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Polynovo Channel 7, page-18

  1. 4,212 Posts.
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    I have had AVH (ReCell) shares for well over 10 years, like you @Rock57, I was a 'believer'. I thought surgeons were going to jump on ReCell and make me $Millions. But I waited and waited for years thinking surgeons have no reason not to use it, after all, it was safe, effective, no chance of rejection because it uses the patients own skin, and simple and easy to prepare and apply. There was, and  is, nothing like it. It was approved by the TGA to be used in Australia in 2006, and the EU not long after with lots of case studies and small pilot trials. Apparently the surgeons were saying to Avita that they need full randomized trials. It was lucky or good management that BARDA(with +us$100m) came on board in 2015 to fund the full FDA trials. Yes, even with BARDA support it has taken well over 3 years to FDA approval. We will know in the next 3 - 6 month what kind of up take there will be in the US, and how the FDA trial results will influence surgeons in other jurisdictions.
 
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