CE Mark Odds, page-53

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Gekkowolf

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08/09/19

13:17

Post #: 40353092
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Originally posted by whytee: ↑

"OSL goes one better and submits 42 patient study. Over double what was asked. The study shows the device is safe and it works"

Well the crux of the matter might well be that BSI says the study (even with 42 patients) doesn't "prove its safe and it works". One problem is that almost certainly its an open design and another would be (which is probably the main point) is that treatment patients weren't necessarily matched to controls, in other words its not possible to accurately say the diseases in both arms were the same. That would create a level of uncertainty that can likely only be addressed by a new and better trial.

However as Cafa pointed out, the company may still be able to build a business without certification of the treatment. Just going to be very much more difficult.

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Whytee,

The protocols for the study were approved by BSI.

End of story! But no BSI has to change the rules of the game, over and over again.

That’s the crux of the matter! Now tell your insto mates to stop trying to get stock on the cheap!

OSL Price at posting: 7.9¢ Sentiment: Hold Disclosure: Held
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