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Double_Bagel

04/16/15 12:54 PM

#189990 RE: jq1234 #189989

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.

Congrats to all the holders, including Dew!
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GrthzGd

04/16/15 1:57 PM

#189992 RE: jq1234 #189989

Shea just said they'll be poring over these criteria to see what their competitors are likely to do.
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jq1234

04/16/15 2:12 PM

#189993 RE: jq1234 #189989

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.

https://twitter.com/jq1234t/status/588756589470818304
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DewDiligence

04/16/15 4:40 PM

#190002 RE: jq1234 #189989

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.