If the data is hocus pocus (and I agree that is what has been said) …….surely the FDA will not accept the submission and therefore he will be correct but the reverse is the same ie if the FDA accept the submission and grant marketing approval with a confirmatory trial the data prima facie must be acceptable and his theory is incorrect
We will not be able to solve this until the FDA rules in August
That is 147 days or 21 weeks …….crikey
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-343
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