Okay Tryn2, let's use the potential times for MHRA inspection as a tool
to predict the time range for the MHRA decision.
1. Assuming that the 150 day clock started on March 7, the day of the
"confirmed validation". On May 10 (last Q date) we would only be
64 days into the process and it would have been premature to state
in the Q (May 10), that the company does not know when the MHRA
inspections will take place because such inspections take place more
than 80 days after the start of the clock. Yet NWBO did raise that question
In the May 10 Q. It is therefore unlikely that March 7 was the "clock start
date". It is also unreasonable to believe (IMHO) that prior to a 150 day
accelerated approval process, one would need 78 days to first determine
the validation of that MAA before proceeding to those 150 days (plus RFI?).
2. Assuming that the 150 day clock started on the day of MAA submission
(December 20 2023), than by May 10 (142 days thereafter), the MHRA
inspections should have taken place or the company should have been told
when approximately the delayed inspections will be initiated. I therefore doubt
that the clock started on December 20 although I cannot entirely dismiss that
date. If December 20 was the clock start date, we would be more than 190 days
into the process before the ASM and we could (though unlikely) receive a
decision before the ASM.
3. The most likely scenario is that the 150 day clock started on January 24, the
date of the initial MAA validation and 107 days before the May 10 Q was
published. It would not seem to me unusual that by the 27th day after the
80th day, the MHRA has not as yet set dates for the inspection(s) but it also
does not seem unusual that NWBO stated in its Q that they have not yet been
told when the inspection(s) will take place. I therefore believe that January 10
is the most likely clock start date and that we will receive an approval somewhere
between August and October.
Bullish
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