"is something from a IL2Ra assay has been presented that led to the FDA and the company changing their course."
I don't think so. IMO its Silviu the lawyer trying to weasel word his way through any gaps in the FDA responses to get them to reconsider the BLA without the risk of doing the additional trial that they requested. Hopefully some senior decision maker will realise what's going on and put a stop to ut for a third time, once and for all.
Cell Therapy News/Articles, page-17896
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