Less than 5% chance that the approval comes in September given how the minions are positioning and what we have seen in the public domain in terms of responses from MHRA, NICE, and posture (including details from 10-K in March, lack of ongoing commercial preparation, hiring) from NWBO.
It wouldn’t be surprising if we do not see approval this year. The minions are already pivoting towards Direct as the next big thing, LOL! So they are pushing L under the rug.
The highest likelihood (say 85%) is that they received major RFIs in Q1, 2025, or before. We could trace back to the last report from NWBO when they started putting the language that no interim updates will be provided by the company until the final decision on the application has been made. I think they added this language in their reports starting sometimes in the mid to second half of last year. They received major RFI just before then and haven’t been able to respond to all those concerns satisfactorily yet.
19-20 months for an application review and decision is extremely abnormal. So the chances of UK approval appear extremely low. No wonder minions are pivoting towards Direct now.
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