CE Mark & IDE Progress

OncoSil Medical Ltd confident of a successful outcome with the FDA
Thursday, July 28, 2016 by Proactive Investors

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OncoSil Medical Ltd (ASX:OSL) has continued to make progress with its two key regulatory filings during the June quarter 2016, which remain the primary focus and value enablers for the OncoSil™ technology.

OncoSil's lead product is OncoSil™ with the first target indication being pancreatic cancer.

There is also potential use for OncoSil™ in other solid tumours outside of pancreatic cancer.

Daniel Kenny, CEO, commented:

“This second quarter has been another period of steady progress towards our immediate regulatory goals.

"The whole team including our VP of Regulatory, Nicole Wilson, has again put in a huge amount of work with both BSI on the CE mark and the FDA for our IDE, which we expect will result in successful determinations the near term.

"We remain highly focussed and driven to achieving both of these regulatory outcomes for our shareholders and stakeholders.”

Details for the June quarter

The company has continued to make progress with its two key regulatory filings during the June quarter, which remain the primary focus and value enablers for the OncoSil™ technology.

In May 2016, additional material was submitted to BSI, the company’s Notified Body, in support of its CE Mark application for the OncoSil™ product.

This submission addressed all questions requested from BSI to date and no additional follow up questions have been received since.

The company is seeking to expedite a response from BSI and remains confident of a successful outcome in its CE Mark, thus enabling commercial sales of OncoSil™ in the European Union and other non U.S. markets.

During the period, the company and its advisers also had ongoing interactions with the United States Food and Drug Administration (the FDA) following the Q-Submissions meeting in March.

Following on from this, the company lodged an Investigational Device Exemption (IDE) Amendment with the FDA on 30 June 2016, for the planned global clinical study of the OncoSil™ for the treatment of pancreatic cancer.

The company said that it remains confident of a successful outcome with the FDA which it believes could be in the near term.

The collection of data from the IDE study will be used to support a Premarket Approval application to the FDA and enable OncoSil™ to be commercialised in the United States, one of the world’s largest healthcare markets.