“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 stop being sooooo angry
Read the above again :
“would be required to conduct additional testing to prove it’s clinical effectiveness( efficacy in other words)
$5 in time
For General Information, page-1113
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