Thanks James. I think PR created the confusion regarding 30 working days. Without going back and checking I think he said that in his interview with 51Cap recently. Thanks for clarifying this and providing the official link.
Interesting to note that the only reason the FDA would step in during this grace period is if they believed research subjects were exposed to unreasonable risk by the trials. You would think this is a non-event when it comes to iPPS trials - which have been conducted without incident in several hundred cases already. The biggest risk our trial participants face is probably crossing the road to get to their clinic.
Looking forward to updates on trial recruitment from now on. The sooner we can recruit full cohorts the better.
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