Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-266

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. CRL wanted potency assay data - they did not change their mind.

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. Or come up with data that answered the CRL

That has slowly morphed into just needing a potency assay. Without management explicitly saying that the FDA only requires this Incorrect- in fact the company was explicit in detailing the requirements of the FDA, also stating that efficacy was not an issue- repeat- efficacy is accepted by the FDA


After the first CRL, MSB said the FDA requested a further RCT for more evidence. Yes- in either kids or adults OR provide potency assay data in place during the 001 trial that can prove potency of todays stock on the shelf.

That then morphed into drudging through post hoc analysis, etc, and they reapplied a second time, and everyone was certain it would be enough. No - that morphed into several months of correlating data that had not been presented to the FDA- data from the 001 clinical trial

Including Si.

I hope I'm wrong this time. I've highlighted in purple your descriptions that negate your wish for a positive outcome


Hey Doc - now that manufacturing, safety, efficacy are ticked off and the FDA have just liked the look of the new potency assay data- are you still a sell?