Late to this, but it's surprising how blindsided many capable investors were by the resounding FDA Advisory Committee support for Ryoncil. As mentioned previously, Priority Review almost always ends up in approval (base rates, baby), and anyhow one of Mesoblast's usurers-of-last-resort had effectively made interest repayments contingent on approval (repayments only kicked in once US and European sales began). Lenders with 10%+ interest rates don't usually indulge desperate crapcos out of the goodness of their hearts. Moreover, the FDA briefing document was only about as adversarial as recent similar ones for treatments that were eventually approved.
From here, though, it's not clear to me what new buyers of the stock expect to see happen. Approval for Ryoncil’s tiny market does probably make it easier for Mesoblast to get approvals for wider applications and for other treatments too. But much of the market cap depends on a COVID treatment for which there is currently almost no evidence available. If the COVID trial goes belly-up, or the overdue Phase III trials come back with bad news, or the FDA decides to ask for more data there is plenty of downside in the current share price. An added problem is that in October - originally July but then the COVID news magically saved the day - Mesoblast needs to start paying back the very large principal to its other lender.
Disc: Sadly I sold as soon as the FDA briefing document was published, not having time that day to weight it up properly. I just couldn’t deal with the risk anymore, the latest red flag being the longstanding major shareholder selling down, a sale that has continued since. But as ever, taking profits can be where you lose the most money. Chalk this one up to bitter experience.