News and Announcements
OncoSil Medical Regulatory Update June 2016
- Published July 04, 2016 2:40PM UTC
- Publisher Wholesale Investor
- Categories Company Updates
30th June 2016, ASX Announcement
OncoSil Medical Limited (ASX: OSL) (OncoSil Medical or the Company) a late stage medical device company focused on localised treatments for patients with pancreatic and liver cancer, is pleased to provide an update on its regulatory submissions.
European Union – CE Mark
The Company advises that in May 2016, it submitted further material in support of its CE Mark application for the OncoSil™ product in response to all requested questions received from the Notified Body, BSI, which is assessing the submission. Since then, no additional follow up questions have been received from BSI.
The Company remains confident of a successful outcome in its CE Mark which it believes could be in the near term, thus enabling to commencement of commercial sales of OncoSil™ in the European Union and application for commercialisation in Asia Pacific markets.
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