Replies to post #592020 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

iclight,

The P3 data were validated by an independent peer review published in JAMA Oncology.

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



The interim PD1 combo data are significant too.

In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.

The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM.

https://www.fda.gov/media/120721/download




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



Bosch gave a great presentation recently. Here are some additional data highlights from the P3 and some additional data from compassionate use…

March 2023 presentation by Dr. Bosch:

http://nwbio.com/wp-content/uploads/NWBT-GBM-Summit-slides-3-15-23.pdf



The P3 was executed brilliantly and is more than adequate all by itself, but the application(s) for approval will require lots of paper clips and plenty of staples for all the extra pages that will be included—there is a voluminous catalog of supportive data that has been collected, analyzed, and validated.

All clinical data are relevant to a regulatory application including those data gathered from other studies, interim analyses, and compassionate use. All the DCVax-L trials have produced substantial safety and efficacy data, and two of the three clinical trials ran for over a decade with survivors alive today.

https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/




ASCO 2023

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171648758



https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials