The market including MSB shareholders went all the way from ODAC...

The market including MSB shareholders went all the way from ODAC (Aug 2020) and the first CRL (October) to May 2022 before it was acknowledged by Eric Rose that there was a problem with the potency assay.

To my knowledge the specific nature of that problem has not been detailed - its been reported second hand that there were problems with a reagent of something. If it was to do with TNFR1 - that is patented now in the US - no need to keep it under wraps.

Personally I don't think FBS is that much of a problem (better not to have it) but I don't think assuming MSB will inform the market of what is in a CRL is wise.

Its that long lead time of non disclosure - where the market was permitted, encouraged even, (John Hester of Bell Potter spoke of goal posts moving by the FDA - he was apparently ignorant of the potency assay problem) to think that there were no problems, not real ones, just problems with the FDA's approach or finickiness or something,that I think causes doubts still.

Had the FDA granted a BLA in October 2020 instead of the CRL - do you think Silviu would have said - no wait - we still have a potency assay problem? When the product is apparently still harmless when it isn't potent?