NorthWest Biotherapeutics Inc (NWBO)

[seekinganswers]

Conclusion
This dendritic vaccine trial has several limitations. These limitations include changing the primary endpoint (OS instead of PFS), creating a new study population (recurrent glioblastoma), conducting unplanned analyses, using external controls in a design originally intended to be randomized, all changes occurring years after the trial finished enrollment. The selected external controls likely included patients with less favorable outcomes, which opposes the “fit-for-purpose” criteria usually applied in selecting external controls. Therefore, the purported survival benefit from the vaccine is unreliable. The accumulation of limitations, along with multiple changes made over nearly two decades; further hamper the reliability of the reported results. Without data sharing, those concerns cannot be alleviated. Glioblastoma is the most common primary brain tumor, and there is no valid reason to stray from the gold standard of a randomized-controlled trial with overall survival as the primary endpoint in order to change clinical practice. Dendritic cell vaccination is a very promising approach for GBM, the neuro-oncology medical community can only regret that due to the described DCVax-L trial weaknesses, we cannot draw any conclusions on potential efficacy.
https://www.sciencedirect.com/science/article/pii/S0035378723009190?via%3Dihu

PS....
"The Pediatric Investigation Plan (PIP)
Critically, this guidance builds upon existing regulatory precedent. In June 2022—well before the 2025 guideline—the MHRA approved NWBO’s Pediatric Investigation Plan (PIP) for DCVax-L."

That PIP trial design was rejected by field clinicians and is apparently being re written by NWBO,... No confirmation of the new trial design has been presented by NWBO , to date.

Stop posting lies!