Replies to post #514189 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

LOL, bullshit. The change was seen on the EU trial registries much sooner than is stated here.

[biosectinvestor]

Your claim that the trial was "interventional" is neither proven nor meaningful. The fact is, the SAP was approved by the regulators and this trial actually started as a Phase 2, then was extended and increased. Along the trial route, there were changes, and your arguments don't really suggest anything to the contrary. Those changes were made with the approval of the regulators. Meanwhile, there is no way for you to prove anything suggesting that the SAP was not approved and there would need to be a massive conspiracy of universities, doctors, third-parties and others to make your narrative correct generally and factually, and that seems highly unlikely.

[SkyLimit2022]

The rGBM data are significant and a real breakthrough … Considering that there is absolutely nothing that extends survival for rGBM, DCVax is a miracle. Beyond doubling rGBM survival, it is safe and does not cause debilitating side effects. From a tax payer’s point of view, it is clear that the FDA and NIH are largely responsible for the development of DCVax … and from a common sense point of view, any rGBM patient would be outraged if told that this technology could not be approved for rGBM.

Who would not want DCVax at recurrence?

DCVax is a gem for rGBM, but rGBM is just the tip of the iceberg with this platform technology as cell science is certainly not limited to only one type of tumor.

"When we make a decision about approving a drug, it has to be patient centered. It can't be about the regulations"
—Richard Pazdur, MD

https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter

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

https://virtualtrials.org/dcvax.cfm

[meirluc]

The dredged recurrent 64 patient GBM arm will display an mOS of well over 24 months, far higher than the mOS of the recurrent ECAs. I wish for many more such dredged trial results that in the future will increase the survival of many more cancer patients

[SkyLimit2022]

Fact check:
These are the “types” that are posted on clinicaltrials.gov: “investigational” and “observational.” Either of these could be adaptive. To date, “adaptive” is not a distinct and separate “type” for any clinical trial in the U.S. in terms of the nature of studies as they are currently registered on the NIH clinical trial registry.

“Type”
describes the nature of a
clinical study. Study types
include interventional studies
(also called clinical trials),
and observational studies
(including patient registries)
and expanded access.

https://clinicaltrials.gov/ct2/about-studies/learn
https://virtualtrials.org/dcvax.cfm