Ann: FDA Clears Cynata IND for Phase 2 Trial in GvHD, page-67

"May be , however if that was the intent there should be a uper cut off point say 5 days."

"HR-aGvHD must meet one of the following clinical features within 72 hours prior to randomization: [...]"
https://clinicaltrials.gov/ct2/show/NCT05643638?term=cynata&draw=2&rank=1

The trial design states "within 72 hours", plus the definition of HR-aGvHD is defined here as
"High risk acute GvHD refers to patients with newly diagnosed acute GvHD who have been identified as being likely to progress to steroid-resistant acute GvHD, based on pre-defined clinical features of the disease."
https://app.sharelinktechnologies.com/announcement/asx/22e43c44b51affdfed16a59e6a7666a5

Once all patients have been enrolled or when the Clinical Study Report is released, we will find out the median time for CYP's P2 trial.

As the past tense of the trial that took place in China may have given away, this is not a trial design published in advance, rather a summary of what has happened ("we used ruxolitinib", "Ruxolitinib was administered at a median of 2 days after" etc.).
https://clinicaltrials.gov/ct2/show/NCT04397367

A presentation published in September 2020 discussing the trial mentioned also noted the following:
"Ruxolitinib therapy was administered at 72 hours after corticosteroid therapy, based on MAGIC biomarker risk eligibility. (Ruxolitinib therapy was not administered until biomarker results were available.)"


https://www.astctjournal.org/article/S1083-8791(20)30577-2/fulltext

Noted, next time CYP should provide a median time in advance, based on recruited patients, but before recruiting patients to match the median time stated in the trial that took place in China, after all patients were enrolled.

Another compliment. Thank you.