Mezzion Pharma announces that it has conducted a Type C Meeting with the FDA Regarding the TOP Line Data from the FUEL Phase 3 Clinical Trial
SEOUL, South Korea, Oct. 10, 2019 /PRNewswire/ -- Mezzion Pharma Co. Ltd. (140410: KOSDAQ) today announces that on Tuesday, October 8, 2019, Mezzion conducted the Type C meeting with the FDA in Silver Spring, Maryland.
The purpose of the Type C meeting was to receive FDA guidance on Mezzion's NDA submission. The meeting was very constructive, and the FDA was extremely helpful. Mezzion is now taking the necessary steps to prepare and submit an NDA based upon the results of the FUEL Phase 3 Clinical Trial and in accordance with the FDA's good guidance.
About Udenafil
Udenafil is a unique PDE5i drug that was used in the FUEL Phase 3 Clinical Trial to treat single ventricle congenital heart disease (SVHD) patients with Fontan physiology. The drug was administered as an oral 87.5 mg tablet twice daily.
Mezzion Pharma Co. Ltd.
Mezzion Pharma is headquartered in South Korea. Mezzion Pharma and its wholly owned subsidiary, Mezzion Pharmaceuticals, Inc., have administrative offices in Deerfield, Illinois and Boca Raton, Florida. Mezzion Pharma is an innovation-driven pharmaceutical company that is focused on discovering, developing and commercializing novel therapeutics in the field of rare pediatric diseases. Mezzion Pharma is a publicly-listed pharmaceutical company in Korea on the Korean stock exchange under (140410: KOSDAQ).
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts 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 by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Mezzion Pharma's expectations regarding the potential benefits of udenafil; Mezzion Pharma's expectations regarding the anticipated timing of any future clinical trials; Mezzion Pharma's expectations on regulatory submissions for marketing approval of udenafil for the treatment of Fontan patients to improve exercise capacity in the United States, including the timing of these submissions; and Mezzion Pharma's expectations regarding the potential commercial launch of udenafil, including the timing of a potential approval of udenafil. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Mezzion Pharma will need additional funds to finance its operations; Mezzion Pharma's or any of its collaborative partners' ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Mezzion Pharma's or any of its clinical trials will not be successful; Mezzion Pharma's dependence on the success of udenafil; Mezzion Pharma's reliance on third parties for the manufacture of Mezzion Pharma's udenafil and udenafil tablets; possible regulatory developments in the United States and foreign countries; and Mezzion Pharma's ability to attract and retain senior management personnel.
These and other risks and uncertainties are described more fully in Mezzion Pharma's most recent filings with the Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of Mezzion Pharma. All forward-looking statements contained in this press release speak only as of the date on which they were made. Mezzion undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Contact:
Mr. YT Song
Tel: +82 2 560 8011
Email: ytsong@mezzion.co.kr
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