NorthWest Biotherapeutics Inc (NWBO)

[User-840664]

JAMA IS NOT A REGULATORY AGENCY, NOR CAN THEY APPROVE ANYTHING!

JUNE 2023, just recently. . This is why your stock is tanking and there hasn't been an approval in over 20 years.. I. M. H. O. lol


When considering PFS data, the study is negative, and the trial did not reach its prospectively defined primary endpoint. Therefore, from a purely formal point of view, the study should be declared negative. *** Did they just say negative?***

The comparison of the investigational arm with an external control group should be considered a post-hoc retrospective analysis, suitable for generating hypotheses but not providing high-quality evidence. ***not providing high-quality evidence.*** -randomized externally controlled studies are gradually becoming attractive because they are faster, cheaper, and limit the number of patients exposed to substandard or ineffective interventions, but they are inadequate for a phase III trial and require a pre-specified detailed protocol and robust statistical methods to minimize the risk of bias

DCVax-L Vaccination in Patients with Glioblastoma: Real Promise or Negative Trial? The Debate Is Open


However, this study deserves some reflections regarding methodological issues related to the primary endpoint change, the long accrual period, and the suboptimal validity of the external control population used as the comparison arm.



https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10296384/