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Revive Therapeutics Ltd. C.RVV

Alternate Symbol(s):  RVVTF

Revive Therapeutics Ltd. is a Canada-based life sciences company. The Company is focused on the research and development of therapeutics for rare disorders and infectious diseases. The Company is exploring the use of Bucillamine for the treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. Through its subsidiary, Psilocin Pharma Corp., the Company is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. The Company’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the Company was granted Food and Drug Administration (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.


CSE:RVV - Post by User

Post by Trippedstockson Feb 15, 2021 11:08am
226 Views
Post# 32568028

EAP vs. EUA

EAP vs. EUA
EAP: Sometimes called compassionate use, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

EUA: Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

EAP IRB approval: A bunch of accredited Dr's reviewed info and say it will benefit more than it will hurt. Dr's must fill out a form and have drug shipped. No media coverage.

EUA FDA approval: A bunch of accredited Dr's reviewed info and efficacy results, say it will benefit more than it will hurt. Drug is on the shelf in hospital. Lots of media coverage.
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