Aug. 19 at 1:24 AM
$SLS If you want an inkling of the cataclysmic PR disaster that the FDA will endure if by some slim chance the FDA fails to completely approve either GPS or 009 due to some arcane statistical issue, look no further than the recent
$REPL uproar that completely embarassed and exposed the FDA.
The original committee voted for FULL APPROVAL. Frontline treating doctors COULD NOT BELIEVE that REPL even received 1 CRL, then at the 2nd CRL the entire melanoma trial crowd went ballistic. The WSJ crucified the FDA for their decisions. REPL had trial patients who, without REPL, would have died, but instead survived and went into COMPLETE remission. Embarassed, the FDA recently backtracked and granted ACCELERATED APPROVAL.
Like REPL, SLS has terminal patients on GPS who would BE DEAD NOW if it weren't for GPS. There is NO WAY the FDA says no to GPS, especially after approving Expanded Access and Infinite Dosing.
imo, at this point, there is a 99.99% chance GPS success and approval based on the science.
