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Re: numbersarefun post# 24464

Sunday, 02/26/2017 8:04:29 PM

Sunday, February 26, 2017 8:04:29 PM

Post# of 38634
Numbers - I hope you understood that I was refuting J_Cali's assertion that Pfizer dropped Remoxy because they had ALO-02... they dropped Remoxy because they failed twice and apparently they believed it would have failed a third time... which it did.

But your timeline introduces an interesting point.

Feb 13, 2015 Pfizer's Troxyca NDA Accepted for Review. So probably filed NDA in December 2014.
Aug 19, 2016 FDA Approves Troxyca ER.

So if the NDA was filed in December and accepted in February, then I imagine they were given the standard review time frame of 10 months from the December application... putting the PDUFA date at October... but it was approved in August which was 2 months earlier... which may well mean we may get approval 2 months earlier, or as early as end of July if they follow suit with IPCI.

Numbers... it's important... Do you have the specific PDUFA date Pfizer were given???

Perhaps the FDA gives out a standard timeframe for the PDUFA but expedites the approval anyway. 8 months would be halfway between Standard (10 months) and Expedited (6 months).

That would be nice.