Why AVH's sale in US is better than Europe and Asia, page-4

The simple reason why Avita has not had world wide acceptance IMHO and the company has mentioned this, is it has never completed a full randomized clinical trial. They attempted a FDA trial 4-5 years ago that failed because of poor design and management. They hoped that a KOL (key opinion leaders) program would be the pathway to success but only resulted in very little uptake in the EU. The UK's NICE knock back was another bad attempt and a set back. With BARDA support and getting them over the full PMA FDA line, things are turning around dramatically, an example is the last qrt sales figure, au$1.1m, they have never sold ReCell kits more than $0.5m in qrt before. Now that they have a full PMA FDA approval, they have a very convincing story to sell to surgeons and hospital admins from now on. The clues will be in the hospital uptake numbers.