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Motif Bio submits a meeting request to the FDA concerning its iclaprim application to treat ABSSSI.

Read time: 1 mins
Last updated: 16th Jul 2019
Published: 16th Jul 2019
Source: Pharmawand

Motif Bio plc , announced that it has submitted a meeting request and package to the FDA related to the Company�s lead product candidate, iclaprim. In the minutes from a May 3, 2019, Type A meeting, the FDA indicated that an additional clinical trial will be required prior to granting marketing approval of iclaprim. The Company has been encouraged by the FDA to put forth a proposal for such a study.

Motif Bio has requested a Type B meeting with the Agency to discuss the proposed study population and design. The Company will provide guidance on when such a meeting will occur once FDA issues the meeting granted letter. The FDA typically schedules a Type B meeting within 60 days of request, although it can take longer.

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