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Re: tiggerifficm4 post# 25864

Saturday, 10/10/2020 11:14:21 AM

Saturday, October 10, 2020 11:14:21 AM

Post# of 44690
Yeah it is just a strange way of wording what we already know. Checking out the definition of the Expanded Access Protocol.... “Expectant mothers” would fit under condition to gain access to an investigational medical product. The other article (Oct. 9) says “broadened use protocol,” but they are just talking about 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 ...Apr 27, 2020

https://www.fda.gov/news-events/public-health-focus/expanded-access


“The U.S. Food as well as Drug Administration (FDA) has actually given RELIEF THERAPEUTICS Holding AG as well as its U.S. companion NeuroRX, Inc. Broadened Access Protocol for therapy of Respiratory Failure in COVID-19 with RLF-100 (Aviptadil), an artificial kind of Vasoactive Intestinal Peptide (VIP). This activity makes the therapy readily available to people that have actually worn down common treatments as well as are not qualified for the existing Phase 2/3 scientific test of RLF-100 because of confounding clinical problems as well as particularly makes the therapy readily available to expectant ladies.”