Bazsa wrote:
"Now we know that OTAC have agreed to our new potency assay . "
Baz, this statement of yours is wrong in my opinion. Not just in the trivial typo sense of OTAC being OTAT, (Office of Tissue and Advance Therapy) but in the more important sense of thinking that something that might happen in the future and that you hope will happen has already happened.
I believe that you believe, I don't believe you are trying to fool anyone, but I think you've gone beyond anything the company itself has claimed in its announcements to date. It seems like a lot of others are going along with you.
Can you provide any MSB announcement to substantiate it?
I think you've gone further than MSB did in its end of December 2021 announcement for instance.
MSB did not say in that announcement that the FDA (or OTAT within the FDA) had agreed to its new potency assay. MSB would be a lot further advanced if they already had that assurance - I don't think the FDA could even in principle give that assurance unless they'd already received and reviewed the resubmitted BLA with data to support it.
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