Monday, July 10, 2017 8:55:35 AM
Thanks for the info...I have been trying to grind through the Avridi FDA info and maybe I misread it. I thought they were at 4.3hr and SequestOx at 4.5hr for the Fed (high fat) meal. However I didn't clarify if this was standard fed conditions or with high fat. Where does your 167% number come from? Maybe Cmax was different was just focused on Tmax comparison.
Has anyone put a chart together with the data (as best we can find it) for Tmax in ALL conditions side-by-side. I agree that namtae is right...most likely its not even a rejection (status quo) based on the data I have seen. However its very possible I am missing something and thus my question about ALL results.
Their only hope short term, I suspect is that the new administration is feeling the pressure to do something about the opiod crisis and that the standard Fed is substantially better than Avridi...otherwise Avridi would (or should) see an approval before SequestOx. At a 23-1 rejection that is too much crow for the FDA to eat...
Has anyone put a chart together with the data (as best we can find it) for Tmax in ALL conditions side-by-side. I agree that namtae is right...most likely its not even a rejection (status quo) based on the data I have seen. However its very possible I am missing something and thus my question about ALL results.
Their only hope short term, I suspect is that the new administration is feeling the pressure to do something about the opiod crisis and that the standard Fed is substantially better than Avridi...otherwise Avridi would (or should) see an approval before SequestOx. At a 23-1 rejection that is too much crow for the FDA to eat...
Recent ELTP News
- Form 8-K - Current report • Edgar (US Regulatory) • 04/02/2026 12:05:23 PM
- Elite Pharmaceuticals Announces Commercial Launch of Methadone Hydrochloride Tablets • Newsfile • 04/02/2026 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/17/2026 10:10:32 PM
- Elite Pharmaceuticals, Inc. Reports Financial Results for the Third Quarter of Fiscal Year 2026 (three months ended December 31, 2025) and Provides Conference Call Information • Newsfile • 02/17/2026 09:19:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/17/2026 09:06:15 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/11/2026 09:35:26 PM
- Elite Pharmaceuticals, Inc. to Host Conference Call to Provide Corporate Update and Discuss Third Quarter 2026 Financial Results on February 18, 2026 • Newsfile • 02/11/2026 09:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/13/2026 09:35:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/14/2025 10:10:23 PM
- Elite Pharmaceuticals, Inc. Reports Financial Results for the Second Quarter of Fiscal Year 2026 Ended September 30, 2025 and Provides Conference Call Information • Newsfile • 11/14/2025 09:19:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/14/2025 09:11:38 PM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 11/12/2025 10:19:32 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/12/2025 12:15:37 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/10/2025 12:15:46 PM
- Elite Pharmaceuticals, Inc. to Host Conference Call to Provide Corporate Update and Discuss Second Quarter 2026 Financial Results on November 17, 2025 • Newsfile • 11/10/2025 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/26/2025 09:17:39 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 08/22/2025 01:39:01 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2025 08:37:09 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/08/2025 08:35:45 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/25/2025 10:05:07 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/10/2025 08:17:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/08/2025 08:15:11 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 07/08/2025 02:58:10 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/30/2025 08:27:51 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 06/30/2025 08:05:59 PM
