banter and General Discussion, page-10181

@reginaldp

Yes, in my opinion, you are in denial.

Your post quotes Hoffman from 2020. There has been two CRLs since then. Also since then Eric Rose said (I think it was May 2022 and so ahead of the second BLA submission) the potency assay had problems.

You've taken a single sentence from Hoffman who himself says in the second sentence you quote "The morning session had a lot of science in it that many of us clinicians are not familiar with" I think out of its relevant time and context.

Yes the sentence explains his vote at the time - but he didn't at ODAC have the benefit of Eric Rose acknowledging the potency assay has problems. Silviu was not describing a potency assay with problems still he was describing a potency assay that had been improved.


The FDA though knew that, they were pointing out inconsistencies in what MSB had in their briefing which the ODAC panel saw and what they had seen - they'd seen more than was in the ODAC briefing.

The FDA reviewers (not the ODAC who did get persuaded by Kurtzberg) would not have been doing their job if they'd got swept away with those emotional arguments and not held firm on the need for evidence that the product actually would work (in future when the same donors couldn't donate) based on the potency assay (in particular and not something else) being associated with better than expected (if they'd been untreated) patient outcomes.