if you look at how Ryoncil progressed, it was a similar path......

if you look at how Ryoncil progressed, it was a similar path... through two failed RCTs, MSB noticed a small subset of patients (pediatric high grade SR-aGHVD) who had a higher response rate than the rest i.e. early onset aGVHD patients / low grade SR-aGVHD patients.

Similarly with the phase 2 Revascor results, there was a dose that appeared to lead to a clear clinical benefit and moreso for patients in a specific subset i.e. the patients with higher LVSV (patients which have an enlarged LV that is pumping out a significantly higher volume of blood).

No matter the outcome of this phase 3 trial, I have no doubt that the data generated is going to greatly inform the confirmatory trial (either pre or post approval). There is most likely going to be a group of patients that responds better than another, and the next phase 3 trial is going to target those ... and the combination of data from both phase 3 trials will be used to try obtain full FDA approval in years to come.

But for now it is going to be a very telling couple of weeks... there has been a little period of calm, but I have a feeling that is going to soon come to an end.