FDA in CR#2 tells Mesoblast that they need to see evidence of X....

FDA in CR#2 tells Mesoblast that they need to see evidence of X.

In Type A meeting, FDA clarifies that the absence of X is the key reason why the FDA cannot yet approve the product. In fact without X, the clinical data you submitted cannot be used for approval because it is not considered an adequate study. You can either provide additional data from the phase 3 trial confirming you have X, or you must run another trial to obtain X.

Mesoblast go away and produce X from data from phase 3 trial, and provide it to the FDA and arrange another meeting with the FDA to check if what they provided was the X they were asking for.

Upon a high level review of X, the FDA advise Mesoblast that the clinical data provided by Mesoblast appears sufficient for resubmission.

now the FDA could do a detailed review of X and find that it was in fact Y, and send Mesoblast back with CRL #3. But they could also conclude that what they thought was X on initial high level review, is in fact X and thus are in a position to approve Ryoncil.

We will find out this calendar year if Mesoblast will get their first product approved by the FDA or not. Until then, nobody knows what the outcome will be. Educated guesses aplenty, likely to be affected by bias (me included) and motivated reasoning… but if we are not in the FDA meetings, it’s just conjecture.

goodluck all