So, the question is are they going to launch before September?
Too bad I got completely out of MNTA on the initial spike to $14 using covered calls. Well, I put that money in CLVS, ISIS, BLUE etc. So, I don't feel too bad on missing out.
In addition to the characterizations and assays performed by generic sponsors, FDA’s internal laboratory developed and performed its own testing97 of multiple batches of Copaxone, the proposed generic glatiramer acetate injection, glatiramer acetate-like products marketed outside of the United States,98 and negative controls, in each case using high-resolution analytical techniques.
MNTA—In contrast to the FDA’s response to SNY’s Lovenox CP, this time the FDA is not providing a detailed roadmap for other would-be generics to simply copy what MNTA has done. The change in policy is not an accident, according to Craig Wheeler on today’s CC.