Clinical-stage Australian Lifesciences company OncoSil Medical (ASX:OSL) has been a strong performer on the Australian Securities Exchange in recent weeks.
Intra-day today the company is 6.4% firmer at $0.25 on strong volume of circa 700,000 shares traded.
A month ago the company was trading in the $0.15 to $0.17 range.
Go back almost a year when Daniel Kenny was first appointed CEO, and the shares could have been snapped up for under $0.07.
That makes the company a 3.5 bagger since Kenny came on board.
Earlier in the month the company filed an Investigational Device Exemption (IDE) with the US Food and Drug Administration (FDA) for its lead product candidate, the OncoSil™ localised radiation treatment for cancer.
This is a significant milestone in the development pathway for OncoSil™ in pancreatic cancer and is the first step towards securing FDA commercial approval for OncoSil™ under a Pre-market Approval (PMA).
At the time, Kenny, commented:
“I am delighted to report that we have filed our Investigational Device Exemption submission with the US FDA.
"This represents a key milestone in the development timeline for OncoSil™ in the USA.
"In conjunction with our ongoing CE Mark process with the European regulator, the company now has an active global regulatory licensing pathway.”
How OncoSil™ works
OncoSil™ is an implantable nuclear medicine (radiotherapy) device that has been successfully piloted in pancreatic and liver cancer.
The device is inserted directly into the centre of the tumour using well established technology.
OncoSil™ has clinically demonstrated target tumour regression (tumour shrinkage) in both solid tumour indications of pancreatic and liver cancer.
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