Relief's lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale.
The related NRx CEO Update can be accessed through the following link. Therefore, the denial does not impede NRx's ability to seek drug approval, although it does identify areas where NRx needs to seek better scientific alignment with the FDA. Additionally, according to the CEO Update, the FDA has already granted priority and rolling review as part of the Fast Track Designation awarded in July 2020. NRx noted that BTD is not required for drug approval or emergency use authorization, but can afford faster review times, the ability to submit a rolling application, and dedicated FDA review personnel who may interact more frequently with the sponsor. Food and Drug Administration (" FDA") has denied Breakthrough Therapy Designation (" BTD") for aviptadil. (Nasdaq: NRXP) (" NRx"), has issued a CEO Update announcing that the U.S. Geneva, Switzerland, NovemRELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (" Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its collaboration partner, NRx Pharmaceuticals, Inc. Food and Drug Administration has Denied Breakthrough Designation for Aviptadil
Collaboration Partner has Announced the U.S.