BioCryst (BCRX) Receives Prelim. Comment Letter from FDA for Peramivir

April 1, 2013 6:20 AM EDT Send to a Friend
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that it received
a preliminary comment letter from the U.S. Food & Drug Administration (FDA)
that outlines a pathway by which BioCryst could file a New Drug Application
(NDA) seeking regulatory approval of intravenous (i.v.) peramivir. The letter
was sent in response to questions BioCryst submitted to the FDA in advance of
an upcoming Type C regulatory meeting regarding i.v. peramivir. The FDA also
suggested the Company request a pre-NDA meeting to reach agreement on a
complete NDA submission and to address review issues identified in its
preliminary comment letter.

BioCryst also received written notification from the Department of Health and
Human Services in the form of a Stop-Work Order directing the Company to cease
work on peramivir under its U.S. Government contract, except for certain
activities primarily related to the upcoming FDA Type C meeting which is
scheduled. The notification confirmed that the Biomedical Advanced Research
and Development Authority (BARDA/HHS) will continue to support and fund
certain activities that are necessary to achieve immediate milestones, as well
as activities deemed essential to maintain compliance with FDA regulations or
to fulfill pending FDA requests. Following an In-Process Review (IPR) meeting,
which BioCryst anticipates in the second quarter, BARDA/HHS is expected to
determine the path forward for the contract.


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