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Re: Hungry_Ghost post# 346673

Wednesday, 02/17/2021 4:06:27 PM

Wednesday, February 17, 2021 4:06:27 PM

Post# of 403078
Not necessarily, a ‘development’ could be a delay in trial start due to local IRB wanting more safety info.
Could be a delay in trial patient availability.
Could be a delay in getting B to trial sites.
Could be a catastrophic failure of B with a fatality that halted the trial (unlikely given B’s known safety profile across multiple trials).

I say these, as there are several more as well, and each can be listed as a material ‘development’ that requires “rewording” the filing.
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