Replies to post #686864 on NorthWest Biotherapeutics Inc (NWBO)

[User-840664]

<<<They got permission >>>
From Whom?
<<< very thoroughly vetted, externally proposed, expertized, blinded placebo based >>>
LOL, external controls were bogus! IMO and other scientist's opinion.
Are these the reasons they applied to FDA and EU for approval?? Clown. Your stock is barely holding 46 pennies

From the JAMA filing…
“Given the careful screening to include more favorable patients without signs of progression, we ask the authors to consider presenting complete data for the placebo arm for direct comparison as specified. Despite the urgent need for more effective therapies in glioblastoma, the absence of an ITT analysis suggests that this is a negative trial and that the reported findings are exploratory..”

Autologous tumor lysate-loaded dendritic cell vaccination (DCVax-L) in glioblastoma: Breakthrough or fata morgana? Preusser, 2023

"An initial report on the trial in 2018 reported only on the combined overall survival (OS) data of both study arms and failed to report on PFS, the primary study endpoint. The argument for not publishing the primary endpoint was an ambiguous statement about an expert panel being required because of the complex determination of progression.

Now, more than four years later, a second report is available, which is surprisingly named “A Phase 3 Prospective Externally Controlled Cohort Trial”. This is a remarkable title, as the investigators have re-analyzed the OS data of the study against published external controls and present this as a prospective trial. It is obvious, however, that this is not a prospective analysis but a post hoc retrospective analysis: the investigators had seen the data, both of their own study and of the cohorts taken for comparison and then decided to go ahead with cross-trial comparisons."

[User-840664]

Little man, do some real research....

No matter what anybody says, NWBO cannot get approval until they run the pediatric trials. This is from the EMA - same rules apply MHRA

"All applications for marketing authorization for new medicines in the EU must include the results of studies as described in an agreed pediatric investigation plan, unless the medicine is exempt because of a deferral or waiver." If a waiver, trials must begin after submission.

NWBO submitted a SAP for pediatric trials, which has been accepted. But until they run - or start to collect enough data to make a case - they are dead in the water. No matter what, they have to run pediatric trials ..... Where is the news that says the company is busy making that happen?

The only information is buried in the Form 10-K
Page 25:
"During 2023 the Company also devoted substantial efforts to preparations for launching the two required pediatric clinical trials."
There is nothing mentioned about enrollment or how she is going to pay for the TWO trials. There is this little note..
Page 10
"Late-stage clinical trials, such as our Phase III clinical trial for GBM patients, are especially expensive, typically requiring tens or hundreds of millions of dollars, and take years to reach their outcomes."