OncoSil Medical (ASX:OSL) said that it continues to be in active engagement with the Notified Body for the CE Mark submission.
Granting of the CE Mark would enable commercial sales to commence in the European Union, and application for TGA approval in Australia.
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.
The core focus of the company now is United States Food and Drug Administration (FDA) and CE Mark approval.
OncoSil update
- During January and February 2016, the company prepared detailed responses to outstanding questions received from the Notified Body. The company has been advised that the issues raised in three memoranda from the Notified Body have now been closed out;
- 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; and
- 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.
Timing
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.
Filing of the CE Mark is complex.
OncoSil said that the process has been complicated and taken longer than anticipated, partly because the pancreatic and liver cancer indications sought are part of a single CE Mark submission.
OncoSil added that it remains confident in its submission for CE Mark being granted, thereby enabling commercial sales to commence in the European Union and application for TGA approval in Australia.
Clinical
OncoSil is also actively pursuing its Investigation Device Exemption (IDE) with the FDA.
Corporate
Regal Funds Management recently became a substantial shareholder in the company, following the $10 million placement completed on 10 February 2016.
Analysis
The recent pull-back in the OncoSil share price to $0.145 provides investors with a lower entry point into the stock as it progresses towards the landmark CE Mark decision.
Research released today from Van Leeuwenhoek said: "We believe that OncoSil Medical is substantially undervalued at the current share price.
"Considering the upcoming CE Mark, OncoSil™’s much higher potential commercial success compared to Sirtex’ SIR-Spheres (with total annual sales of more than AUD 176 million) and the high unmet medical need in pancreatic and primary liver cancer, induces us to increase our valuation from our previous estimate of AUD 170-210 million and to calculate a more justified valuation of OncoSil™ of AUD 275-325 million or AUD 0.65-0.80 per share.
"This represents a substantial upside from the current share price."
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