@reginaldp - The FDA will highly likely be going through the process and tests indicated in the guidance I quoted, among other things, in my post in order to assess the resubmitted BLA. I simply can’t see, with the work having been done which was the subject of a lot of reasonable guesses here and which was reported elsewhere such as by Bell P, that the resubmission would have been done in any way other than as guided very explicitly by such guidances and draft guidances.
Cell Therapy News/Articles, page-17915
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