@PearlF Eh gads, Capricor can’t catch a break from these clowns. Ad Com canceled by Prasad because he couldn’t defend his CRL, and now Ad Com required when they hit stat sig in P3 on primary, secondary and all type 1 error controlled endpoints.
@houmanhemmati@FDA So Capricor doesn't get an Ad Comm when it needs one because the FDA doesn't want bad press for a CRL. Now with a Phase 3 that hit stat. sig. on primary, secondary and all type 1 error controlled endpoints, DMD patients have to wait for the FDA to run a dog and pony show.
@HHSGov Right...make the trials easier. And then, when the trial is done, move the goal posts at the whim of the division director. Then, blame the drug sponsor for the fall out.
@realBrandonGill But you are completely OK with the an America that surrenders to Iran and provides them with $300 billion to fund terrorism. Good to know.