MERLIN: of course there are “holes” , “gaps” or whatever word you prefer. An uncontrolled safety pilot study of n= 42 can’t possibly answer everything. Wilsons would say the same. If no holes/gaps , then there’s no need for any confirmatory trials ever again and FDA are wrong to want a future trial. I don’t think anybody is saying it’s not safe from this sample , it’s the proof of efficacy that‘s in the spotlight. Do you seriously believe just because of CE, this device is proven beyond doubt, it’s paradigm shifting Nobel prize winning unprecedented in the history of oncology, and Panco is some sort of groundbreaking landmark trial?? Do you genuinely believe all the claims made in this investor presentation deck and its perfect and error- free?? Oncosil met some standards set for CE marking no question , my hunch is with some latitude given because it’s an area of need (and maybe BSI didn’t want to get hassled by pancreas cancer charity lobbyists if they rejected it again!) . That’s it.
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