I'm convinced (by the FDA guidelines for accelerated approval) that MRNA and MRK are trying to get FDA to accept a BLA application for accelerated approval of Keytruda+4157 for resected melanoma while the "confirmatory" P3 trial is under way. This includes FDA's approval of P3 trial design and size.

 

If I am correct, the announcement will be the acceptance by FDA of P2 results for accelerated conditional approval consideration and commencement of the P3 trial.

 

Such an announcement would mean this treatment could be marketed several years before a BLA application with P3 results. If it happens, stand aside for the price explosion.

 

Trusting government the way I don't, It would not surprise me that some people inside FDA, CDC, NIH with sufficient knowledge to smell such market moving news coming would leak some tips. So watch Pelosi's husband's trades carefully.