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H2R

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Alias Born 07/17/2014

H2R

Re: Sheadoggy post# 4155

Sunday, 03/26/2017 11:09:08 AM

Sunday, March 26, 2017 11:09:08 AM

Post# of 4817
wrt ADMP's EpiPen CRL + resubmittal, it does look like it may be approved earlier than ATRS. I don't know what that means in terms of ADMP PPS or conversely, ATRS future market shares for Epi.

Adamis Pharmaceuticals Announces FDA Acceptance of Resubmission of Its Epinephrine Pre-Filled Syringe NDA

SAN DIEGO, Jan. 19, 2017 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) (“Company” or “Adamis”) today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review the Company’s New Drug Application (“NDA”) for its Epinephrine Pre-filled Syringe (“PFS”) product candidate for the emergency treatment of anaphylaxis. Filed on December 15, 2016, the resubmission was intended to address the issues raised by the FDA in the agency’s June 2016 Complete Response Letter (“CRL”). The FDA indicated that it considered the resubmission to be a complete response to the CRL.


http://ir.adamispharmaceuticals.com/phoenix.zhtml?c=99350&p=irol-newsArticle&ID=2238418

On CRL, when FDA accepts the NDA for review, it takes around 6 months for the FDA to come around. So maybe in the June/July time frame for Adamis.

I cannot find an acceptance PR for ATRS. Does anyone have that date? Thanks

Kind regards