Replies to post #382813 on Elite Pharmaceuticals Inc (ELTP)

[bubba412]

Do you mean Feb 23 or 24 ?

[IB_]

If the OxyContin ANDA is approved (which I'm sure it will not be) who will NasRat sell the ANDA to ????????????????????? Mikah ????????????????????

IB_

[mrwrn2010]

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?

[The ELTP King]

I'm already on RECORD stating we could get the approval in the 1st calendar quarter of 2024.

Here ya go:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172267344

The midpoint period between your suggested dates the insufflation study was possibly submitted to get a PDUFA date would be April 16, 2023. If PDUFA date was established at that time, it is possible that the company will receive approval of its OxyContin ANDA as early as February 16, 2023(2024) if the usual 10 month waiting period applies.