BioCryst Pharmaceuticals, Inc. BCRX today announced that the
Biomedical Advanced Research and Development Authority (BARDA/HHS) has
released funding under the current $234.8 million contract to enable
completion of a New Drug Application (NDA) filing for intravenous (i.v.)
peramivir. BioCryst is seeking an indication for the treatment of acute
uncomplicated influenza and expects to submit the peramivir NDA by the end of
2013.
On June 28, BioCryst completed a pre-NDA meeting with the FDA regarding
peramivir. BioCryst reached agreement with FDA regarding all requirements for
a complete NDA submission.
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