Replies to post #588065 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

iclight,

The control arm is a placebo group and the participants in the placebo group are receiving murcidencel (DCVax-L).

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

Verify what you find posted online and seek trustworthy full-context sources.

The combo data are significant.




Bosch gave a great presentation last month. 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 brilliantly executed 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/

[hoffmann6383]

bullshit insinuations. 2/3 of Oncology trials approved do not have a placebo arm. see chart

$NWBO

External controls in oncology indications are the norm at the FDA. Period.

"Pivotal trials supporting oncology approvals were much more likely to use a historical control than nononcology approvals (13 [72.2%] vs 8 [14.0%]; P < .001)..."https://t.co/CPyohBztFI pic.twitter.com/ap41RUpvVb

— Hoffmann (@hoffmann6383) April 21, 2023