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jbog

07/26/13 3:07 PM

#10741 RE: DewDiligence #10737

Regarding MYL’s ANDA, I have no insights other than to note that MYL acquired the product from India’s Natco, where approval standards for FoB’s are relatively low.



The problem is that the FDA rarely rejects a generic but rather just lets them collect dust in a corner. It'll be a cloud over generic copax no matter what happens.
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dumaflotchie

07/26/13 3:49 PM

#10744 RE: DewDiligence #10737

Please allow me a very simplistic question with the following background that I may be misunderstanding:

MNTA originally touted a huge technology prowess that would enable it to produce exact generic copies of complex medicines at reduced development time and cost.

Yet in the case of lovenox, a competing generic appeared in rapid succession and now with capoxone, another generic wannabe is in the wings even before any generic is approved by FDA.

I also understood that the capoxone contractual agreement again calls for dramatic reduced income to MNTA in the case of a second generic approval (similar to the lovenox situation). Dew has corrected that and confirmed tnat MNTA gets no reduction in % with another generic (other than market share issues)

So are investors better off to sell with capoxone approval (or even before) because once(if) Myl gets approval.......yet another thrashing of MNTA income and its stock price.

There doesn't seem to be another MNTA generic drug on the starting blocks awaiting FDA approval after capoxone.

Thanks in advance for your responses.
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jbog

08/04/13 6:37 PM

#10810 RE: DewDiligence #10737

I think there’s a 72% probability that the FDA approves MNTA’s Copaxone ANDA before Teva’s patents expire in May 2014.



Considering that you thought there was a greater than 90% probability that the CERT would be granted and a 80% chance USSC takes the case doesn't bode well here.