Per Investor Presentation ANN page 22 point 4 OncoSil has stated...

Per Investor Presentation ANN page 22 point 4 OncoSil has stated there is "Sufficient Clinical Data to Secure CE Mark in near term" - refer to page 22 point 4.

INDEPENDENT REGULATORY ASSESSMENT

Earlier this month TGA published DRAFT (for comment) clinical evidence guidelines document intended to assist Manufacturers and Local Sponsors ensure sufficient Clinical Evidence is available prior to application submission. These guidelines summarise existing GHTF and NB-Med requirements, which have been mandated in real-terms in Europe, Australia and Canada for (almost) as long as OncoSil has been around.
https://www.tga.gov.au/consultation/consultation-draft-clinical-evidence-guidelines-medical-devices

For those who don't want to read all 186 pages

-  At high level, there are 2 routes to acceptable Clinical Evidence; 1) ISO 14155 compliant pivotal clinical trials using the device for which approval is sought, and 2) ISO 14155 clinical trials completed on a predicate or similar device for which substantial equivalence has been demonstrated.
Note: Per ANN p6 OncoSil confirm "no other intra-tumoral device approved for PC"
Regulatory conclusion - no predicate or similar device exists for PC, therefore HC patients can't support PC indication and PC patient's can't support HCC indication

- Per TGA guidance document p43, specifically for high-risk devices, which OncoSil is, the preferred clinical investigation trial design is "a randomised controlled clinical trial ... Sponsors are advised to justify the patient number recruited according to sound scientific reasoning through statistical power calculation."
Note: Per ANN p5, 4 x pilot studies, 2 in PC (1 x 17 pts), 2 in HC (1 x 8 patients); from previous ANN's and publically available information, all non-randomised, non-controlled trials, with a combined patient # of approximately 40
Regulatory interpretation - clinical evidence is insufficient as 1) no RCT's have been completed, 2) patient numbers are too low to permit statistical power calculation

- Per ANN p19, sales in EU, Singapore, Canada and Australia on schedule for H1 2016
Regulatory interpretation- Canadian and Australian submissions are typically not filed  until AFTER CE approval is achieved. The current Health Canada and TGA review approval timelines are, conservatively, 9-12+ months, with a high percentage of rejections due to insufficient clinical evidence

- Per ANN p22 "Commence Clinical Investigation Onco-Pac-1 in H2 2016
Regulatory interpretation - fantastic, will be great to see the ANN for Ethics & Governance submission, and subsequently approval, come through in ... the near term ... ?

Independent Regulatory Conclusion
Ann = fluff and nonsense. Clinical evidence is insufficient to secure EU, Aus or Canadian approval in the near or far term.
A randomised controlled clinical trial with sufficient patient numbers will be mandated.

Per Ann page 4 - amended accordingly - Disclaimer
The views expressed in this assessment contain information derived from publically accessible sources that HAVE been independently verified. Global regulatory requirements support the accuracy, completeness and reliability of the information, and the likelihood of fulfilment of ... outcomes expressed or implied ... This assessment should not be relied on as a recommendation or forecast by poster. Nothing in this assessment constitutes regulatory advice.
Please do your own research.