hmmm, not sure about that
when I look up the summary of the CRL, sources all say FDA request “at least one” additional trial in “adult or paediatric gvhd”. I don’t think the covid trial covers that
i take your point re MOA and quality though
it’s just hard for me to see how the FDA would request at least one further study and then approve a drug without all the previously requested requirements being met!?
anyways thanks for the explanation
Ann: S&P DJI Announces March 2022 Quarterly Rebalance, page-55
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