Ann: Mesoblast Phase 3 Chronic Heart Failure Results, page-349

The Q&A staff are generally pretty respectful, you'll see in the write ups over the next few days what they really think, and we are seeing that now with a general bearish short-term sentiment - lots of people who are trading in and out or watching the stock very risk-averse to the constant volatility. Some people just don't like seeing their paper profit/loss oscillate by 15% up and down on news, whereas we're all used to it by now!

On the FDA approval, SI was even more confident about GVHD approval by the FDA - and I KNOW everything must be taken in context, but I think we can only look at his belief as one piece of the puzzle. A better indication would be some kind of previous result where the FDA approved based on a secondary endpoint that was significant. Need one of our knowledgeable biotech people to dig around and have a look there - then assess how similar we are to that situation.

It could well be that covid gets EUA and approval, then CHF and maybe even GVHD afterwards. I would guess that again the FDA won't be too keen to bend the rules on an outright approval for CHF as the very first off the shelf MSC product that did not meet the primary endpoint, just because of the optics of the situation.

I agree with @stockrock on announcement timing. I posted on the weekend about news release this week:
https://hotcopper.com.au/threads/phase-3-dream-hf-1-read-out.5686234/?post_id=49537870