KemPharm Completes KP415 Pre-NDA Meeting with FDA
KemPharm, Inc. (KMPH)
Last kempharm, inc. earnings: 2/28 07:30 am
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Source: GlobeNewswire
KP415 NDA Filing Anticipated in Late Q2 or Early Q3 2019 Conference Call Scheduled for Today, Thursday, April 11, 2019 at 5:00 p.m. ET CELEBRATION, Fla., April 11, 2019 (GLOBE NEWSWIRE) -- KemPharm, Inc. (Nasdaq: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the Company concluded a pre-New Drug Application ("NDA") meeting with the U.S. Food and Drug Administration ("FDA") for KP415, KemPharm’s investigational attention-deficit/hyperactivity disorder (ADHD) product candidate that contains serdexmethylphenidate (a prodrug of d-methylphenidate) and d-methylphenidate. Held yesterday, the purpose of the meeting was to discuss the Company’s NDA for KP415 and to confirm the clinical and non-clinical requirements for its submission. At the pre-NDA meeting, representatives from the FDA reviewed KemPharm’s summary of the data package being prepared for the KP415 NDA submission, including clinical, non-clin
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