Hi Carmik, I have no timeframe for TGA approval aside from that at the AGM last year they said it would come AFTER FDA clearance. We have FDA clearance now so there's nothing holding the TGA back.
A hint perhaps that TGA approval will be soon….. Last year saw many surgeons apply through the APS to be able to use CardioCel prior to TGA approval. As we have not seen any surgeons granted this special access recently perhaps it is because full approval will be granted shortly so there is no need?
Anyway, nothing to hold the TGA back now, FDA (tick) CE Mark (tick) being used already across Australia (tick)
I'll predict TGA approval within 60 days.
Hi Carmik, I have no timeframe for TGA approval aside from that...
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