Forward-Looking Statements The statements in this press release about expected events or results are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to SCYNEXIS` ability to successfully develop and obtain FDA clearance for ibrexafungerp; the estimated costs of the studies and the date on which they could begin or be completed; and the dependence on SCYNEXIS on third parties in the conduct of SCYNEXIS clinical trials. These and other risks are described in more detail in SCYNEXIS` submissions to the Securities and Exchange Commission, including, but not limited to, the latest Annual Report, Form 10-K under the heading “Risk Factors” and other documents that were subsequently submitted to the Securities and Exchange Commission or the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date they were made. SCYNEXIS does not undertake to update such statements to reflect events or circumstances that occur after the date of their publication. A SPA agreement shows that the FDA agrees with the adequacy and acceptance of the entire protocol design, although it does not guarantee the FDA`s acceptance of a new drug authorization application or Biologics license application for the resulting proposed product, nor the approval of a marketing application. The controversy surrounding the repeal of the Amarin Vascepa SPA, coupled with the reported low probability of reaching a consensus with the FDA, could reduce the perceived value of such agreements. The FDA updated the SPA`s initial guidelines in May 2016 and responded to concerns about spa repeal by pointing out that less than 1% of the more than 1,000 SPA agreements concluded since the Food and Drug Modernization Act of 1997 (FDAMA) went into effect have been cancelled. The updated guidelines also clarify the FDA`s definition of a “critical scientific issue necessary for determining safety or efficacy” for which the FDA has the option of cancelling a SPA agreement. Specific examples of key scientific questions are: About Ibrexafungerp Ibrexafungerp [pronounced eye-BREX-ah-FUN-JERP] is an antifungal in the examination and the first representative of a new class of structurally different, triterpeneroid glucansynthase inhibitors.
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