RE:RE:FDA guides on how AA can be converted to full approval. Further to this, a typical Phase III registration study is 800-850 patitients.
When ONC receieved the FDA's letter of Special Protocal back around 2016, that letter cut the mBC Phase III required patients to 400-450 patients.
At that time, ONC recieved aditional advise on Phase II reported data from the FDA. Basically stating, there appears to be a pattern in the data that may suggest a biomarker, but the trial was not set up to capture the biomarker data. So it could not be used. The FDA noted that if a biomarker was determined the FDA would cut the Phase III mBC down in half again to around 225-250 patients.
Go back and read the NRs, these comments are all in the ONC historical NRs,
Thus AWARE-1 and BRACELET-1 were developed, to determine a biomarker, and those trials further developed along the way.
Throughout the two trials, ONC noted the think they may have identified not just one, but two biomarkers.
So... if MC is now stating the Phase III mBC will be 200-300 paitents, IMHO MC has seemingly informed us that the biomarkers have been confirmed and the FDA has indicated the will cut the patient requirements as previously discussed.
On another note, IMHO, I am not expecting any news now until the major media event in June. I think it is going to be quiet.
I am also still considering that we may see a PP after the big reveal. MC even noted in a recent pod cast, that they have not ruled out a PP. Not sure if that is smoke and mirrors for BP's attention to state ONC is not despatate to accept low bids, but based on other comments regarding letting the data mature out 2024, I see it as one possibility allowing ONC the start Phase III trials in H2 2023 as previously suggested by MC.
I don't want a PP. I hope ONC sets a deadline for bids as suggested herein.
I want a buyout by August 2023, IMHO that would be best for us longs.