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Replies to post #227072 on Biotech Values
DewDiligence
02/19/20 11:36 AM
#228750 RE: DewDiligence #227072
On February 12, 2020, Adamis met with the agency to discuss the CRL, Adamis’ responses and to determine the best path forward for ZIMHI. At the face to face meeting, the Company obtained concurrence from the agency on the Chemistry, Manufacturing and Controls (CMC) information required for resubmission of the NDA. The additional information involves extractables and leachables testing from the syringe and glassware. In addition, the potential public health role of ZIMHI (high dose naloxone) in the current opioid epidemic was also discussed.