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clock Created with Sketch. 08/10/20
11:29
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Originally posted by danzae:
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There seems to be a growing concensus on here that the FDA never planned to give full approval. And that the CRL is just the FDA pushing MSB to apply for the Accelerated Pathway, therefore covering themselves with a further trial and sending a statement to all companies applying for medical treatments - no shortcuts. ( if I can summarize simplistically)Fast Track designation - discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval correspondence from FDA about such things as the design of the proposed clinical trials
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I do agree that in retrospect there appears to be a hint of arrogance in MSC going for what somebody previously described as the "home run" full approval
(20min delay)