A bit more on the FDA, page-73

Don't be discouraged @pa31. It really is a significant announcement. Sure, the trial referred to in the ann is not a new one, despite the unfortunate insertion of that word "new" today. But until today we only had MSB's report of the trial results. Today we have the original scientific paper published in a reputable journal. Before publication it would have been vetted by scientific peers. This is independent validation that the results are believable. That is very encouraging for those who want this product to succeed (and that includes absolutely everybody with anatomical joints).

Full validation must await Phase 3 trial results but it's still very reassuring that every bit of evidence about this product to date is positive.