OncoSil Medical Ltd (ASX:OSL) is a late stage medical devices company focused on localised treatments for patients with pancreatic and liver cancer.
OncoSil said in its March 2016 quarterly update, that the company finalised detailed responses on all outstanding questions received by the Notified Body, for the CE Mark application for OncoSilTM in the European Union.
In follow up communications, the Notified Body has committed to holding a face to face meeting following review of OncoSil's latest data package.
OncoSil added that as a result of the recent interactions, the company remains confident in its submission for the CE Mark being granted and expects a final decision in the near-term.
A granting of the CE Mark would enable commercial sales to commence in the European Union and an application for TGA approval in Australia in 3Q 2016.
Daniel Kenny, CEO, commented:
“This last quarter has been an extraordinarily busy and productive time for the company.
"Our key focus in the shorter term is to achieve the CE Mark and enable commercial launch and first sales.
"We believe that the ongoing review process remains productive and collaborative.
"We remain optimistic about a favourable decision shortly on the CE Mark.
"The plans we have been putting in place internally, including the key management hires, should help us to be in a position to launch promptly, upon a favourable CE Mark decision.
"In addition, we view the IDE filing as a key step towards our longer term vision to be able to treat cancer patients with OncoSil in the world’s largest market, the United States.”
March quarter highlights:
- Finalised detailed responses for CE Mark to outstanding questions received from Notified Body;
- Dr Chris Roberts appointed non-executive director;
- Submitted detailed responses to US FDA Investigation Device Exemption (IDE) questions;
- Held productive face to face (Q Sub) meeting with US FDA regarding IDE submission;
- Completed $10.0m placement to Regal Funds Management; and
- Net Cash inflow of $8.6m for the Quarter and closing cash balance of $14.4m.
Preparations for commercial launch
OncoSil has also undertaken further activities in preparation for a commercial launch.
The company said: "During the quarter a great deal was achieved in Manufacturing Operations with the consolidation of alloying, atomisation & classification into a single dedicated facility in the UK.
"In addition de-novo production runs were also completed at this facility in January.
"We therefore believe that our Manufacturing Operations are all in readiness for commercial launch with inventory sufficient for several years of clinical trials and commercial sales.
"The company has also progressed its Investigation Device Exemption (IDE) with the FDA.
"During the quarter, the company submitted an additional data package of approximately 1,700 pages in response to FDA questions.
"In March, senior management and regulatory advisers met with the relevant Medical, Branch and Divisional Directors from the FDA.
"The company is also working to expand its investor relations activities and is pleased to report that Bell Potter Securities initiated research coverage during the quarter, in addition to continuing coverage from Wilson HTM and Van Leeuwenhoeck Institute."
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