"risk getting placebo"Important to note, the P2 trial is treating patients with "High-Risk Acute Graft Versus Host Disease" vs. patients with "Steroid-Refractory Acute Graft-Versus-Host" (P1).
P2:
https://clinicaltrials.gov/ct2/show/NCT05643638?term=cynata&draw=2&rank=1P1:
https://clinicaltrials.gov/ct2/show/NCT02923375?term=cynata&draw=2&rank=4Whilst this might sound the same, it isn't:
https://www.nature.com/articles/s41375-020-0804-2The Mayo Clinic lists the following (dated 09/10/20):
https://www.mayoclinic.org/medical-professionals/cancer/news/consensus-reached-on-initial-treatment-of-acute-graft-versus-host-disease-in-patients-who-receive-bone-marrow-transplant-nothing-definitive-yet-for-secondary-treatment/mac-20502381#:~:text=First%20line%20treatment%20of%20acute,gradually%20tapered%20off%20over%20time.
You can see that this is in line with the patients at "risk getting placebo":
If we were talking about second line treatment, then I'd agree with you (and Kurtzberg and MSB for that matter), but this is a first line treatment.
As discussed many times on here, the previous P1 trial aimed at safety, with signs of efficacy. You cannot expact a P1 trial to be designed the same way as a P3 (or even P2). Advancements here have been taken into account for the P2 trial, which can be seen here:
MAGIC guidelines used for assessing severity.
High-Risk only.
vs.
https://www.fda.gov/media/141131/downloadComparable results.
Also worth meantioning is the follow-up period:
"During the Follow-Up Period, subjects will have study visits up to 24 months."
(20min delay)