Don't consider selling before profitability, page-231

I'm also very optimistic on approval based on the same reason as Weazel. It's a tweak on an existing approved product. The output is essentially the same, however we're talking about a cell suspension so you'd need data around that. The company is claiming the variation in this output is less than before because the process is now automated and the human factor is removed so should be a good thing and the FDA likely sought clarification on this with additional data. Sounds routine and Avita certainly sound positive but nothing is 100% in this game.