.
Tinker
