Ann: FDA Clears Cynata IND for Phase 2 Trial in GvHD, page-3

A few points worth mentioning here:

• "each participant will receive an IV infusion of 2 x 10^6 Cymerus MSCs/kg of body weight (up to a maximum of 200 million cells)" - on par with Cohort B in our P1 trial and significantly less than competitors - sign of confidence in the data obtained thus far
• "primary objective of the trial is to assess efficacy of CYP-001 in subjects with HR-aGvHD by Overall Response Rate (ORR) at Day 28"
• straight to P2 in the US (despite comments on here suggesting a P1 is still required)
• "at clinical centers in a number of countries, includuding the US and Australia", even though experts have claimed that AU is a developing country in the eyes of the almighty FDA
• "expected to commence enrolment by later this year" with "results expected early 2024"
  

Finally feeling the CYP Thursday vibes again!