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Biotech / Medical : NKTR Drug delivery Company
NKTR 17.23-1.6%Mar 27 4:00 PM EDT

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To: Miljenko Zuanic who wrote (490)8/28/2019 11:49:32 AM
From: ghmm  Read Replies (1) of 508
 
I guess technically I am not accurate in them saying it won't be met but how could they if previously they said an Adcom would be required and now say it won't happen before the 29th. Here is the exact language from the Q2 PR

ir.nektar.com

In July, for NKTR-181, Nektar received a General Advice Letter from FDA that stated that it is postponing product-specific advisory committee meetings for opioid analgesics, including the one previously scheduled for August 21, 2019 to discuss the NDA for the NKTR-181 product, while the agency continues to consider a number of scientific and policy issues relating to this class of drugs. The FDA indicated that it will continue to review the NDA for NKTR-181 according to the existing Prescription Drug User Fee Act ("PDUFA") timeline; however, because of the postponed Advisory Committee Meeting, it is possible the agency may not be able to meet the PDUFA goal date of August 29, 2019.

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