- Motif 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.
- Now read: Biohaven Pharmaceutical (BHVN) Presents At Needham And Company 17th Annual Healthcare Conference - Slideshow
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