Share Price and European Commercial Approval

i contacted Martin Rogers at Oncosil Medical after my recent windfall in Actinogen Medical in relation to the current share price and this was his response
I believe that this share is going much much higher and European Commercial Approval can only be around the corner

Dear XXXX

"Thank you for your email and support. The past 6 months in Actinogen Medical has been great with your and other investors support. The CEO Bill Ketelbey has truly delivered and it’s great to take the company to the next level.
On OncoSil Medical to answer your questions below
Regarding Dr Neil Frazer. Dr Frazer sadly left us mid last year for his personal family reasons. As you point out he is highly credentialed, however, you need a CEO who is 100% dedicated and as much as I begged Dr Frazer to stay he had to leave for his personal family reasons and could no longer stay in Australia. Sometimes in life family and personal reasons come first.
This left OncoSil Medical without a CEO for a period of long time in a critical zone of execution around meticulously detailed paperwork on both the first commercial approval of a CE Mark with the European regulators and with the IDE process with the US FDA regulators. This unexpected CEO departure left us with a delay of around 12 months since last year and perhaps the reason you mention for the soft shareprice.
As with Actinogen Medical we hired leading executive recruitment firm Derwent Executive and Dr Bill Ketelbey former Pfizer Australia CEO joined to Actinogen Medical, what a coup. We also used Derwent Executive to hire a CEO for OncoSil Medical. After a thorough and extensive search we found the most fantastic candidate for OncoSil Medical with Daniel Kenny(again another coup and I I will explain why in detail). There was a lot of interest with exceptionally high quality candidates. The board choose Daniel Kenny as he not only had 30 years’ experience in both the biotechnology and pharmaceutical sector and also with a stint on the other side working for the European regulator. Daniel Kenny was competent on many levels clinically and regulatory in what we needed but he had real edge for launching a commercial product in Europe and generating big sales. To give you an example the last medical device or a CE Mark product he launched has $400m a year in annual sales, which is significant in medical device or CE Mark sales. Daniel Kenny understands the key medical opinion leaders and how using these and other leavers to drive sales. Early EU sales along with sales in Australia, Canada and Singapore are a massive free kick before the US approval.
Daniel Kenny was very passionate about a superior way to treat pancreatic & liver cancer; OncoSil and working for safer ways to deliver radiation therapy. He was at the time working as an Aussie expat for a very big and growing biotech in Paris France and after pulling off a large business development executed deal for this company he wanted to come back to Sydney. Previously he worked in top senior executive roles for Baxter and Roche in Europe. In fact he already knew about OncoSil Medical before Derwent Executive approached him and he wanted to come back to Australia and make in his words “a massive success” of an Australian lifesciences company as a CEO. The fit was perfect for OncoSil Medical. In a way a perfect match was formed.
It has taken 3-5 months since Daniel Kenny has been appointed to get all of the meticulously detailed paperwork to be in order but we are now that I am proud to say back on track and looking better than ever.
Today’s announcement around ISO certification is a very solid step to obtaining a CE Mark with the European regulators. This would be the first commercial approval for OncoSil. You rightly point out that this both for pancreatic and primary liver cancer or HCC. OncoSil is different to other “brachytherapies” or localised radiation therapies. OncoSil Medical does have a unique worldwide patent in place. OncoSil works by a sticky particle of silica doped with radioactive phosphorous 32. This stays in at the point of injection at the tumour and is not embolised through the blood supply like other liver treatments and it is not a strand of beads like brachytherapy used for prostate cancer. Also P32 has a half-life of 14.3 days which is much superior in our experts’ opinion.
Nevertheless, there is a big demand for new ways to deliver safer localised treatment of radiation to the tumour and we believe OncoSil fits the role for this.
As you point out the CE Mark would be a big coup to get an early commercial approval in Europe for OncoSil in both pancreatic cancer and primary liver cancer or HCC. Our clinical evidence from four (4) international clinical trials using OncoSil will be the basis for the CE Mark application.
Today is a historic day for the company with the ISO certification before CE Mark. Our philosophy is to match great science around medical innovation to growing and unmet medical needs with good management. We expect today’s announcement to be the start of lot of newsflow in the next 3 -6 months and as you point out to repeat the success of investment for OncoSil Medical as what you have seen recently in Actinogen Medical."
Best regards, Martin