Unfortunately HC posters don’t get to decide what trials are needed or what regulators should do!
whatever term you use - phase 3 or pivotal -it’ll be needed if they want US marketing approval by FDA for pancreatic cancer. it’ll probably also be needed to supply stronger data more likely to convince public health systems to pay for it and oncologists to use device.
SRX actually had large phase 3 programme, FOXFIRE.
And I don’t see “marketing spin” being a winning commercial strategy here.
Media, page-16
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