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Fly News Breaks for November 26, 2019
ADMP
Nov 26, 2019 | 07:40 EDT
As previously reported, Raymond James analyst Elliot Wilbur downgraded Adamis Pharmaceuticals to Market Perform from Outperform following the disclosure of a complete response letter from the FDA on its high-dose naloxone product for opioid overdoses, ZIMHI. While issues raised by the FDA in Chemistry, Manufacturing and Controls "are almost always resolvable," Adamis doesn't have sufficient funding to carry it beyond the next 9-12 months, Wilbur tells investors. 95% of all CMC-related CRLs are eventually approved and a 9-12 month horizon for resubmission and approval "would fall in the range of feasible," Wilbur added, however.
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