Legit, I hope MSB gets the approval this time.
Maybe the FDA has changed its mind and decided it was purely the potency assay that was the issue.
The reason I'm skeptical is because less than a year ago, when the second CRL was issued, MSB said it would address the issues raised by performing another trial in adults in order to gather more evidence.
That has slowly morphed into just needing a potency assay. Without management explicitly saying that the FDA only requires this
After the first CRL, MSB said the FDA requested a further RCT for more evidence.
That then morphed into drudging through post hoc analysis, etc, and they reapplied a second time, and everyone was certain it would be enough.
Including Si.
I hope I'm wrong this time.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-257
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