The PR is clear, they’re still talking. The FDA could ask for more data, or thy could expedite the approval process. The PR says both options are still on the table.
This article talks about various pathways available and how some of them don’t even consider long and expensive Phase 3 trials:
https://www.biosimilardevelopment.com/doc/how-the-regulatory-pathway-shapes-biosimilar-business-decisions-0001
Recent OCGN News
- Ocugen to Participate in a Fireside Chat at Chardan’s 8th Annual Genetic Medicines Conference • GlobeNewswire Inc. • 09/24/2024 11:30:00 AM
- Ocugen Chairman, CEO & Co-founder, Dr. Shankar Musunuri, to Speak During U.S.-India Initiative on Critical and Emerging Technology Workshop • GlobeNewswire Inc. • 09/09/2024 10:30:12 AM
- Ocugen CSO to Participate in 5th Annual Gene Therapy for Ophthalmic Disorders Summit • GlobeNewswire Inc. • 09/05/2024 11:00:07 AM
- Ocugen to Participate in a Fireside Chat at the H.C. Wainwright 26th Annual Global Investment Conference • GlobeNewswire Inc. • 09/03/2024 11:30:42 AM
- Ocugen Announces Completion of Dosing in Subjects with Stargardt Disease in High Dose Cohort of Phase 1/2 GARDian Clinical Trial of OCU410ST—A Modifier Gene Therapy • GlobeNewswire Inc. • 08/28/2024 10:30:32 AM
- Ocugen, Inc. Announces Health Canada Approval to Initiate Phase 3 Clinical Trial for OCU400 – Modifier Gene Therapy for Broad Retinitis Pigmentosa Indication • GlobeNewswire Inc. • 08/26/2024 11:02:41 AM
- Ocugen, Inc. Investor Alert (NASDAQ: OCGN): Schubert Jonckheer & Kolbe LLP Investigating Potential Claims Against the Company's Officers and Directors Following Earnings Restatement and Possible Insider Trading • PR Newswire (US) • 08/20/2024 01:00:00 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 08/16/2024 08:16:42 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/13/2024 12:00:42 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/08/2024 05:03:56 PM
- Ocugen Provides Business Update with Second Quarter 2024 Financial Results • GlobeNewswire Inc. • 08/08/2024 10:45:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/08/2024 10:06:10 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/05/2024 11:18:41 AM
- Ocugen, Inc. Announces FDA Approval of Expanded Access Program for Patients with Retinitis Pigmentosa • GlobeNewswire Inc. • 08/05/2024 10:30:33 AM
- Ocugen, Inc. Announces Closing of $35 Million Public Offering of Common Stock • GlobeNewswire Inc. • 08/02/2024 07:22:33 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 08/01/2024 01:18:08 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/01/2024 01:16:00 PM
- Ocugen, Inc. Announces Pricing of $35 Million Public Offering of Common Stock • GlobeNewswire Inc. • 08/01/2024 01:15:46 AM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/31/2024 08:16:21 PM
- Ocugen, Inc. Announces Proposed Public Offering of Common Stock • GlobeNewswire Inc. • 07/31/2024 08:15:04 PM
- Ocugen to Host Conference Call on Thursday, August 8 at 8:30 A.M. ET to Discuss Business Updates and Second Quarter 2024 Financial Results • GlobeNewswire Inc. • 07/29/2024 11:02:15 AM
- Ocugen, Inc. Announces Completion of Dosing in Subjects with Geographic Atrophy Secondary to dAMD in High-Dose Cohort of Phase 1/2 ArMaDa Clinical Trial of OCU410—A Novel Modifier Gene Therapy • GlobeNewswire Inc. • 07/25/2024 10:30:20 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/08/2024 08:31:01 PM
- Ocugen Announces Data and Safety Monitoring Board Approves Enrollment in High Dose Cohort 3 in GARDian Study for Stargardt Disease • GlobeNewswire Inc. • 06/21/2024 11:00:00 AM
- Ocugen, Inc. Announces First Patient Dosed in Phase 3 liMeliGhT Clinical Trial for OCU400—First Gene Therapy in Phase 3 with a Broad Retinitis Pigmentosa Indication • GlobeNewswire Inc. • 06/20/2024 10:30:31 AM
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