The D`Amarin Vascepa SPA resignation controversy as well as the reported low probability of reaching consensus with the FDA could threaten to reduce the perceived value of such agreements. The FDA updated the original SPA guideline in May 2016 and noted concerns about the withdrawal of SPA by noting that less than 1% of the more than 1,000 SPA agreements adopted since the passage of the Food and Drug Modernization Act of 1997 (FDAMA) have been repealed. The updated guide also specifies the FDA`s definition for “an essential scientific subject, essential for determining safety or efficacy,” for which the FDA is able to revoke an SPA agreement. Specific examples of key scientific issues include: ImmuPharma`s licensing partner for Lupuzor™, Avion Pharmaceuticals LLC (“Airplane”) submitted a Special Protocol Assessment (SPA) to the U.S. Food and Drug Administration (“FDA”). Spa is a process by which sponsors agree with the FDA on the design and size of clinical trials, in order to adequately meet the scientific and regulatory requirements of a study that could support marketing authorization. The previous Phase III clinical study of Lupuzor™ in SLE was also conducted as part of the ImmuPharma SPA. The verification period for an SPA application can be up to 45 days. JERSEY CITY, N.J., July 24, 2019 /PRNewswire/ — SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company that provides innovative therapies for difficult-to-treat and often fatal infections, announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) as part of a Special Protocol Assessment (SPA) on the design, study population, evaluation criteria and statistical analysis of the CANDLE trial, its critical Phase 3 clinical study with Ibrexaxaerp oral for the prevention of VVC relapse. This SPA agrees with the FDA that the design of the Phase 3 protocol takes due account of efficacy objectives that, if met, would provide the primary basis for authorizing oral ibrexafungerp to prevent recurrent VVC, an indication without FDA-approved treatment. In addition, a sub-study evaluating the efficacy of ibrexafungerp in the treatment of persistent acute VVC infections in VVC-reperation patients, who did not respond adequately to multiple doses of fluconazole, is included in the CANDLE study.

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