They put very high controls on inclusion and exclusion criteria. They clearly want to generate clean data from the get go rather than do post hoc analysis to justify certain subsets. That was my feeling when I first read the trial protocol. Lot's of bloods to do before a patient can be included and you also have the 72 hr maximum window for being on a ventilator. So by the time you identify the patient, speak to the family to explain trial and obtain consent, do all the blood tests etc, there may be quite of few which miss the window. That's just the way it rolls in trials. Hopefully the final data set will identify exactly which of those inclusion/exclusion criteria matter so the approved indication will be less onerous.
I also think it takes a more time and effort to bring a site to trial readiness than what investors expect. The NY sites were all set up and were involved in the EAP and ready to go for full RCT trial but then they ran out of patients. MSB then had to identify, select more other high patient sites. There goes at least 1 month. Early on in a trial, each site needs to be monitored/audited to ensure they are complying to the protocols, not just for inclusion/exclusion criteria but for many other procedures including the prep and use of the MSC's. There's only so many qualified staff to do that monitoring. You don't want a site to have done 30 patients before they are audited. So it does take time to bring up each site to full efficiency.
MSB Price at posting:
$3.75 Sentiment: Buy Disclosure: Held
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