Tuesday, February 06, 2024 6:37:48 AM
Good morning Meschcan, I know as much about elite's filings and project sales numbers as all of you. I can only pass on the information given to me and yes I feel Elite can capture 8% of the ER market based on how they have done in the IR market. With regards to the Vyvanse filing I think launching in 2024 is way to aggressive. As I have mentioned before, an ANDA gets assigned a GUDUFA date when the FDA accepts the filing, on average this is 9 months from the date of acceptance. My experience is that 90% of these filings get a CRL, now a CRL can be a minor or major. A minor typically you have 2-3 months to respond and you keep you line in Que, once you respond you get a new GUDUFA date of about 6-9 months. A major you go back to the back of the line and usually have up to a year to respond and then your GUDUFA date is assigned at response and based on how many other ANDAs are ahead of yours. Now the FDA also has this little game, which they played on our ANDA filing and they like to give you an additional information request letter close to the GUDUFA date and then they extend the date out 3 months. Basically, what I am saying is trying to time the FDA approval is very hard. The key is that Elite now has 4 ANDAs filed and that is big as they are all moving towards approval and we have cash coming in to continue to grow our pipeline. A 2024 launch for the Vyvanse is I feel is possible but not a reality, I would say Q1/Q2 2025 calendar year. The generic Oxycontin is really what has me excited as if they beat the patent, they should get 6 months exclusivity. This is the product I am watching the most as I feel this is one that will put Elite on the map and on every traders radar. As Newman from Seinfeld always said "have a great no feel Tuesday" Russ
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
