That's what I meant with HDE different to full/final FDA approval.
But they spend probably 3 year with single arm study which presumably wasn't useful for TGA but somehow was good for EU approval so new CEO "assumed" a week before TGA meeting to withdraw application which makes me suspicious that if TGA had approved the device similar to Hong Kong then probably it would been embarrassing for board who removed previous CEO. TGA withdrawal more the political decision then scientific IMO.
HDE approval highly dependent upon on data quality and justification provided with the application and also EU approval don't necessarily means FDA will also approve the device...IMO.
what is difficult to accept that no other hospital signed-up for the device similar to London clinic even though device is approved to use in EU for more than 6 months... !
it will be interesting time until 1st July as how the stock price move in absence of any news from company.. !
Any progress in marketing in UK?, page-10
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