I did a bit more looking at this, as I thought the BMT CTN agreement only came into place post pediatric approval. But this was actually formalised in November 2023: https://cdn-api.markitdigital.com/apiman-gateway/CommSec/commsec-node-api/1.0/event/document/1410-02743357-7K2TI175J36S0SUO9AMMUHHUTG/pdf?access_token=0007yUgL7lHpSxNh48I5niAd1T4V
In that announcement, there was no requirement to wait for approval in pediatric SR-aGvHD to commence the trial. Yes, MSB is saving money because BMT CTN are funding the start up activities and MSB will only need to provide the cells. But this clearly demonstrates the time challenges of setting up US trials when you're relying on a third party to coordinate it. Cynata certainly found this out - it took 2.5 years to recruit their first patient in the P2 trial! How much longer will it take MSB to recruit their first patient? And will it realistically have any impact on Cynata's trial?
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I did a bit more looking at this, as I thought the BMT CTN...
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