Tuesday, July 18, 2023 11:07:32 AM
Yes, but from all I have read, submission is one thing, approval can be up to 150 days later? The various devices, combo's, etc all have differing timetables for completion AFTER submission, and according to NWBO they will only report acceptance, not the submissions. Where am I wrong on 2024?
Did you not say that 2023 would be our year previosly? Only trying to establish real timelines here, since nobody really knows if its a rolling submission, etc.
And now, after reading your reply to another, it seems 2024 is YOUR timeline.
See the SHORTEST timeline would take 230 days TOTAL (accelerated).
Also, see how when they say "150 days" application (clock stop excluded) it actually means ~14 months to 16 months .
This is the EU, I know it is not MHRA.
But it will be similar.
So, once NWBO submit, we need to wait 3 months before CHM meeting. Then clock start. At best, 230 days is 7 months and 20 days...
So it is impossible that NWBO gain MAA aproval before May 2024.
But clock stop with NWBO and the entire process will take longer than average of these timing. If it takes 14-16 month, this bring us to Dec 2024 to Feb 2025.
It is all there.
Did you not say that 2023 would be our year previosly? Only trying to establish real timelines here, since nobody really knows if its a rolling submission, etc.
And now, after reading your reply to another, it seems 2024 is YOUR timeline.
See the SHORTEST timeline would take 230 days TOTAL (accelerated).
Also, see how when they say "150 days" application (clock stop excluded) it actually means ~14 months to 16 months .
This is the EU, I know it is not MHRA.
But it will be similar.
So, once NWBO submit, we need to wait 3 months before CHM meeting. Then clock start. At best, 230 days is 7 months and 20 days...
So it is impossible that NWBO gain MAA aproval before May 2024.
But clock stop with NWBO and the entire process will take longer than average of these timing. If it takes 14-16 month, this bring us to Dec 2024 to Feb 2025.
It is all there.
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