On top of your analysis, I don’t think you can understate the potency assay work collegiately done with OTAT. What we do know is the Blast are hell-bent on getting kids approved with an adult trial post approval. Therefore they wouldn’t propose a new potency assay to measure in vitro and in vivo that they haven’t been able to retrospectively and concurrently measure for batch to batch consistency. OTAT advised the Blast that their approach is ‘reasonable’.
The current vacuum of information is causing undue FUD. There’s good reasons for delays (as frustrating as they may be). Thanks for all of your work over the years @ddwn
On top of your analysis, I don’t think you can understate the...
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