Tuesday, February 24, 2015 1:58:49 PM
Jan 15 to Mar 15, 2015: Enroll 150 patients and finalize multi-center selection sites.
Mar 15, 2015: Receive FDA comments and finalize protocol for 150 patients with moderate to severe pain following surgery efficacy P3 clinical trial.
Apr 1, 2015: Begin double-blind 8 week dosing. 75 patients on ELI200; 75 patients on Placebo.
Jun 1, 2015: Complete dosing and begin summarizing statistics report for submittal to FDA NDA ELI200 approval.
Jul 1, 2015: Submit statistics report to FDA for NDA ELI200 approval. FDA says that $ELTP will receive FDA comments in 6 months following receipt of the ELI200 P3 statistical results.
Jul 1-Dec 30, 2015: Complete installation and testing ELI200 manufacturing equipment as well as SOPs test runs. All of ELI200 equipment, new and shared, will be totally tested with integration of $ELTP’s current ANDAs scheduling. Critical time-schedules for ELI200 and $ELTP ANDAs will be fully enacted and finalized.
Jan1 - Jan 15, 2016: Receive FDA review for expected NDA ELI200 approval.
Feb 1, 2016: Finalize NDA ELI200 1st Commercial batch in readiness for marketing sales to pharmaceutical warehouses.
Mar 1 - Mar 30, 2016: Complete NDA ELI200 shipment to pharmaceutical warehouses.
Apr 1 - Jun 30, 2016: Receive NDA ELI200 NDA revenues to be reported in $ELTP FY1Q2017 10-Q.
Recent ELTP News
- 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
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- 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
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/27/2023 11:50:54 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 09/25/2023 08:15:15 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/07/2023 08:05:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2023 09:30:05 PM
- 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
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 06/29/2023 08:43:45 PM
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