This is really not that difficult to understand. If they want US approval for the device to treat pancreatic cancer they’ll need to do a pivotal trial. Panco isn’t sufficient for FDA- if it was then it would have already approved it like CE. A pivotal trial in this case almost certainly means a randomised control trial (RCT). Exactly how it’s designed, the arms that are compared in the trial and the trial size are things I guess they should be discussing with fda. They’ve had enough years to do that. if they do that trial and it’s successful then it’ll give them US approval for pancreatic and it’ll also give them strong data to convince agencies like NICE to pay for it. It’ll also give them strong enough data to become standard of care. There’s nothing guff about an RCT even if you think it is.
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