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Re: Steady_T post# 769947

Saturday, 05/31/2025 2:32:26 PM

Saturday, May 31, 2025 2:32:26 PM

Post# of 823818

Hmmm. And a 4th possibility. The RFIs are multiple and taking a lot of time.


I said 7 months total responding. Does not matter how many.

By law, MHRA can issue as many RFIs as they wish, that is true regardless of the MHRA guidance that says only 2. So I agree there could be more than 2.

Yes, MHRA can always ask the CHM for an opinion. But that does not stop the clock thus does not change the timeline. OTOH, if the MHRA calls for a CHM opinion as required under the Human Medicine Act Schedule 11 Para 2, then the clock is stopped.

So again, either NWBO has taken a total of 7+ months, or CHM has the ball.

And we are not talking just longer than average for the time NWBO has taken to respond. We are getting into the redline on the tach.
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