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Alias Born | 07/06/2020 |
Friday, November 26, 2021 11:53:01 AM
Type A Meetings are for:
Immediately necessary for an otherwise stalled drug development program to proceed. Type A meetings may include:
Dispute resolution meetings as described in the Code of Federal Regulations (CFR), and in the Guidance for Industry Formal Dispute Resolution: Appeals Above the Division Level
Meetings to discuss clinical holds in which development is stalled and a new path forward should be discussed
Special protocol assessment meetings that are requested by sponsors or applicants after receipt of FDA evaluation of protocols under the special protocol assessment procedures
Post-action meetings requested by the sponsor within 3 months after an FDA regulatory action other than an approval
Recent NRXP News
- NRx Pharmaceuticals (Nasdaq:NRXP) Reports First Quarter 2024 Financial Results and Provides Business Update • PR Newswire (US) • 05/14/2024 08:01:00 PM
- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) to Participate in the EF Hutton Annual Global Conference on May 15, 2024 • PR Newswire (US) • 05/08/2024 12:30:00 PM
- NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) to Report First Quarter 2024 Financial Results on May 14, 2024 • PR Newswire (US) • 05/07/2024 08:01:00 PM
- NRx Pharmaceuticals (Nasdaq:NRXP) Announces Final Clinical Trial Results: Superior Safety Combined with Similar Efficacy in the Trial of NRX-101 Compared to Lurasidone in Suicidal Bipolar Depression • PR Newswire (US) • 05/06/2024 12:30:00 PM
- NRx Pharmaceuticals (Nasdaq:NRXP) Announces Promising Findings in Phase 2b/3 Clinical Trial of NRX-101 vs. Lurasidone for Treatment of Suicidal Bipolar Depression • PR Newswire (US) • 04/30/2024 12:30:00 PM
- NRx Pharmaceuticals (NASDAQ:NRXP) Receives Notice from Nasdaq that the Company has Demonstrated Compliance with the Bid Price Requirement • PR Newswire (US) • 04/18/2024 12:32:00 PM
- NRx Pharmaceuticals, Inc. Announces Pricing of $2.0 Million Underwritten Public Offering of Common Stock • PR Newswire (US) • 04/18/2024 12:30:00 PM
- NRx Pharmaceuticals, Inc. Announces Proposed Underwritten Public Offering of Common Stock • PR Newswire (US) • 04/17/2024 08:45:00 PM
- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces New Data on NRX-101 Demonstrating No Damage to Intestinal and Vaginal Flora in Validated Rodent Models Compared to Standard Antibiotics: Potential Implications for Avoidance of C. Difficile infections • PR Newswire (US) • 04/17/2024 12:30:00 PM
- NRx Pharmaceuticals (NASDAQ:NRXP) Announces Development of New, Proprietary Formulation of HTX-100 (IV Ketamine) • PR Newswire (US) • 04/15/2024 12:30:00 PM
- NRx Pharmaceuticals (NASDAQ:NRXP) Announces Data-Lock of Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression • PR Newswire (US) • 04/08/2024 12:30:00 PM
- NRx Pharmaceuticals (Nasdaq:NRXP) Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update • PR Newswire (US) • 04/01/2024 12:28:00 PM
- NRx Pharmaceuticals (NASDAQ:NRXP) Reports Preliminary Fourth Quarter and Full Year 2023 Financial Results and Provides Year End Highlights • PR Newswire (US) • 03/28/2024 12:03:00 PM
- NRx Pharmaceuticals Announces Reverse Stock Split to Maintain Nasdaq Listing • PR Newswire (US) • 03/28/2024 12:00:00 PM
- NRx Pharmaceuticals (NASDAQ: NRXP) to Report Fourth Quarter and Full Year 2023 Financial Results on March 28, 2024 • PR Newswire (US) • 03/26/2024 08:03:00 PM
- NRx Pharmaceutical's (NASDAQ:NRXP) Chairman Dr. Jonathan Javitt to Present at the Ketamine 2024 Conference in Oxford, UK • PR Newswire (US) • 03/25/2024 12:30:00 PM
- NRx Pharmaceuticals to Report Fourth Quarter and Full Year 2023 Financial Results and Provide a Corporate Update on March 28, 2024 • PR Newswire (US) • 03/21/2024 08:02:00 PM
- NRx Pharmaceuticals Announces Results of the Vote Held During the Special Meeting of Shareholders • PR Newswire (US) • 03/21/2024 05:57:00 PM
- NRx Pharmaceuticals (NASDAQ:NRXP) Initiates Strategy to Combat Short Sales • PR Newswire (US) • 03/12/2024 11:49:00 AM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 03/11/2024 09:16:06 PM
- NRx Pharmaceuticals (NASDAQ:NRXP) Completes Memorandum of Understanding and Collaborations with Distribution Partners for HTX-100 (IV Ketamine) • PR Newswire (US) • 03/11/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 09:08:01 PM
- NRx Pharmaceuticals (NASDAQ: NRXP) Announces Last Patient, Last Visit in its Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression • PR Newswire (US) • 03/04/2024 01:30:00 PM
- NRx Pharmaceuticals Announces Definitive Purchase Agreement for Common, Unregistered Shares at $0.38 per Share • PR Newswire (US) • 03/01/2024 01:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/28/2024 10:09:27 PM
Branded Legacy, Inc. Unveils Collaboration with Celebrity Tattoo Artist Kat Tat for New Tattoo Aftercare Product • BLEG • May 22, 2024 8:30 AM
"Defo's Morning Briefing" Set to Debut for "GreenliteTV" • GRNL • May 21, 2024 2:28 PM
North Bay Resources Announces 50/50 JV at Fran Gold Project, British Columbia; Initiates NI 43-101 Resources Estimate and Bulk Sample • NBRI • May 21, 2024 9:07 AM
Greenlite Ventures Inks Deal to Acquire No Limit Technology • GRNL • May 17, 2024 3:00 PM
Music Licensing, Inc. (OTC: SONG) Subsidiary Pro Music Rights Secures Final Judgment of $114,081.30 USD, Demonstrating Strength of Licensing Agreements • SONGD • May 17, 2024 11:00 AM
VPR Brands (VPRB) Reports First Quarter 2024 Financial Results • VPRB • May 17, 2024 8:04 AM