Yes. Very good news that the FDA has approved on-going access to the product. It certainly signals that they have little concern about the product from a patient safety point of view and they accept that clinicians in the US want to continue to use it with new patients. The risk of not being approved in the long run is getting vanishingly small.
The next big hurdle (and the one which will be very important to clear) IMO is getting to the point of reimbursement. I think management has their heads around this and will work through that process in a logical manner. That will be the big commercial driver in the US. GLTA
Ann: FDA Approves Continued Access to ReCell in US Burns Trial-AVH.AX, page-3
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