Ann: Pancreatic cancer clinical study update, page-14

Hi Cafa,

Thanks for your response - very insightful.

BTG (Theraspheres) and Sirtex (SIR-Spheres) products both do their treatment from inside rather than externally. Their concept is very similar to Oncosil. In the case of BTG and Sirtex the radioactive spheres are administered into the blood vessels inside the catheter through a catheter. This has 2 issues (1) if tumour is not vascular and accessible from femoral artery, how do you get the spheres in place (2) when the spheres are administered, how do you keep them in place.

The beauty of Oncosil is that use of the product is not constricted by the vasculature. A skilled radiologist could place the beads exactly where they want them.  They also won't drift away in the blood stream. The successful placement of the beads in their previous trials (http://www.aspecthuntley.com.au/asxdata/20161110/pdf/01800686.pdf page 12) indicates it's possible and now their users have to work their way up the learning curve. Then I believe you will see complete response and partial response rates that far exceed current state of care. How hard can it be to endoscopically place beads in a tumour? elements like visualisation of the position, access, back pressure can all be solved.

So why haven't BTG and Sirtex looked at Oncosil's approach? I don't know but I'm pretty sure Oncosil will be featuring on their SWOT analyses possibly as a takeover target when it gets traction. From decades of developing pharmaceuticals and medical devices, I also know that big companies suffer from narrow vision. They invest their capital, knowledge and approach heavily into their proprietary technology and it's very difficult to switch from something you know. Look at the acquisitions big pharma are doing. They have huge R&D spend already, so why do they need to buy in the technology?

Success in the clinical trial is highly probable. They have proven the concept in previous trials and getting FDA IDE approval is not a trivial issue. They have to have been able to show FDA that the benefits of the treatment far outweigh the risks. That is, laboratory, animal and initial human trials showed that it will work with acceptable rate of side effects.

Are there really delays in product development process and CE certification? I think not - I believe that unrealistic expectations have been raised in shareholders and that's why it seems to be taking longer than it should. Again, in my experience, since the breast and hip implant disasters, FDA and CE certification notified bodies have become extremely cautious (even OTT) and require a lot more evidence to get marketing authorisation for a product than 5 years ago.

Youngun25, you asked why the directors aren't investing heavily? Are you sure about that. They have enough shares and options to ensure they will become very rich when this takes off. (see http://www.asx.com.au/asxpdf/20160912/pdf/43b3kydb2jx7b1.pdf page 19). It's in their interest to make it work.