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Re: numbersarefun post# 24671

Friday, 03/03/2017 3:26:03 AM

Friday, March 03, 2017 3:26:03 AM

Post# of 38634
Samsa, Angelo, numbers,

one of the amendments of the Glucophage CRL is dated October 13, 2016.

The Agreement with MNK is end 28 of sept 2016.

This should tell us that the 3 ANDAs included in the Agreement were likely to be some on which the company didn't have any pending issue with the FDA. (one was indeed tentatively approved: Seroquel)

I guess it is something MKN would like to see/know before signing, right ?

This doesn't exclude that possible requirements from the FDA could have come after the Agreement signature, but I would say that the reason IPCI is reiterating the fact that they are confident about new approvals to come can be linked to the other 2 drugs included in the MKN Agreement not having pending issues with FDA.