well done jbaus! you worked it out, I've got him on $5 a fan...

well done jbaus! you worked it out, I've got him on $5 a fan post

I'll disagree with a few points.

Number 1) In the June presentation, Dan Kelly, as CEO, informed shareholders that they'll be recruiting patients into the pivotal trial
2) To start patients on a trial in the US using a class3 device, you need your IDE application ticked off.
3) It takes up to 30 days for the FDA to respond to an IDE application.
4) Ergo, the trial has been delayed (AGAIN) because the FDA still isn't happy with the pre-submission process. Surely OSL don't want a repeat of 2014, when OSL formally commenced the trial but didn't get IDE approval.
5) Read the 17 Jan 2014 update, regarding USA FDA gap analysis successfully complete. Now re-read it.

The IDE is nothing magical, it's just a little card that says you are free to import your medical device into the USA. The IDE requires less data than for CE marking (which takes about 2 months to process on account of the extra information required for your submission). So why on earth would any company go CE marking --> IDE ? when the reverse is quicker and there's less paperwork?
In late 2013, OSL apparently had enough (according to international medical, scientific and regulatory 'experts' [*cough* *cough* paid stooges]) data to flesh out an IDE submission... but for CE marking, they required even more work and more R&D spend to make a submission (ie. CE marking = importation and marketing licence; whereas an IDE is just for importing purposes). Again, why would you that? would you like me to spell it out for you?