2023 Next Steps, page-152

Isn't that an assumption you are making in the absence of having seen the CRL?

Nope, it is based on fact. Fact that came directly from the mouth of Dr Krause, who has read the actual the CRL, and who said:

"one of the significant positive indicators from the CRL - is that the CRL did not question the efficacy of the product as demonstrated in GvHD001, (which was the case for the previous CRL )"

I am actually quite shocked that either you have not listened to the webcast, or you ignored what he said?



Maybe this is easier.... Isn't it an assumption you are making that the potency assay has not been validated, in the absence of seeing the CRL?
Can you reference any commentary from MSB following CRL2 that specifically says the potency assay is not valid, or remains to be validated?

Krause then goes on to say
" BUT The CRL did continue to raise questions about the potency assay, specifically the characterisation and standardisation of the product that went into GvHD001 and the ability to make future product that is similar to that which went into GvHD001. This leaves open the real possibility that by using exactly the same assays that were used to characterise the product that went into the GvHD001 trial, for new commercial product, that it would be possible to show that the new commercial product is similar enough to that which was effective in GvHD001. "

Nowhere was FDA questioning the efficacy
Nowhere was FDA stating the potency assays were inadequate