Replies to post #116132 on Biotech Values

[DewDiligence]

Unlike Teva (who has sought to hide the origins of its Lovenox knockoff), MYL has been candid in acknowledging that its version of Copaxone is the same drug Natco sells as a Copaxone knockoff in India.

I don’t think MYL has a serious chance of getting FDA approval, whether or not they opt to run a clinical trial.

[jb_118]

re: mnta mylan and mCopx trials

I got the feeling from the Cohen call that they're MNTA trials, and they're bio-equivelence trials, not efficacy/safety. Whether Mylan does some too I don't think will carry any weight, since i'm pretty sure these are MNTA's and CW reiterated emphatically they're still on the j pathway and he hasn't seen anything to make him think otherwise.

[jq1234]

if it does turn out that mylan starts trials

By trial, if you mean safety and efficacy trial required by FDA, it means FDA deemed Mylan's application CANNOT be processed via 505j ANDA. I believe Mylan will disclose it - MNTA will too. This is material information since both are in court challenging Teva Copaxone patent. Without disclosure, it would mislead investors that the application is still via 505j. On the other hand, if you mean bioequivalence trial, there isn't any consequence.