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Thankyou cgt2009 for this link ... a lot is explained ... dated 24th October 2018...
I have scanned those parts which seemed relevant to Cardiocell and feel that there must be a good chance that we will (eventually) get TGA approval.
There was even a site inspection of our Malaga facility by one of the cardiothoracic surgeons in company with Prof Neethling which was reported as being OK in outcome
Iceman ... whilst a product name was not mentioned, there was reference to prior types of patch and calcification.
This is a huge effort of investigation by those concerned and has taken years ...
I would expect that the TGA would not issue any approval until they see what the Qld Coroner says , and the report was only released a couple of weeks ago.
Fingers crossed regarding Cardiocall, but also spare a moment for the poor little kid who died ... and his loving family.
Wilbo... did Wayne say anything about future prospects for TGA approval? ... Timeline?
D
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