If the FDA did not have one (or more) significant concerns, they could have just gone ahead and approved Twirla, even with a black box warning if necessary. They already had cover to take this action from their ADCOM meeting.
Of course this doesn't mean that Twirla won't be approved (with or without a black box warning) once the FDA has had time to review the new info Agile is supplying.
In the meantime, holders of AGRX have some hard decisions to make. Hold strong? Sell and re-enter in a couple months? Or just sell and move on to another play?
No easy decisions here imho. Even the shorts have somewhat similar decisions to make.
Disclaimer: I am currently neither long nor short AGRX shares although I am closely following this stock for a possible entry in the future.
Recent AGRX News
- Agile Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update • GlobeNewswire Inc. • 05/15/2024 08:10:00 PM
- Agile Therapeutics Reports Fourth Quarter & Full Year 2023 Financial Results and Provides Corporate Update • GlobeNewswire Inc. • 03/28/2024 12:05:00 PM
- Agile Therapeutics Announces Delisting from Nasdaq • GlobeNewswire Inc. • 03/25/2024 08:30:00 PM
- Correction - Agile Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results and Provide Business Update on Thursday, March 28, 2024 • GlobeNewswire Inc. • 03/21/2024 10:35:00 AM
- Agile Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results and Provide Business Update on Friday, March 22, 2024 • GlobeNewswire Inc. • 03/20/2024 12:15:00 PM
- Agile Therapeutics Completes Pay-off of Debt and Remains Focused on Business Plan Execution • GlobeNewswire Inc. • 03/13/2024 11:31:00 AM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 02/23/2024 09:57:00 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 02/23/2024 09:55:25 PM
- Agile Therapeutics Announces Exercise of Warrants for $4.8 Million Gross Proceeds • GlobeNewswire Inc. • 02/22/2024 02:01:22 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/15/2024 09:45:30 PM
- Agile Therapeutics Announces Extension Granted by Nasdaq Hearings Panel to Regain Compliance with the Stockholders’ Equity Continued Listing Requirement & Provides Performance Update • GlobeNewswire Inc. • 02/15/2024 09:30:00 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 01:02:00 AM
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 02/07/2024 09:51:10 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/06/2024 03:14:35 PM
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 02/05/2024 02:21:25 PM
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 02/02/2024 09:27:13 PM
- The Biden-Harris Administration Announces New Guidance to Enable Expanded Access to All FDA-Approved Contraceptives Without Cost • GlobeNewswire Inc. • 01/23/2024 02:29:00 PM
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 12/20/2023 01:00:42 PM
- Agile Therapeutics Provides Update on Actions Being Taken to Strengthen the Affordable Care Act’s No-Cost Contraceptive Coverage Requirement • GlobeNewswire Inc. • 12/12/2023 01:01:00 PM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 12/11/2023 10:30:40 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/06/2023 01:00:16 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/04/2023 01:00:44 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/09/2023 09:30:51 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/09/2023 01:15:21 PM
- Agile Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update • GlobeNewswire Inc. • 11/09/2023 01:05:00 PM
Bantec's Howco Short Term Department of Defense Contract Wins Will Exceed $1,100,000 for the current Quarter • BANT • Jun 25, 2024 10:00 AM
ECGI Holdings Targets $9.7 Billion Equestrian Apparel Market with Allon Brand Launch • ECGI • Jun 25, 2024 8:36 AM
Avant Technologies Addresses Progress on AI Supercomputer-Driven Data Centers • AVAI • Jun 25, 2024 8:00 AM
Green Leaf Innovations, Inc. Expands International Presence with New Partnership in Dubai • GRLF • Jun 24, 2024 8:30 AM
Bemax Inc. Positions to Capitalize on Industry Growth with New Improved Quality of Mother's Touch® Disposable Diapers • BMXC • Jun 24, 2024 8:00 AM
Last Shot Hydration Drink Announced as Official Sponsor of Red River Athletic Conference • EQLB • Jun 20, 2024 2:38 PM