Replies to post #611078 on NorthWest Biotherapeutics Inc (NWBO)

[churchill_21]

Nothing indicates a 2023 submission, they are making preparations for a submission, not "we are submitting in 2023". Also, FDA seems years out IMO, he was hesitant to even mention the FDA on the big biz show and he was pretty bullish on the other regulators, why not mention FDA if that is really the plan.

No need to rush the process here, they have 1.7 million pages, its going to take some time, may as well do it right.

[branster]

hoffmann, so what is your thoughts on timelines after submission in UK, I am getting confused on the approval timelines after CHM Meeting is scheduled and held.

[RobotDroid]

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.

[Doc logic]

hoffman6383,

The reality is and or logic dictates, that approval has likely been delayed by the addition of 700,000 pages and they wouldn’t have done this if they didn’t need to buy time for Edens and or regs, it would have been added in later. We ride the bottom rail, which is on a decent uptrend, until something changes. Best wishes.