2023 The Final Countdown, page-417

and seeing as mid cycle review is late

Just because the company hasn’t publicly announced that the mid-cycle review has occurred it doesn’t necessarily mean it hasn’t happened yet or is late ?


If I am being honest, I was surprised the company even announced the scheduled FDA inspection of Alonzo in Singapore and let’s not forget we never heard a word about the 74 day letter and we would have received one of them a while ago - good or bad


https://www.nasdaq.com/press-release/kempharm-receives-day-74-letter-for-kp415-nda-2020-05-19

KemPharm Receives Day-74 Letter for KP415 NDA


CELEBRATION, Fla., May 19, 2020 (GLOBE NEWSWIRE) -- KemPharm, Inc. (Nasdaq: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today confirmed that the Company has received a filing communication from the U.S. Food and Drug Administration (FDA), commonly known as the “Day-74 Letter.” The Day-74 Letter stated that the New Drug Application (NDA) for KP415 is sufficiently complete to permit a substantive review by the FDA, and that the target goal date under the Prescription Drug User Fee Act (PDUFA) is March 2, 2021. In addition, the Day-74 Letter indicated that the FDA is not currently planning to hold an advisory committee to discuss the KP415 NDA.


“As expected, the FDA has set the PDUFA date for March 2, 2021, and we are pleased that the regulatory process is proceeding based on the promulgated timeframes,” said Travis C. Mickle, Ph.D., President and CEO of KemPharm. “This is another important regulatory milestone for KP415, and we look forward to working together with our partners at GPC and Corium to support the regulatory process and commercial preparation activities needed to facilitate a potential launch in the second half of 2021, if approved.