They went with CE Mark as it did not require randomised trial with control. The FDA wil not relax that requirement and even if they recognise implants already made (which were not randomised), they will still have to find the balance of 300 patients in a trial. That will cost a shed load and recruitment will take ages- look how long it took to get just a few implants in the trail to date. Meanwhile there are safer, more targeted options for non-invasive external beam radiation therapy and they're marketed by huge multi-nationals, not pissy little firms from downunder.
Follow the money, Aston invented the device and throwing $40K to buy shares and stabilise the price a few weeks ago was nothing compared to what he has at stake in his 'baby'. Regardless of what happens with CE, for this firm to make any money whatsoever in the short or even medium term will require a large capital raising. It's been 6 years already...
OSL Price at posting:
6.0¢ Sentiment: Sell Disclosure: Not Held
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