Replies to post #678346 on NorthWest Biotherapeutics Inc (NWBO)

[Zadie420]

Great points. Prof. flipper44 done it again.

[flipper44]

Oh, and

9. MHRA/NICE familiarity with decade old compassionate program.

[DJPele]

IMO, MHRA running behind will be the main factor of a late approval.

[Doc logic]

flipper44,

All great points and not disagreeing. I personally like the odds for a shortened time frame but that is NOT the guidance management gave us so I will not begrudge anyone who supports the idea of backing what management stated they expected. Hope is not the same as hype and I hope as you do that this gets an approval sooner rather than later for the very reasons you listed. Patients need and deserve the best effort possible with this. Best wishes.

[flipper44]

Edit: haha, I meant a well plead maa submission (not complaint)

I must have crossed a few neurons or something. 😅

[mike00h]

flipper44,
The senior administrators at MHRA do not want to screw up an approval and have to backtrack like the FDA and aducanumab (for Alzheimer’s).

Your item #8 reminded me that this sort of treatment has zero side effects. For any approving body, that plus showing actual improvement for a victim equates to ‘No-Downside’. For MHRA, an extremely prompt approval could not be criticized.
We are past 12 weeks so an RFI would have been issued by now, if there was going to be one.
I appreciate Smith’s opinion that it could be 3Q, but I see approval next week.

[dennisdave]

I admire your courage in trying to predict NWBO's timeline again after you have been proven wrong when it comes to predicting NWBO timelines many times before. Especially MIA comes to mind where you predicted the arrival of the certification 6 months earlier than reality.
I hope you are right but with all the inspections going on I have UK approval now in late September/ early October.

Im not a Hoffman fan but I do think he is right here

✅Potential Approval Timelines + Other Milestones✅$NWBO

In this post I'll speculate on some potential MHRA approval timelines for #DCVax-L and what other news we might see between now and approval.

Potential MAA Approval Timeline(s)

The National 150 day route, as I…

— hoffmann6383 (@hoffmann6383) March 13, 2024