I am cautious about recruitment. I think if there are two clinical trials available using similar products, and one of those trials has FDA approval for a different subset of patients in the same condition (even though the trials are delivering the products at different stages), that will make recruitment for the other trial very difficult. What I am questioning now, though, is how long will it take for the adult trial to be approved?
The label extension perspective is interesting. I don't know exactly how it works, but if the FDA grants a label extension for Ryoncil for adults and children 12+, does that mean it is considered a standard of care? If it does, then it will not impact Cynata's trial recruitment rate, as all patients in Cynata's trial are eligible for standard of care based on their condition, it's just that half will also receive CYP-001. So I don't think this constitutes the horse bolting at all. On the other hand, if it does block the use of CYP-001 in the US (at least temporarily), we just revert to my opinion from the other day that this will simply add about a month to the estimated recruitment completion date (based on their forecast which we can fact check when the quarterly is released).
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I am cautious about recruitment. I think if there are two...
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