This tentative approval of Tlando is another garbage delay...
I think Lipocine has a good chance of winning their patent dispute against Clarus in court.
However, I know litigation is delayed, due to Covid being used as an excuse.
I also know, that if Lipocine wins in court, that Clarus will appeal many times and the FDA will drag their feet on giving Tlando full approval, with the exclusivity rights being removed from Clarus and those rights being given over to their rightful owner, Tlando.
In my opinion, Clarus should have never received FDA approval.
Hopefully, the phase II NASH results will be excellent and will be announced in January.
It would be even better if the NASH results were so good, that a phase III is not required and the drug can be brought to market for the treatment of NASH much sooner.
Recent LPCN News
- Lipocine Announces LPCN 1154 Meets Bioequivalence with IV Brexanolone in Pivotal Study • PR Newswire (US) • 06/25/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/10/2024 01:00:30 PM
- Lipocine Presents 52 Week Results from LPCN 1148 Phase 2 Study in Late Breaking Session at EASL Congress 2024 • PR Newswire (US) • 06/10/2024 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 09:48:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 09:45:33 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 09:43:25 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 09:41:45 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 09:39:17 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/05/2024 08:32:30 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/03/2024 09:15:12 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 06/03/2024 09:09:23 PM
- Lipocine Announces Financial Results for the First Quarter Ended March 31, 2024 • PR Newswire (US) • 05/09/2024 12:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 10:06:19 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 10:03:08 AM
- Lipocine Announces Late Breaking Oral Presentation of Data from the Phase 2 Study of LPCN 1148 at EASL Congress 2024 • PR Newswire (US) • 05/08/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/08/2024 10:15:30 AM
- Lipocine Announces Completion of Dosing in Pivotal Study of Postpartum Depression Candidate, LPCN 1154 • PR Newswire (US) • 05/01/2024 12:00:00 PM
- Lipocine Announces Positive LPCN 2401 Clinical Results Showing Improved Body Composition in Participants with Obesity • PR Newswire (US) • 04/11/2024 11:00:00 AM
- Lipocine Announces Positive Week 52 Results from LPCN 1148 Phase 2 Study in Patients with Cirrhosis • PR Newswire (US) • 03/28/2024 12:00:00 PM
- Lipocine Announces First Cohort Dosed in Pivotal Study of LPCN 1154 • PR Newswire (US) • 03/25/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 10:31:06 PM
- Lipocine Announces Financial Results for the Full Year Ended December 31, 2023 • PR Newswire (US) • 03/07/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 11:08:06 AM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/07/2024 11:07:26 AM
- Lipocine to Present at 36th Annual Roth Conference • PR Newswire (US) • 03/06/2024 01:00:00 PM
Glidelogic Corp. Becomes TikTok Shop Partner, Opening a New Chapter in E-commerce Services • GDLG • Jul 5, 2024 7:09 AM
Freedom Holdings Corporate Update; Announces Management Has Signed Letter of Intent • FHLD • Jul 3, 2024 9:00 AM
EWRC's 21 Moves Gaming Studios Moves to SONY Pictures Studios and Green Lights Development of a Third Upcoming Game • EWRC • Jul 2, 2024 8:00 AM
BNCM and DELEX Healthcare Group Announce Strategic Merger to Drive Expansion and Growth • BNCM • Jul 2, 2024 7:19 AM
NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM
Mass Megawatts Announces $220,500 Debt Cancellation Agreement to Improve Financing and Sales of a New Product to be Announced on July 11 • MMMW • Jun 28, 2024 7:30 AM