RhoVac AB reports positive pre-submission meeting with the European Medicines Agency
22 February, 2018
RhoVac AB (“RhoVac”) announced today, 22nd February 2018, that it has held a positive pre-submission meeting with European Medicines Agency (EMA). 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.
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.
Comments from RhoVac’s CEO, Anders Ljungqvist
-We had a very interesting meeting with, as always, well-prepared EMA representatives. The discussion at this meeting provided answers to our questions and we received the guidance we needed to complete the documentation for the forthcoming Scientific Advice procedure.
For more information, please contact:
Anders Ljungqvist – CEO, RhoVac AB
Phone: +45 4083 2365
This is an English version of an original Swedish press release communicated by RhoVac AB. In case of interpretation issues or possible differences between the different versions, the Swedish version shall apply. This constitutes information that RhoVac AB is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on the 22 February 2018.
About RhoVac AB
RhoVac AB conducts research and development of immunotherapeutic drugs. The company’s main focus is the development of a therapeutic cancer vaccine with the potential to prevent or limit metastasis in cancer. RhoVac’s first drug candidate has completed pre-clinical phase and clinical phase I/II study has started spring 2017. RhoVac has its head office at Medicon Village in Lund, Sweden. The research has been conducted since 2007 primarily at the University Hospital in Herlev, Denmark, by a world-class research team in its niche. RhoVac is listed on AktieTorget, Sweden, a Multilateral Trading Facility (MTF), since March 2016. The share is traded under the ticker RHOVAC. Read more at www.rhovac.com.