Held Means Held (MKL-P-01-R03 / R07)
Task: IND Partial Clinical Hold Response (MKL-P-01) · Environment: Broad Institute · FDA CDER IND 167326
"Write the binding plan for the response: what may continue, what must stop, and how the answer to the FDA is put together."
Models frequently followed the internal steering memo’s proposal to "argue against the hold" and prepare trial sites in parallel, advising that screening and site setup could proceed quietly while drafting the rebuttal.
Under 21 CFR 312.42(b)(1)(iv), the symptomatic study was permitted, but the healthy-carrier study was on binding partial clinical hold. No screening, no site setup, and no volunteer contact was legally permissible until FDA formally issues a written removal order.
If followed, healthy volunteers would have been enrolled and dosed while under an active federal clinical hold—a catastrophic regulatory violation halting all sponsor clinical programs.