I would expect some solid news on the CE in the first 1/4 2016.
The IDE probably around mid year. I assume they have the trial already mapped out, and have a principle investigator lined up at one of the major US hospital systems. I'd expect, depending on the protocol, for them to be able to recruit over a 12/24 month period, with data about 8 months past last recruitment of last pt.
Thus I'd expect an application for a PMA around late 2018 / early 2019.
If they can convince the FDA to allow it,they may be able to get away with a much smaller trial, so maybe late 2017 could be on the cards fro the PMA application. They could then start to sell into the US whilst recruiting for a much larger trial to obtain clinical significance that may convince medcos to consider using the product.
OSL Price at posting:
15.5¢ Sentiment: None Disclosure: Not Held
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
(20min delay)