News and Announcements
OncoSil Market Update; Commercialisation, Clinical and Corporate Highlights
- Published March 01, 2016 12:27PM UTC
- Publisher Wholesale Investor
- Categories Company Updates
1st March 2016, ASX Announcement
OncoSil Medical Limited (ASX: OSL) OncoSil Medical or the Company) provides the following update on its activities since the Quarterly Announcement on 28 January 2016.
Commercialisation
- The Company continues to be in active engagement with the Notified Body for the CE Mark submission. By way of additional background on the activities being undertaken in relation to the CE Mark;
- During January and February 2016, the Company is currently finalising a response with material it expects to be completed for submission to the Notified Body within the next two to three weeks;
- The Notified Body plans to schedule a face to face meeting with the Company as a means of addressing the material and any questions, as soon as practicable.
The time that the Notified Body may take to complete its final review and provide a recommendation is expected to be in the near term. The Company acknowledges that the CE Mark filing is complex and that the process has been complicated and taken longer than anticipated, partly because the pancreatic and liver cancer indication sought are part of a single CE Mark submission.
To read the full announcement, please click here.
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