Elite Pharmaceuticals Inc (ELTP): Which doesnt mean the normal FDA period...

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Elite Pharmaceuticals Inc (ELTP)

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Re: namtae post# 196777

Tuesday, 04/26/2016 7:43:30 PM

Tuesday, April 26, 2016 7:43:30 PM

Which doesnt mean the normal FDA period for priority review is 6 months

Normally priority review is longer than 6 months. When telling a colleague about acceptance of the NDA back in March this colleague told me "plenty of time probably get approval in late September or October".
WRONG!

Make no mistake about it... N2K is right. This is at least 2 months sooner than the noraml review for such a drug NDA.
July 14th is about 2 months sooner than September or October.

Does it bother some on this board that Elites priority review is HOT? For giving such a short amended version of this review with all criterea met it is my opinion that the FDA feels SequestOx
is HOT.

Anyone in QC pharma knows what "hot" means. Stat... hot... asap.

July 14th, 2016 ... coming soon.

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