Sarepta Therapeutics (SRPT)

[Schmiggins]

Vinny Prasad ragging on Sarepta with Adam Fuerstein of all haters?!
StatNew Headline:

"Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says
Remarks suggest license for Elevidys could be revoked over safety concerns"


..."Sarepta Therapeutics, the maker of a gene therapy for Duchenne muscular dystrophy that is being temporarily shelved because of safety concerns, faces an “arduous and treacherous path” to try to get it back onto the market, a senior Food and Drug Administration official told STAT, suggesting the treatment’s license could be revoked.

The official, who spoke to STAT on condition of anonymity, did not rule out the possibility that the therapy, Elevidys, could eventually be brought back on the market. But it would be difficult for Sarepta to prove that any new safety protocols could eliminate the risk of liver injuries — which have been tied to the deaths of two patients — the official added.

“How do you show something is safe when it’s already proven to be not safe?” the official said."

Wow. So he's already said "it's been proven to be not safe". Even though 900 kids got it with only 2 recent deaths in a trial for older, heavier, higher dosed boys. This guy is crazy. Irresponsible, biased and needs to get thrown to the curb fast.