Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-123

Not news to anyone but the FDA accepted all previous submissions that all resulted in CRLs... sorry to burst people's bubbles.

What concerns me here is that the previous CRL requested a phase 4 confirmation trial which has been ignored by Mesoblast. I know some will point to the interactions with FDA subsequently that seem to indicate that the FDA have somehow changed their stance on that but that information hasn't actually been released to market so it is just conjecture.

This is second worst case scenario but if this submission results in another CRL then the CEO should be removed for ignoring the previous CRL. Worst case scenario is an outright rejection.

For anyone who wants to paint this a "downramp", I'd like to say I have a lost a lot of money on this stock and have a lot riding on its success. I am holding lead balloons here, all because, from what I can see from the outside, has been a lot of poor decisions by the CEO.

I wish all the best for this but let's also eat some realism pie here...