NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Surprisingly, I kind of agree with you for once. I do agree with you about the importance of having a completed P3, and of course believe that murcidencel will be approved by all the RAs based on the exemplary P3 alone. The P3 was a monumental achievement. I just think it is awesome and extremely rare for a new drug candidate to have years of safety and efficacy data from two additional successful and ongoing trials.

I see those other combo studies as an insurance policy and extra motivation for RAs to act swiftly.

Consider these facts (and there are many more):

1. Awesome P3 results confirmed by independent peer review

2. Astonishing interim survival data in combo studies (PD1 and ICLC)

3. Trial data gathered from both external control comparison and from internal placebo controls for combo investigations

4. Unmet need in rGBM (and nGBN)

5. rGBM efficacy data for murcidencel alone and far greater rGBM efficacy data in combo

6. Cell-based platform potential beyond GBM

7. NIH support

8. Lots of focused time and attention from those seeking to discredit the breakthrough achievement (always a good sign when competitors indicate that a formidable threat has emerged)

9. Exceptional safety/toxicity profile

10. NICE

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

https://clinicaltrials.gov/ct2/show/NCT04201873

https://www.nice.org.uk/guidance/indevelopment/gid-ta10143

https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/