BS 'The manipulation and lack of disclosure is disgraceful.' - it is not the market, it is OSL management and suggesting to punters that regulatory approval will only take a few weeks, back in September.
OSL have been very reticent in advising SH, but very quick to take legal action against anyone who calls them out.
Best.
OncoSil Medical's device scheduled for CE Mark Fast Track review
Thursday, September 10, 2015 by Proactive Investors
Clinical-stage Australian Lifesciences company OncoSil Medical (ASX:OSL) has been scheduled for a Conformité Européenne (CE) Mark Fast Track review for OncoSil™.
OncoSil™ is a localised radiation treatment for cancer, and is the company's lead product candidate.
There is also potential use for OncoSil™ in other solid tumours outside of pancreatic cancer.
A CE Mark is the mandatory regulatory designation required to commercially market and sell OncoSil™ in the European Union, and would be a company-making milestone.
Once received, this will open up a potentially sales pipeline allowing OncoSil to target the top five European markets of the UK, Germany, France, Italy and Spain.
In addition to these markets, OncoSil under the CE Mark licensing will also be able to target Australia, New Zealand, Singapore and Canada.
The company can then file for licensure in those countries.
The estimated world-wide market opportunity for OncoSil™ in pancreatic cancer exceeds US$1 billion.
Daniel Kenny, CEO for OncoSil, brings previous experience delivering the CE Mark process for other companies when he was based in Europe.
Kenny told Proactive Investors, "On two previous occasions I have worked through the CE Mark process for medical devices, and am very familiar with the process.
"And I am pleased to say that OncoSil is progressing in a way that I would have hoped for."
Kenny added, "Once you are in a fast-track review you would expect the full administrative process to take four to six weeks.
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It is now over 8 months since the above ANN. That is why the SP has gone no where, imo.
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