some may think FDA meetings provide certainty, but in reality...

some may think FDA meetings provide certainty, but in reality they only provide feedback and guidance.. they don't tell you black and white what to do. That is for the applicant to decide. So in this situation, certainty is not attainable, so some will never be satisfied.

The usual caveat I am referring to is the phrase "we will receive formal minutes of the meeting in a few weeks". That is clearly missing from this announcement, which was drafted and released to the ASX following the meeting with the FDA.

Mesoblast typically either wait for the formal minutes to provide any update after a FDA meeting, or it they reference the meeting and draw any outcomes from that meeting, it is always followed by the above caveat of needing to wait for the formal minutes.

In this context, if there was any doubt or negative feedback from the FDA in that meeting... I don't think Mesoblast would have released the announcement, and if they did, they would have included the usual caveat that they would need to wait for formal minutes before proceeding. But no, they provided a statement that was as clear and confident as one can be in this situation, the use of the term ''appears" is all that Mesoblast can infer from a meeting from the FDA, as the only time the FDA will provide clarity is at the time of accepting the resubmission, and of course at approval or issuing another CRL.

At this point in time, the FDA can only provide feedback and guidance and for Mesoblast to take that feedback and guidance and do what they believe is the right course of action. As investors, we also need to make decisions to either shy away from risk or take on risk. Those who were conservative have done well in the past, but if Mesoblast make it to approval.. then everyone is a winner especially the children with SR-aGHVD who will have a much better chance of survival.

goodluck