Replies to post #492906 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

great stuff antihama! thanks.

[pqr]

antihama your reply is well outside of my very limited subject matter expertise however it seems to me that comparing Sotorasib (a targeted treatment and application) and DC-direct FDA approval is not an apples to apples but more an apples to alligator comparison what with the complexities of the P3 trial, historical
controls, pseudo progression, limited immunological precedent, and other material confounding factors. Aside from the resources brought to bear or not.

I’d happily settle for 2x of the Sotorasib approval process (4 months).

Hopefully you’re on to something here.

Thanks for your illuminating reply. Have a great evening.

[flipper44]

Excellent DD. Thanks.

[hoffmann6383]

fyi ex,

INN publication was April 2021 in this example. Obviously it doesn't matter.

have a good one buddy. by.

[eagle8]

Thank you antihama.
Appreciated.

GLTU

[scotty3371]

Amgen comparison is helpful..

[abeta]

- BTD – 12.8.20
- EUROPEAN COMMISSION APPROVES LUMYKRAS® - 1.10.22

Antihama -

So 13 months after BTD - we are approved and good to go -

Would you know if we can *currently* mfg anything in Germany -
from a bad memory - approval in Germany allowed any Euro-Union person
to enter Germany and use DCvax - if they could afford it.

Don't know if those rules still apply.

Thanks for your insight

regards

[hoffmann6383]

Sotorasib wasn't approved by the FDA until mid 2021, but still managed to attain $90m in revenue for FY21 with $45m (40 in USA, 5 RoW) coming in the Q4. In Q1 of 22 they had $62m (48 in USA and 14 RoW) in sales. DCVax-L sales could ramp quickly once approved :)

It all depends on if we are going for FDA approval in addition to MHRA. Quicker and more $$ in the USA.