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FDA Advises Adamis Pharmaceuticals To Expand Human Factors And Reliability To Support Its NDA For Epinephrine Injection


Adamis Pharmaceuticals Corp (NASDAQ: ADMP) revealed Monday it was advised by the FDA to expand its human study, as well as reliability student, i.e. product stress testing, to get its support for its NDA for Epinephrine injection. The medical regulator issued a complete response letter to it on Friday after the market closed.

Adamis Pharmaceuticals President and CEO, Dennis Carlo, stated, "We look forward to working with the FDA to resolve the remaining issues. Our goal is to submit the protocols for these studies to the FDA within a matter of weeks and begin the testing as soon as we receive their feedback. We are confident that we can deliver all of the data requested by FDA and will continue to work closely with the agency to facilitate their continued review of our NDA. Adamis remains committed to bringing the epinephrine PFS to market."

The company indicated that because of the improvements were made to the PFS in response to the FDA's original CRL dated March 27, 2015, theregulator indicated that in order to support approval of the product, it must expand its human factors study (patient usability) and reliability study (product stress testing), both of which were part of the final PFS NDA.

Adamis said it believes it could finalize the trial protocols with the FDA and complete the additional testing within a relatively short period of time at an immaterial cost, and submit the data back to the FDA sometime in the second half of 2016.

In the pre-market trading on Monday, the stock traded 25.5 percent down.

Posted-In: Biotech News FDA General


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