Mr. Michael Frank reports
REVIVE THERAPEUTICS ANNOUNCES UPDATE FOR TYPE C MEETING TO DISCUSS AMENDED PROTOCOL AGREEMENT OF PHASE 3 CLINICAL STUDY FOR BUCILLAMINE IN THE TREATMENT OF COVID-19
Revive Therapeutics Ltd. will submit the Type C meeting request package to the United States Food and Drug Administration (FDA) by mid-December, 2022, which will outline the overall development plan and predose selection data supporting the latest revised end-points for the company's phase 3 clinical trial (NCT04504734) to evaluate the safety and efficacy of bucillamine, an oral drug with anti-inflammatory and anti-viral properties, in patients with mild to moderate COVID-19. Following the submission of the Type C meeting request package, the company expects to hear from the FDA on a firm date for the meeting.
The company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 coronavirus) at this time.
About Revive Therapeutics Ltd.
Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as orphan drug, fast-track, breakthrough therapy and rare pediatric disease designations. Currently, the company is exploring the use of bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of psilocybin-based therapeutics in various diseases and disorders. Revive's cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation.
We seek Safe Harbor.
© 2023 Canjex Publishing Ltd. All rights reserved.