<<<Are the PROVE-3 data that VRTX has seen less than stellar? Or is the above language merely boilerplate conservatism? I’m not sure.>>>
If this is boilerplate conservatism, it is very conservative. The 10Q could have stated that we have submitted the data, we are in discussions with the FDA to obtain regulatory approval based upon this data, there is no guarantee such approval on phase 2 data will or can be obtained from the FDA who wouldn't approve aspirin today with less than 15 years of clinical study. As such we have also submitted a phase 3 trial design to the FDA if the FDA does not enable registration from the phase 2b data, and in such case it will be necessary to conduct a Phase 3 clinical trial in order to obtain regulatory approval.
Language like that, which is still conservative, but which gives more information, would have been perfectly fine and appropriate and unless VRTX understands and has information that there is no way the FDA will even consider regulatory approval based solely upon phase 2b.
If I were VRTX I'd file anyways, and let the FDA come forward with information that (1) there is not enough evidence that the drug works as indicated (despite at least 3 well controlled clinical trials), and (2) there is not enough evidence that the drug is reasonably safe (despite the reasonably large and growing safety database).
If the Prove 3 data is good and the FDA will not even consider approval on this, then the FDA is really broken, and not just broken in the sense that people poke fun at it, but legitimately cracked and broken.
The language in the 10Q would imply that the FDA is broken, unless the Prove 3 data was not so stellar. In which case, VRTX may be in trouble because they released the 107 data on April 24, implyng that the Prove 3 data would be similar. If VRTX was unblinded to the Prove 3 data when they released the 107 data just a month ago, and the Prove 3 data is decidedly not consistent with the 107 data, that would be a big time issue of stock fraud. It is hard to believe VRTX did not have a good idea how Prove 3 was going as late as April 24.
So it would be difficult to think VRTX would do this, as they had to have some idea as to how Prove 3 was gong at the time they released the 107 data if Prove 3 data was not positive. So Prove 3 probably has good to decent data. Which would mean it is at the FDA's feet and they are broken if they have communicated to VRTX that they will not even consider approval based upon Phase 2b, no matter the result.
Wonder how this may impact a stock like say ELN that is running on the hope their Phase 2 study for AAB-001 can be used for registration despite an on-going phase 3.
Tinker
AI
