Elite Pharmaceuticals Inc (ELTP): Yes, on all accounts. Elite struggles to...

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Elite Pharmaceuticals Inc (ELTP)

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Re: Padin post# 324698

Saturday, 12/07/2019 7:55:42 AM

Saturday, December 07, 2019 7:55:42 AM

Yes, on all accounts. Elite struggles to understand ANDA and NDA requirements. I can’t think of any drug of theirs that was approved by the GDUFA or PDUFA date due to information missing for the FDA to review. And yes, Sungen 2 had an initial GDUFA of Mar 2019.

Many years ago Nasrat said the team is learning as they go. Not only does this hold for FDA submissions, but also the financials as the CFO has had to restate financial statements twice, but hey, it is ok. They are all learning as they go.

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Recent ELTP News

Form 8-K - Current report • Edgar (US Regulatory) • 06/05/2024 08:07:15 PM
Form 8-K - Current report • Edgar (US Regulatory) • 05/20/2024 08:30:31 PM
Form 8-K - Current report • Edgar (US Regulatory) • 02/14/2024 09:55:26 PM
Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/29/2023 07:21:28 PM
Form 8-K - Current report • Edgar (US Regulatory) • 12/26/2023 09:20:29 PM
Form 8-K - Current report • Edgar (US Regulatory) • 12/12/2023 09:20:20 PM
Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/28/2023 12:05:38 AM
Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/27/2023 11:58:46 PM
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Form 8-K - Current report • Edgar (US Regulatory) • 09/25/2023 08:15:15 PM
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Form 10-K/A - Annual report [Section 13 and 15(d), not S-K Item 405]: [Amend] • Edgar (US Regulatory) • 07/31/2023 08:20:27 PM
Form 8-K - Current report • Edgar (US Regulatory) • 07/17/2023 08:15:16 PM
Form 8-K - Current report • Edgar (US Regulatory) • 06/29/2023 09:15:09 PM
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