On April 25, 2018 RhoVac AB (publ) ("RhoVac") reported that the company has received an invitation to meet with the European Medicines Agency (EMA) to further discuss a phase IIb clinical trial (Press release, RhoVac, APR 25, 2018, View Source [SID1234555936]).

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RhoVac initiated a Scientific Advice procedure with EMA immediately after completion of a pre-submission meeting end of February 2018; the procedure was originally estimated to be completed end of April 2018. Following invitation to participate at the EMA’s Scientific Advice Working Party’s meeting in London the entire procedure is, according to standard regulatory procedures, extended by approximately one month and completion is now estimated to be at the end of May 2018.

Invitation to a discussion meeting with the Working Party is not standard in a Scientific Advice procedure; however, EMA can provide this opportunity to a company to ensure that the development strategy of the company is fully understood and thereby to ensure that the most accurate advice is provided to the company for the design of the coming clinical phase IIb study.