No, the TLD doesn't address many of the key trial issues. First, PFS failed to meet the endpoint and then was tossed out. The unviability is the confounding of the data according to NWBO. NWBO also reported the naïve OS was confounded -- why would it be not "unviable" too??
The recurrent OS was post hoc data dredged data for a trial that was designed only for naive GBM. It is only 64 patients which is likely not sufficient size for an actual approval.
Then the original naive GBM used an internal comparator. Tossed that out (it was confounded too), and clinicians developed external comparators with big sample size to bias the p-values. But again we'll see how FDA responds to the that external comparator methodology.
Then there is the mystery FDA partial stop of the trial -- why was it stopped? NWBO has made no comment about why, but FDA doesn't stop a trial without serious issues.
These issues raise significant risk that first, the DCVax-L application will be accepted, and if it is, be approved based on this manipulated, data dredged post hoc data.
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