Yes it does, because MSB have also not said the potency assay is unproven. That is speculation on your part.
CBER said the approach to potency assay was reasonable, and that CQA also looked reasonable.
If the FDA thought the potency assay was unproven, then FDA would insist on another trial, and FDA would have stated in CRL#2 there is no correlation between potency and outcomes.
Thanks to the work done on the IL2RALPHA assay, we know there is a correlation between potency and survival. This is also the case with TNFR1 in previous trials.
You are speculating based on no evidence, again you have not read the CRL#2, and MSBs comments do not match an FDA comment that potency is unproven.
Yes it does, because MSB have also not said the potency assay is...
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