CMC is a sort of universal "gotcha" for drug/biotech companies.
MNTA's 40mg Copaxone is a case in point. SNY/REGN's Sarilumab is another (#msg-126139243, #msg-126123492). Genzyme (now SNY) had a CMC issue a few years ago that shut down one of the company's two main plants for an extended period and ended up costing hundreds of millions, if not billions, of dollars.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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