Motif Bio initiates NDA rolling submission for Iclaprim and provides business update [Seeking Alpha]
MOTIF BIO PLC ADRS (MTFB)
US:NASDAQ Investor Relations:
ir.motifbio.com
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Source: Seeking Alpha
Motif Bio initiates NDA rolling submission for Iclaprim and provides business updateMotif Bio (NASDAQ:MTFB)initiates a rolling submission of a New Drug Application (NDA) to the FDA for iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure infections. The NDA submission is expected to be completed during Q2.Iclaprim has received Qualified Infectious Disease Product designation from the FDA together with Fast Track Designation. Upon acceptance for filing, iclaprim will receive Priority Review status resulting in a review period of up to six months. Upon NDA approval, iclaprim will be eligible for 10 years of market exclusivity in the U.S. starting from the date of first approval.Also, a small business waiver is granted to the Company resulting in exemption from the payment of $2.4M application fee for NDA submission.Motif Bio plans to issue its FY 2017 results by April 10.Click to subscribe to real-time analytics on
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