|
 The U.S. Food and Drug Administration's decision on the company's
marketing application for Apadaz was conveyed via a complete
response letter.
Such letters typically outline concerns and conditions that must be
addressed to gain regulatory approval.
KemPharm said it is evaluating points raised in the letter and
intends to request a meeting with the FDA to discuss the way forward
for the drug.
Shares of KemPharm closed at $6.29 on Monday.
(Reporting by Shailesh Kuber in Bengaluru; Editing by Shounak
Dasgupta)
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