How FDA approval takes Oncosil Medical Ltd closer to the Holy Grail

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.

Lastly, before you invest in any more shares I would highly recommend checking to see if you own any of these three rotten ASX shares. Having them in your portfolio could be damaging its growth potential, so they might be best swapped out if you ask me.

3 Rotten Shares to Sell, and 1 to Buy Today

After a double-digit rally for the ASX since 2016 lows, investors should be on high alert. You'll find a full rundown below of 3 shares we think you should avoid today plus one top pick worth buying, even if the market turns south and the RBA keeps rates at an "emergency low." Simply click here to uncover these stocks.

Motley Fool contributor James Mickleboro has no position in any stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.

Two New Stock Picks Every Month!

Not to alarm you, but you’re about to miss a very important event! Chief Investment Advisor Scott Phillips and his team at Motley Fool Share Advisor are about to reveal their latest official stock recommendation. The premium “buy alert” will be unveiled to members and you can be among the first to act on the tip.

Don’t let this opportunity pass you by – this is your chance to get in early!

Simply enter your email now to find out how you can get instant access.

By clicking this button, you agree to our Terms of Service and Privacy Policy. We will use your email address only to keep you informed about updates to our website and about other products and services we think might interest you. You can unsubscribe from Take Stock at anytime. Please refer to our Financial Services Guide (FSG) for more information.