Elite Pharmaceuticals Inc (ELTP): What I’d like clarity on (did Nasrat cla...

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Re: imanjen13 post# 382813

Tuesday, 07/18/2023 2:15:13 PM

Tuesday, July 18, 2023 2:15:13 PM

What I’d like clarity on (did Nasrat clarify this?) is what are the timelines when you’ve had an existing ANDA filing already on the books (OxyContin generic) and it’s been in limbo pending supplementary info like the insufflation study/results? Once those are submitted, is it that 1-2 month window for another PDUFA date? So, hypothetically if results sent in 8/1/23, possible acceptance on 10/1/23, PDUFA date 8/1/24?

In other words, are we receiving zero benefit to the approval timeline from the Oxy ANDA itself having already been on file at the FDA for years now?

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