This Philanthropist( Professor) has no chance.....
Big Rock SEC Review - Jan 27 2021
There is quite a lot of information in the SEC filing but I will point out some very important things mentioned.
Source: https://fintel.io/doc/sec-big-rock-partners-acquisition-corp-s4-2021-january-27-18654-7
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Our first VIP-derived product - ZYESAMI (RLF-100), the NeuroRx COVID-19 Drug - was awarded Fast Track designation by the FDA in June 2020 and admitted to the Coronavirus Treatment Acceleration Program. NeuroRx is currently conducting Phase 2b/3 clinical trials, with read out data expected by January 28, 2021. Additional trials are being conducted via the NIH-sponsored ACTIV3 program and the I-SPY program.
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NeuroRx has filed for Emergency Use Authorization (“EUA”) to market ZYESAMI (RLF-100) in the United States in the fourth quarter of 2020. Should the clinical trial currently underway demonstrate clinical and statistical significance, NeuroRx hopes to receive EUA for ZYESAMI (RLF-100) in the first quarter of 2021, which EUA will provide NeuroRx with a year in which to complete the Chemical Manufacturing Controls (“CMC”), plant inspections, and advisory board requirements associated with traditional drug approvals.
ZYESAMI inclusion in NIH TESICO/ACTIV3b Clinical Trial for Critical COVID-19 and Respiratory Failure
ZYESAMI (RLF-100) has been selected by the steering committee of the Therapeutics for Severely Ill Inpatients with COVID-19 (“TESICO”) protocol funded by Operation Warp Speed through the National Heart, Lung, and Blood Institute (“NHLBI”) and the National Institute for Allergy and Infectious Disease (“NIAID”) of the National Institutes of Health (“NIH”). The protocol is part of the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (“ACTIV”) public private consortium. This clinical trial anticipates enrolling 600 patients in study sites located in US, EU, and UK in a factorial design that will compare ZYESAMI to Remdesivir for the treatment of Critical COVID-19 with respiratory failure. The TESICO trial is expected to commence in the first quarter of 2021.
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Plan for Achieving Project Goals and Objectives
Agreed Path to FDA New Drug Approval
In order to file for New Drug Approval, NeuroRx must prove safety and efficacy in adequately controlled studies. FDA has already agreed that a single, adequately controlled trial of sufficient statistical significance would be adequate for acceptance of a New Drug Application (“NDA”) by FDA. In May 2020, NeuroRx proceeded at risk to launch RLF-100_001 trial under IND 149.152. This trial is nearing completion and will yield top line data in the first quarter of 2021. Should this trial demonstrate multidimensional efficacy, it will be sufficient for NDA
NeuroRx has conducted Pre IND meetings with FDA on the intravenous use versions of aviptadil and has an open IND with FDA for treatment of COVID-19. IND 149,152.
NeuroRx filed IND 149,152 on March 26, 2020 and received a Study May Proceed letter on March 28. Fast Track designation was granted on 6/19/2020. The study seeks to demonstrate a difference between aviptadil and placebo on a composite endpoint of recovery from respiratory failure by day 10 and continued survival through day 28 in patients with Critical COVID-19. Two type A meetings were subsequently conducted to agree upon adequacy of non-clinical studies for NDA submission, study endpoints and statistical analysis plan. This is an endpoint change that was recommended by the study’s DMC following review of rapid clinical recovery reported in the first 21 patients. Because of this endpoint change, the total sample size was expanded from 144 to 165 patients. The FDA has agreed that a single, well-controlled trial with statistically significant results will be acceptable for drug approval. Signed, original copies of all non-clinical studies required for drug approval have been uploaded to IND 149,152 in eCTD format and reviewed by the FDA as part of the ongoing regulatory process. The FDA has explicitly stated we agree that the submitted toxicology studies are adequate to support the submission of a New Drug Application for use of intravenous aviptadil in critical COVID-19.
Path to Emergency Use Authorization
The FDA granted Expanded Access Protocol approval for the use of aviptadil in highly comorbid patients with respiratory failure on August 20, 2020. NeuroRx has filed for Emergency Use Authorization in patients with Critical COVID-19 related respiratory failure and severe comorbidities based on the 45-patient administratively assigned trial conducted at Houston Methodist Hospital. Final results from the RLF-100_001 study will be submitted to the FDA upon completion for consideration in the issuance of the EUA. FDA has advised NeuroRx that it will consider EUA upon review of randomized controlled data with 28 days of followup.
There's a lot more information detailed you can review on your own.
Source: https://fintel.io/doc/sec-big-rock-partners-acquisition-corp-s4-
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