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Re: Williams4076 post# 56836

Tuesday, 08/18/2015 3:19:10 PM

Tuesday, August 18, 2015 3:19:10 PM

Post# of 447325
If the FDA approves before July 2017 - they can do Nunc Pro Tunc with the start date of July 2012. With 30 month stay it takes us out to December 2019/Jan 2020 if I understand correctly.

However, lets say they once again decide to put AMRN in the corner chair for being bad - and decide not to adjudicate the NCE until long after the July 2017 timeframe. Can they still grant the 5 year exclusivity Nunc Pro Tunc and drop us into an already expired protection peiord - or the end - of the 30 month stay period floundering without knowing what the heck status we have?

Or is there some regulation which gives us at least a period of continuation with regards to protection?
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