Ann: Mesoblast Type A Meeting with FDA, page-22

Agreed - there really is no surprise. What I am encouraged by is the level of detail the company has disclosed. There is nothing that I think the company is hiding, as some have been in the habit of insinuating. As foreshadowed by Dr. Krause, it is all about demonstrating the trial product was standardised in such a way as to enable the trial evidence to be substantiated. The FDA is being meticulous (some may sau ridiculous), and so they should be - given the nature of cell therapies.

@crswin has posted an endpoints article about exactly how the FDA provided approval for another product which also proved similarly convoluted. What struck me was, it became two approvals in the end.

With these in mind, I think the logical thing that the company would be doing is to finalise the re-negotiation of the end date of the final-tranche loan drawdown (current expiry being end of Sep) with Oaktree. If they managed to do that, that might hold off a capital raising.