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clock Created with Sketch. 20/03/18
19:42
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Originally posted by Interloping
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Well, not exactly starting from scratch. My understanding of that slide is that when TGA and other approvals were granted Avita did not yet have the peer reviewed trials that they have now completed and submitted for FDA approval. That means that burns doctors have in many cases not taken it up in clinical practice because they weren't sufficiently satisfied of its safety and efficacy.completed ) trials that were necessary to gain that approval should improve the success of marketing Recell in places like Australia that already have regulatory approval. This does seem to make sense of why Avita have leaned so heavily on the FDA application - something we've all been pretty critical of, I think.
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FDA approval doesn't equate to uptake in Au, EU, China fyi.
