Gekko - agree that it's a positive they're looking at another tumour type although not that surprising really as the device always had some sort of possibility in other cancers- they have some very old data in liver cancer after all. And they've had 5 years plus to look at this. But these announcements are always more interesting in my view for what they don't say. Is the fact they're going for this new cancer under the humanitarian process in US an acknowledgement that they've also actually admitted little chance of getting the much larger pancreas cancer indication any time soon in US? What happened to that big 300 patient randomised trial? They got IDE in, what, 2016....and how many were recruited in US. The announcement makes no mention of pancreas in US.
As for CE mark, yes sounds positive but we'll have to see what the clinical committee conclude again because as I understand it the core problem with the trial data is unchanged: everything stated as a 'good' result (survival, resection rate etc) could still plausibly be entirely the result of the much better chemotherapy they used as background in the trial. There's enough evidence out there to show that could well be true.
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