Thanks so much for this well researched and unbiased post. The information contained is incredibly important in understanding the announcement.
From statements made by SI in regards to plans for the submission of the BLA I believe we are at least T-5 days from feed back.
Or have we already received feed back?
I don't think it likely but let's just presume that the FDA had responded on time.
A rejection of the data supporting the potency assay would in my opinion be a very market sensitive information and would require SI to announce this to the market. So that leaves something less significant such as section 4. Basically the parameters of the assay.
This could be the subject of ongoing discussion and delay.
Ann: Submits New Information to FDA IND File for SR-aGVHD, page-270
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