On February 22, 2018 RhoVac AB ("RhoVac") reported that it has held a positive pre-submission meeting with European Medicines Agency (EMA) (Press release, RhoVac, FEB 22, 2018, View Source [SID1234555938]). The meeting was the first step in company’s Scientific Advice procedure, which refers to planning for the further development of RhoVac’s RV001 cancer vaccine.
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In autumn 2017, RhoVac had a meeting with the European Medicines Agency. The primary conclusion of that meeting was that the EMA advised RhoVac to proceed with a Scientific Advice procedure to discuss continution of regulatory and clinical development of company’s cancer vaccine, RV001. In mid-January 2018, the company initiated this procedure, as had been advised. As a Small and Medium-sized Enterprise, SME, RhoVac is offered a pre-submission meeting to discuss the documentation to be submitted for the Scientific Advice procedure and to review the questions RhoVac wishes to address during the procedure.
RhoVac has now held this meeting with EMA. The meeting has ensured that the final documentation to be submitted to the EMA in the coming week, is adequate and well presented. The timetable for the Scientific Advice procedure is set by EMA. According to this schedule, the procedure will be completed by end of April 2018.