Ann: OncoSil AGM CEO Presentation, page-22

"I have no idea how you could come to such a comment/question fourdollar."

Here's how Eey Ore:

I was previously a shareholder. These are some of my notes from when I first invested:

"FDA IDE approval was obtained in July-16 and OncoPac-1 was originally planned to be global and covering 300 patients with randomisation to chemo + Oncosil or chemo alone. It was since scaled down to be an "open label" trial of just 20 patients (given both Oncosil + chemo) of which 10 needed to be in the US and 10 could be external to the US. The company would still need to do massive randomised trials to get FDA approval. Oncosil is an implantable device that emits localised radiation treatment for pancreatic and primary liver cancer. Oncosil was a UK company previously called Enigma Therapeutics which was back-door listed in Australia in 2013. At the time of listing the product had been worked on for 10 years and had passed Phase2 clinical trials demonstrating safety. It was hoped that CE Mark approval could be obtained in 2013 and that the product could progress to a Phase3 trial"

My (albeit layman's) understanding is that randomised trials with sufficient statistical integrity need to be completed successfully in order for regulators like the FDA to accept that something has been "convincingly demonstrated".

If I were new to OSL and saw the comment made by the CEO, I might draw the conclusion that this had already happened. Given that the company has failed to achieve CE Mark (let alone FDA approval), I'm surprised he would make such a claim in an official ASX announcement.

I was actually hoping that someone more expert than me would be able to point to something in the recent announcements that made the claim more valid than it would have been prior to the announcements ...