Based on a recent meeting with the FDA, Adamis Pharmaceuticals (ADMP -13%) believes that it can generate the necessary data to support the resubmission of its marketing application next quarter for opioid overdose med Zimhi (high-dose naloxone injection).
The agency has requested additional Chemistry, Manufacturing and Controls (CMC) information, specifically extractables and leachables testing from the syringe and glassware.
Investors appear disappointed with the timeline.
Shares plummeted in November 2019 after the company disclosed the receipt of a CRL in response to its initial filing.
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