OncoSil Medical Ltd (ASX:OSL), a late stage medical device company focused on localised treatments for patients with pancreatic and liver cancer, has provided an update on its regulatory submissions.
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:
“We are delighted with the progress we have been making to prosecute and progress both our CE mark and IDE submissions.
"In particular, the filing today with the FDA is the culmination of an intense period of work by our team and advisers to prepare additional information in response to matters that have been raised in our Q-Submissions meeting and other interactions with the agency in recent months.
"While we had initially hoped this IDE process would be completed in the first half of 2016, we believe a positive outcome is still achievable in the near term.
"Our progress is also consistent with the FDA’s published data that for 2015 72% of IDE submissions were approved within two Q&A cycles.
"OncoSil is now concluding the first Q&A cycle.
"We understand that many of our shareholders and investors are eagerly awaiting both the CE mark and IDE and appreciate their ongoing patience as we progress through these two regulatory processes.”
ADDITIONAL DETAILS
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.
United States – Investigational Device Exemption
Today, the company filed an Investigational Device Exemption (IDE) Amendment with the U.S Food and Drug Administration (the FDA) for its planned global clinical study of the OncoSil™ for the treatment of pancreatic cancer.
This detailed submission followed ongoing and recent interactions with the FDA, the company and its advisers.
While there can be no guarantees, the company remains confident of a successful outcome with the FDA which it believes could be in the near term.
The IDE approval and the collection of the study data will be used to support a Premarket Approval (PMA) application and enable the company to commercialise OncoSil™ in the United States, one of the world’s largest healthcare markets.
Analysis
OncoSil is well-funded with $14 million in cash at the end of March 2016.
Broker WilsonHTM has placed a Speculative Buy with a 12 month price target $0.48 per share.
OSL Price at posting:
13.5¢ Sentiment: Buy Disclosure: Held
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