Having read most of the comments on the dozens of threads for...

Having read most of the comments on the dozens of threads for MSB since yesterday I am trying to crystalise some of the ideas put forward. It seems unlikely that the FDA have left to the very last moment a request to MSB for more information. There is no doubt the FDA have been inundated with additional work since March and so it is possible that timelines established many months ago have become a little blurred. In Mesoblast's case this has been complicated by the addition of a whole new trial using the same treatment (let's call it a drug) whose timelines for trial patients overlap the approval process. While MSB have previously documented their expectations of the COVID timetable, they may have only realised later the implications that an approval in the middle of the trial would have. Many here were surprised how slow the trial uptake was while others calmed the waters by saying it was following Mesoblast's timetable. Then we saw a move to activate Australia to the trial. While this was flagged early on in the trial design it was well in to the trial process before any patients here were administered. Was this in response to the need to get the trial moving quicker and have as many people dosed as possible before the Sept 30 approval date? Early October has been suggested as the timing for the second look at the COVID trial data (45% level) and may even be close to when all participants have received treatment.
The delay of a few days for Ryoncil approval may be to enable this to occur and not interfere with the trial. After all, who would want to sign up for a trial when there is a 50% chance you may receive the placebo (SOC) when the same newly approved drug is available off label. MSB have stated they want the trial to run to its full conclusion - if full dosing has not been achieved yet, there may not be a big rush to get that approval and 5 more days might just be what is required, with the overworked FDA happy to comply.