Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-5

You seem stressed.

TGA had probably indicated that they would not approve it without a randomised trial of some sort. In other words, they would not accept the criteria applied by the CE mark. It's not a reflection on the findings of their study - its a reflection of process.

So they pulled the application. They could've pushed the issue, filed appeals, etc etc, but decided to direct resources elsewhere in terms of approval, bearing in mind that you can get the treatment in Australia if your doctor wants it. They know they need an RCT, but there's no point running one that the TGA wants - they will run one that the FDA wants. So, let the FDA decide the terms of the trial.

Should the company have run a small RCT 6 years ago instead of what they did? Yes. That would've got past the TGA.

I know they are making inroads in the minds of doctors working with pancreatic cancer here in Australia. These docs are looking for something worth trying, and Oncosil is definitely proving at the least it is worth trying. Word of mouth will see doctors run externally funded investigator trials that will contribute to the registration process - so in that case the company gets revenue from selling product into those trials, and evidence for registration. That's what we've seen in Singapore, which is a funded "trial", and I suspect we will see that all over the world. And, each sale contributes to the patient registry which is also important for registration. They have Breakthrough Device Designation in EU and US too.

Of course the FDA is asking questions - that's what FDA does.

You can't deny that hospitals have closed their doors - I've seen it. They will open eventually and Oncosil will be able to demonstrate their product in EU.

As a prospective investor, ask: it is likely to go bust or be 5x from current 3.6 cents? Because frankly it has to be one or the other. If its gets HDE approval from FDA, I suspect it will triple.