remestemcel-L has NOT been rejected by the F
DA. A CRL is in fact "approved if you meet condition X". Unlike Regenaron it has a flawless safety profile. Regenaron is on a phase 1/2/3 trial and needs to meet the endpoints for each phase. It looks good so far, but is for a different stage of the disease and largely unrelated to us. It is not a revolutionary new way to treat inflammatory disease and therfore is indeed not in same league as MSB's products.
remestemcel-L has NOT been rejected by the FDA. A CRL is in fact...
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