its not the FDA's response its a lack of a response. They haven't shared details and I dont believe they really need to in any given timeline.
interestingly there is a few laws that govern this, I can't see anywhere a timeline on giving any reasoning to why, just whether it is on hold or approved (or no response which is approved)
see first and last bullet really, first bullet says they have to give a determination in 30 days. They did this, it was on hold. The last bullet says they need to promptly provide a written explanation for why. This is vague and subjective, so they don't need to do this in 30 days.
to me, if this is all accurate, its pretty clear that they can take as long as they like now.
- 21 CFR 312.20(c) states that the FDA “shall provide a written determination 30 days after FDA receives the IND or earlier” before any clinical investigation may proceed. this was completed we were notified of this June 10th
- 21 CFR 312.40 further explains that an IND automatically goes into effect 30 calendar days after receipt, unless the FDA places it on a clinical hold.
- Under 21 CFR § 312.42(d) — Explanation of basis for clinical hold:“Whenever the FDA imposes a clinical hold under this section, the FDA shall promptly provide the sponsor with a written explanation of the basis for the hold.”
(20min delay)