Thanks for your responce.
"Adding "All enrolled subjects in this trial must receive corticosteroids at a minimum dose of oral prednisone 2 mg/kg/day (or methylprednisolone 1.6 mg/kg/day IV) as therapy for aGvHD for at least for 72 hours post enrollment" is in my opinion CYP's approach to standardise the P2 trial"
May be , however if that was the intent there should be a uper cut off point say 5 days.
I do understand that it would not be possible to enroll on presentation however as the Rux. trials that you sighted have a median of 2 days , earlier enrollment is achievable.
Bovine Serum Free is repeatedly reported as one of CYPs important properties yet it would be apararant that those responsible for the trial desighn are far from confident.
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- Ann: FDA Clears Cynata IND for Phase 2 Trial in GvHD
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cynata therapeutics limited
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Ann: FDA Clears Cynata IND for Phase 2 Trial in GvHD, page-66
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