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There are no guarantees when it comes to the FDA"
I agree with your statement
@saltland, and thank you so much for your excellent post.
As an investor, I always think about the "what ifs". What if the FDA don't approve Recell Go at the next iteration, but ask further questions or require further tests? The only impact IMO is that the ongoing growth will be at a lower rate than it would have been with an approved Recell Go. But keep in mind that the growth rate now without Recell Go is around 50% and increasing. If anything, some potential buyers might be holding off for Recell Go, so the growth rate could have been higher if Recell Go was never brought into development.
Avita still has a huge competitive advantage by greatly minimising the size of any skin graft donor site. The benefits of this far outweigh the costs of using the existing ease-of-use device, including some training requirements. Reduced hospital stay times and better patient outcomes will ensure Avita continues to grow rapidly and achieve profitability some time during 2025 (on a quarterly basis). Indeed, the growth path for the existing device (in the absence of Recell Go) is enormous, given the indications now approved and the outlook for international expansion.
My investment is not dependent on approval of Recell Go. If it is approved during 2024, the future will be that much better again than my current investment case.
