Sunday, August 08, 2021 11:26:41 AM
---------
Updated preprint:
https://privpapers.ssrn.com/sol3/papers.cfm?abstract_id=3830051
--------------
Jonathan Javitt from Yh0
Since there seems to be some confusion about what the preprint says, I'm going to restate the science.
ALL PATIENTS IN THE STUDY ARE INCLUDED in all top-level analyses of the primary endpoint. If you see n=196 that refers to all patients treated. Analysis of endpoints within subgroups only follows reports of endpoints for all patients, according to scientific best practice.
That said, the original study protocol as approved by FDA specified that primary endpoints would be analyzed in a regression model that includes covariates that control for differences between the drug-treated and the placebo group at baseline. In this study, the randomization program implemented by the third party CRO assigned more severe patients to the drug group than to the placebo group (see table 3 baseline characteristics .
Remember, when you randomize patients, the computer is "flipping coins" and you should not expect that patients will always be matched in baseline characteristics. The regression analyses used were pre-agreed with FDA at the outset of the study and the manner in which covariates are used also follows published FDA guidance.
The study initially planned to use NIAID score as a measure of baseline severity and the statistical analysis plan was modified prior to unblinding to use type of ventilation as a measure of baseline severity instead because it was a more objective measure.
Readers are clearly free to interpret data as they choose. However, it’s important to understand the data in the first place. All patients, all hospitals, in the primary analysis means exactly that. Nobody was excluded.
This comment will also be posted to our website
~ Money Making Money ~
Recent NRXP News
- HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Announce Potential Acquisition and Financing Agreements for $30 Million in Currently-Operating Interventional Psychiatry Clinics • PR Newswire (US) • 08/26/2024 11:55:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/20/2024 08:38:59 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2024 09:27:16 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 08:39:03 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 08/14/2024 08:30:43 PM
- NRx Pharmaceuticals (NASDAQ:NRXP) Reports Second Quarter and Year to Date 2024 Financial Results and Provides Business Update • PR Newswire (US) • 08/14/2024 08:01:00 PM
- NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) to Report Second Quarter and Year to Date 2024 Financial Results on August 14, 2024 • PR Newswire (US) • 08/13/2024 08:01:00 PM
- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Up to $16 Million Senior Secured Debt Financing from Anson Funds • PR Newswire (US) • 08/13/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/12/2024 09:15:45 PM
- HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Announce Alignment with FDA on Pediatric Study Plan for NRX-100 (ketamine) • PR Newswire (US) • 07/29/2024 12:35:00 PM
- HOPE Therapeutics, Inc. and NRx Pharmaceuticals (Nasdaq:NRXP) Announce Arbitration Order Enabling HOPE Therapeutics Spinoff • PR Newswire (US) • 07/29/2024 12:30:00 PM
- NRx Pharmaceuticals (NASDAQ:NRXP) Publishes Shareholder Update Letter • PR Newswire (US) • 07/01/2024 12:07:00 PM
- NRx Pharmaceuticals (NASDAQ:NRXP) to Proceed with Two New Drug Applications in 2024; NRX-101 has Been Returned to the Company for Filing • PR Newswire (US) • 06/28/2024 12:07:00 PM
- NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) to Participate in the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference on June 27, 2024 • PR Newswire (US) • 06/20/2024 12:30:00 PM
- NRx Pharmaceuticals (NASDAQ:NRXP) Appoints Neuroscience, Information Technology and Medical Technology Veteran to its Board of Directors • PR Newswire (US) • 06/18/2024 12:30:00 PM
- NRx Pharmaceuticals (NASDAQ:NRXP) Publishes Shareholder Update Letter • PR Newswire (US) • 06/10/2024 12:30:00 PM
- NRx Pharmaceuticals (Nasdaq:NRXP) Presents Landmark Trial of NRX-101 in Suicidal Bipolar Depression At the American Society of Clinical Psychopharmacology Annual Meeting: NRX-101 is the First Oral Antidepressant Demonstrated to Reduce Suicidality in Bipola • PR Newswire (US) • 05/28/2024 12:30:00 PM
- 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
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM