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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.

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Motif Bio PLC Timeline

May 07 2019

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