Proactive Investors - Run By Investors For Investors

Motif Bio meets FDA

The company expects to be furnished with minutes from its meeting in the next 30 days, allowing it to chart a path for its lead drug
Motif Bio meets FDA
The company met with US regulatory authorities

Motif Bio PLC (LON:MTFB, NASDAQ:MTFB) is expected to be able to chart a “path forward” for its lead drug iclaprim in the next month after a meeting with the US regulator went ahead as planned.

The company sought talks after the Food & Drug Administration declined to give the antibiotic the green light, citing in a document the need for additional data on liver toxicity.

As one of Motif’s advisers pointed out, this wasn’t a straight ‘no’.The firm has always said it was keen to discuss potential deficiencies with the information provided.

The latest meeting offered that chance, with feedback expected in the next 30 days.

“After Motif Bio has received the [FDA’s] minutes, the company will be in a position to provide an update to the market on the path forward for iclaprim,” the company said in a short investor update.

iclaprim is being developed as a treatment for acute skin infection.

View full MTFB profile View Profile

Motif Bio PLC Timeline

Newswire
May 07 2019

Related Articles

scientist in lab
February 25 2019
Results from a 62-patient follow-up study are due shortly, while data from a 500-person-strong managed access programme should be available by the end of next year
scientist in a lab
April 12 2019
Danish giant Novo Nordisk recently signed up to use its NDD platform, and bosses expect more collaboration deals in the coming months
technician's in a lab clean-room
March 12 2019
The Maryland company is seeing revenue surge through an expansion of contract manufacturing services, particularly in the area of CAR T-cell therapies

© Proactive Investors 2019

Proactive Investors Limited, trading as “Proactiveinvestors United Kingdom”, is Authorised and regulated by the Financial Conduct Authority.
Registered in England with Company Registration number 05639690. Group VAT registration number 872070825 FCA Registration number 559082. You can contact us here.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use