History101
Oct 11, 5:44 PM
$SLS imo GPS approval from the FDA is already in the bag.
However, can you imagine the outrage from the entire leukemia community, especially the world reknowned AML doctors who are overseeing the GPS trials, and the frontline docs treating the patients, the doctors who have advocated for (and received) infinite dosing and expanded access, if GPS is not approved??
imo the reaction from the AML community would be 10x the outrage that occurred with the
$REPL community when REPL got their unexpected CRLs.
Even if the efficacy stats are close, which they won't be (GPS will blow the stats out of the water), imo GPS gets approval based on TOLERABILITY ALONE. A large % of CR2 AML patients choose death rather than the extremely toxic and painful BAT.
GLTALs!!
1 replies