Ann: First USA site initiated in aGvHD trial, page-20

@JB1975

"Are these conga line of sites announced as opening as though opening a site itself was an achievement actually contracting on to the 50 50 split or to something else?"

Is your comment suggesting that some trial sites will not engage with the 50:50 randomised dosage split, but instead to some other ratio? If yes, that's a serious allegation to raise, and you would want to have a good body of evidence supporting this line of thought.

The vagueness (until what @pfeifer1982 unearthed the other day) regarding the clinical-to-placebo dosage split for this trial has been notable. It is possible that Cynata stalled to see how the FDA would handle MSB's second application for Rem-L, and what level of potency assays would be enough to meet the single-arm trial commercialisation pathway. Despite sending through a plethora of new matrix assays and long-term trial data, the FDA were clear for the second time that they required a well-controlled clinical trial to take their product into the market.

A randomised, well-controlled clinical trial is definitely more difficult to recruit patients into who are managing such a debilitating condition like aGvHD. Nevertheless, it is clear that this is necessary for FDA approval, so it is what it is.