But yet Dr. Liau, the NWBO Ph3 trial lead clinician, is using PFS as the lead efficacy endpoint for her NCI/UCLA Keytruda/ATL combo trial. Are you saying she's incompetent?
Funny how the PFS pseudo-progression only happened after DCVax-L failed to meet the PFS primary endpoint. Especially after Dr. Liau published a peer-reviewed journal article in 2018, over a decade after the trial started confirming the PFS primary endpoint of the trial. What happened from 2018 through 2021 when the PFS endpoint was thrown out as the primary endpoint
Regulators are going to have plenty of questions about tossing out the original protocol, replace it with a new protocol that included recurrent GBM that wasn't even part of the trial design from the beginning. Then the confounding of the naive OS that they are now using as the "new" primary endpoint. Going to be interesting to see how the FDA responds to the application based on the Phase 3 trial.
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