Elite Pharmaceuticals Inc (ELTP): "The FDA had all of this information abo...

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Re: IB_ post# 219452

Tuesday, 08/02/2016 10:40:34 AM

Tuesday, August 02, 2016 10:40:34 AM

"The FDA had all of this information about SequestOx and they still sent Elite" a $2.5 waiver of application fee and a priority review!!!

"Safety issue" (T-max) for SequestOx is exactly the same as for all other IR opioids! Simple labeling instructions take care of that issue just like on all other IR opioids "Take 1 hour before a meal or 2 hours after a meal". Can add "Do not exceed 2 caps within 4 hours" (or whatever the correct amount is, i am not certain).

In addition, while waiting for the FDA to approve SequestOx (which it will), there is CHINA! It could be approved in China regardless of status in USA. HUGE market.

Our guy Eugene has won his case many many times before and he will do so this time as well! ELTP WILL PREVAIL!

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