Ann: FDA Grants Breakthrough Device Designation, page-11

JohnCohen- yes correct still need to do a full pivotal (randomised control) trial for FDA. The FDA website has good info about all this. From my reading There appears to be one particular advantage here that they could be allowed to base some of this on post market data which to me implies that OSL could for example start the pivotal trial, perhaps file for and get fda approval based on a pre-agreed milestone , and complete rest of trial following approval under some agreed conditions. So if all went well it could in theory speed up time to US market. However they still need to do a trial and it needs to be ultimately successful based on agreed endpoints is my take on this . To one of your earlier posts, whether they have the competence and depth of understanding of this disease to work through all this and design a study that could stand chance of succeeding is a consideration as they’ll get one shot only. Otherwise could be a very expensive fail.... Regarding time, I suppose logically could ballpark estimate possible timelines of any pivotal study assuming it’s in same population as panco, based on how long it took to get the 40-50 in panco, once OSL has divulged design of pivotal. US recruitment was poor I recall from earlier company Ann which wasn’t good sign.

where this Ann IS misleading is the implication that FDA has accepted osl device has significant advantage over other existing therapies. All OSL would need to offer up is the POTENTIAL for advantage, according to this FDA guidance. The fact they have this breakthrough still doesn’t make the device PROVEN relative to other therapies.
one last thing- this announcement says focus up to now has been on liver cancer. Really???? Have they done any trial work in this cancer, if yes when? What happen to CE mark for liver cancer announced long time ago and now seems buried? Anybody know??