Replies to post #560252 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Thanks for the reply.

Yes, JAMA Oncology is the JAMA specialty journal that launched in recent years and was the most recent publication to publish Optune too.
JAMA Oncology is JAMA — it is the JAMA publication for cancer topics created because the JAMA Network is now organized by specialty in an effort to be more efficient and easier to navigate for a worldwide audience.





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

This whole video is awesome, but my favorite part is the brief mention of the pembrolizumab combo study at UCLA. Skip to about timestamp 6:30 of the video to hear Dr. Toms highlight the PD1 combo survival data!

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

[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/

[Reefrad]

Failed studies that are published don’t have titles and conclusions that they succeeded. You should read this manuscript again and focus on the conclusion. It’s pretty black and white.