I don’t think it is on the grounds of efficacy or safety. Rather on manufacturing.
This could be a relatively quick fix, I mean there are two types of CRLs.
Type 1 (minor) is a 2 month review time by the FDA. And a Type 2 is a 6 month review time.
So if MSB get a CRL recommending some minor manufacturing changes, and they go and fix it in a couple of weeks... then they submit the reports / data to the FDA and they have 2 months to approve or issue another CRL.
if it’s deemed a major submission (type 2), then the FDA have 6 months to review it.
Ann: Trading Halt, page-559
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