NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Gro,

Thanks for the reply 😶



I didn’t say that U.K. approval would “have bearing” on a decision by FDA, but I’m glad you raised that topic…

It is a noteworthy fact that 🇺🇸FDA chose to partner with 🇬🇧MHRA for Orbis & MHRA’s MAA decision is certainly relevant & will have global significance. The U.K. is a member nation of Orbis & approval would bode well for applications in other member nations. We all know that a BLA in the U.S. is the starting point for Orbis, but an initial approval in another country is still meaningful & important.

Aside from that, what I actually said in my reply to you was this: While the MAA review has been ongoing for 2 years, NWBO’s position is becoming more & more favorable in the U.S. because…

✅️ EDEN & Grade C capacity is advancing
✅️ U.S. regulatory environment is advancing
✅️ Other products are also advancing (Direct & aDC1)

Factors such as compassionate use patients & approval in other nations are not central to FDA’s review process, but they are unquestionably relevant.

Fud Flood 🌊