Totally agree, wise to be at least a bit cautious - significant credibility issues in the past with similar tone of announcements and accompanying excitement, and also in the present with the claims being made in public about the device (“ superior to comparators “ and “ prolonged survival” ) which are very likely to be found out once they’re out there selling this product to oncologists . But maybe this time they have won over BSI.
Also I thought PMCF referred to the future clinical trials they’d have to do to prove the device actually has efficacy as at present it’s unproven, and confirm the safety shown in panco but this ANN seems implies it’s about commercial plans which I’d not have thought would be the interest of the regulator.
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