Because all the FDA has said is that they can refile the application.
They have done this twice in the past. It sounds like the FDA may now be ok with the potency, but have they changed their minds on needing further evidence?
More specifics would be nice.
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- Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-26
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