It is important to add, the fact that only 25 out of the 40 collected samples could be used was due to the patient population recruited initially ("Participants may have Grades C and D aGVHD involving the skin, liver and/or gastrointestinal (GI) tract or Grade B aGVHD involving the liver and/or GI tract, with or without concomitant skin disease." - https://clinicaltrials.gov/study/NCT02336230) vs. the high risk sub-group (based on MAGIC serum biomarkers, high risk, reflecting active gastrointestinal inflammation and high risk for 6-month NRM) of the sub-group that was filtered out as a result of prior Osiris/MSB trials - could be called a hindsight 20/20 insight.
This is where the FF delay may have not been entirely bad and may have saved us a some money running a trial that may have targeted too broad of a patient population, also potentially requiring a further sub-sub-subgroup post hoc analysis. Instead, the P2 trial is aiming to recruit: "HR-aGvHD must meet one of the following clinical features within 72 hours prior to randomization: (a) high-risk as per Refined Minnesota Criteria; OR (b) One of the following: (i) isolated stage 2 involvement of the lower GI tract; (ii) Stage 1 lower GI tract disease with skin involvement." https://clinicaltrials.gov/study/NCT05643638?term=cynata&city=&checkSpell=false&rank=1
Some may consider that "$50 million in near-term cash and stock and up to $50 million more in milestones" saved - if KK is correct.
(20min delay)