Motif Bio (MTFB) , a UK-based clinical biopharmaceutical company, announced on Friday that it will meet with the US Food & Administration on 19 September 2019 to discuss trial work for its lead product, Iclaprim.
Iclaprim is the company’s leading product targeting acute bacterial skin and skin structure infections which affects more than 3.6 million patients in the US annually.
The AIM-listed company will discuss with regulators what additional clinical trial work is required prior to the antibiotic product receiving marketing approval in the US.
The minutes from a prior meeting with the FDA were discussed earlier in June and prompted the company to carry out a further trial to alleviate concerns about potential liver toxicity.
Shares jumped over 10% following the news.
Today’s announcement follows from the FDA’s encouragement for Motif Bio to put forth a proposal for a future study and review in July this year.
Official meeting minutes are received from the FDA typically within 30 days of a meeting. After this, Motif Bio will be in a position to provide an update to the market.
Additionally, the company confirmed it had received a deficiency notice from the Nasqaq stock exchange after not meeting the minimum bid price rule for continued listing. The company is now seeking to regain compliance within the 180 day period.
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