“The FDA’s accelerated approval pathway allows it to permit the sale of therapies for serious conditions based on early clinical data that suggest they are probably effective. If SRP-9001 is given accelerated approval, the therapy’s developers (Sarepta and Roche) would be required to conduct additional testing to prove its clinical effectiveness. The company did not specify which data will be included in the upcoming BLA.”
Boomy!
FDA approval still needs All 3 Sarepta drugs to show efficacy:
This hurts you Boomy
Atl1102 will work with all 3 drugs re inflammation
for a better result..
$5 in time
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