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PainChek General Discussion, page-13063

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AlCp

27,833 Posts.

1794

12/03/20

17:32

Post #: 43456042
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Originally posted by Golfboi ↑

I think where people are getting confused is with the differences between TGA & FDA approvals.

Generally speaking both have a heavy emphasis on safety of a product, But the FDA also looks at the effectiveness of a product where as the TGA doesn't really on this type of product.

I don`t believe there is a concrete threshold for the accuracy, but there needs to be some data to show that the product does what it claims. AKA isnt Disallowed & then consider how safe the product is when used it that manner & the overall net risk/reward so to speak.

IMHO RAP most likely failed as it didn't have enough data to show it works as claimed, PCK is a very different beast.

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https://crstodayeurope.com/articles/2015-feb/ce-mark-versus-fda-approval-which-system-has-it-right/

PCK Price at posting: 8.8¢ Sentiment: None Disclosure: Not Held
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Last 2.9¢		Change 0.001(3.57%)		Mkt cap ! $47.48M

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Price($)	Vol.	No.
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