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Saturday, October 10, 2020 11:14:21 AM
“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.”
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