@whytee, in the Q&A section of the conference call of 31August,...

@whytee, in the Q&A section of the conference call of 31August, Dr Krause commented that the CRL did not question the efficacy of the product as was demonstrated in GVHD001, as had been the case in the previous CRL. Refer minute 41 of webcast at: https://webcast.openbriefing.com/msb-fyr-2023/

In the AGM, SI reinforced that FDA have now provided this feedback twice: once in the CRL and then again in the Type A meeting. It was also in the AGM that SI said words to the effect that FDA indicated the trial would have been assessed as a potentially approvable adequate and well-controlled study but for an assay which was too variable. There is no available recording of that (I am going from memory) but perhaps other attendees at the AGM can verify this?

It is perhaps worth clarifying that SI did not indicate that the FDA said they 'would have approved' they study but for the assay.

The CRL and minutes themselves haven't been posted insofar as I'm aware. I wouldn't expect them to be.