The share price of Oncosil Medical Ltd (ASX: OSL) rocketed higher by over 20% today after the late-stage medical devices company announced that it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA).
After an intensive eight month process of submissions and interactions with the FDA, it now means the company can initiate a pivotal clinical investigation for OncoSil for the treatment of eligible subjects with pancreatic cancer.
The OncoPac-1 global study is intended to include up to 30 centres in the United States and other international markets including the United Kingdom, Europe, and of course Australia. A total of 300 subjects will be recruited with locally advanced unresectable adenocarcinoma of the pancreas.
The release went on to explain that the study is expected to enrol the first subject in early 2017 and recruitment is anticipated to take approximately two years, with each patient to be followed until disease progression. Subjects will then be followed for overall survival until death, or until the last enrolled study patient has completed 52-weeks of overall survival follow-up.
Whilst this is a very promising bit of news for Oncosil Medical and its shareholders, it will still be a long time before we see any notable results and financial gain from the study. I believe the company has just enough cash on hand to see it through the study, but it will be a tight affair.
At this point in time it is a little too speculative for my liking, but I would definitely suggest adding it to your watch list in order to stay up to date with its progress. In the meantime I would recommend taking a closer look at CSL Limited (ASX: CSL), Pro Medicus Limited (ASX: PME), and Sirtex Medical Limited (ASX: SRX) as alternative investments.
