Replies to post #463463 on NorthWest Biotherapeutics Inc (NWBO)

[CherryTree1]

That would be true that if we were tying to show that median survival was just slightly better with DCVAX say 2 months better like they did with the current SOC then completely agree not having a placebo control group randomly chosen from the full set of patients enrolled to the same criteria is problematic.

But that is not what we have here. There is such a eyepopping significant survival different between SOC and DCVAX it is no problem what so ever even if you discount a large number of the SOC historical population. you will still have a 2X - 3X overall survival improvement not 2 months but years of difference.

Again from the still blinded data on all 331 patients
https://nwbio.com/updated-interim-data-from-phase-3-trial-of-dcvax-l-for-glioblastoma/
Survival at 3 years is 28.2%
Survival at 3 years for 41.1% (methylated)

The historical GBM SOC survival
https://www.nature.com/articles/s41598-020-68011-4#:~:text=%25%2C%20respectively36.-,Discussion,glioblastoma%20during%20or%20after%202005.
3-year survival was 11%,
and 5-year survival was 4%
The recent historical SOC GBM survival curves from many different sources are all pretty much dead on.

[hoffmann6383]

TLD is likely to drop in the next month and the results will lead to RA approval in short order.

I agree Ex. by.

[Dr Bala]

Irrelevant in light of LL's talk at the University of Miami on April 1. Your post is in disagreement with her talk.

[Lykiri]

Randomized trials can selectively enroll. But to then compare against historical norms is an issue. Trials DESIGNED to be compared to historical norms will be DESIGNED to have matched patients.

At least that is what Dr Pazdur says.

exwannabe,

I don't think it's an issue for the FDA. Here's a good example:
SNO 2020 Think Tank on Neuro-Oncology Clinical Trials-November 6, 2020.
Slide at 6:46:03

Medicenna recruited an eligibility matched control group for comparison against outcome of the Phase 2b study.
Subjects recruited in ECA were identified from patient registries at two major neurosurgery centers with access to GBM tumor tissue banks under IRB-approved protocols.
In order to avoid potential bias, Medicenna was blinded to the survival data throughout the project.
An expert group in regulatory statistics and real-word data (Acorn AI) was contracted to analyze the data employing propensity score weighting methodology to adjust for baseline differences in the 2 groups (i.e. MDNA55 versus ECA)

[highwayman4life]

Now that's some funny $hit!!

In a long list of this trial is a scam, they cherry-picked blah blah blah, the new argument will be, "how dare the FDA allow NWBO to compare their TLD against historical norms."

The word Ex seems fitting here:-)