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