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rwwine

02/11/17 2:58 PM

#16622 RE: DewDiligence #16620

Thanks Dew for the clarity on the subject. It is my contention that each application would/wouldn't be approved by the FDA their own merits and have nothing to do with each other and/OR any being "held up" until all applications have been completely reviewed. In this case, MNTA clearly has the advantage since their 20 mg dose product has been on the market. In your opinion, am I out of touch with reality?
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jbog

02/11/17 3:23 PM

#16623 RE: DewDiligence #16620

So, at worst, MNTA filed on the same day as other 40mg-Copaxone ANDA filers.



Acually I think the first recorded filer was Dr Reddys on Aug 8th 2014 And that is why the 30 month period was Feb 8th 2017. It was Either Reddys filing or acceptance that generated the first paragraph IV notice.

I believe Momenta and Mylan both had their filings accepted 3 weeks later on the 28th of August.