News Focus
News Focus
icon url

vator

12/27/21 12:24 PM

#429901 RE: LearningEveryTrade #429898

That is one reason why the SAP was changed and the LL suggested guidance for the FDA. It appears the FDA is changing their guidelines to reflect this change.

I think we are golden when it comes to that.
icon url

newman2021

12/27/21 12:28 PM

#429903 RE: LearningEveryTrade #429898

LL's slogan was 'Everyone is Living Longer'. This includes the crossover who took the vaccine after progression and these patients are called rGBM in the new secondary endpoint and are compared against respective external control that has an OS of less than 10 months. The JTM paper blended OS was 23months. Think hard.
icon url

flipper44

12/27/21 1:15 PM

#429924 RE: LearningEveryTrade #429898

How many times must it be discussed?

1. Dr. Liau states that most or all long lived patients have not evented.
2. That initially means little to no crossovers from placebo in that group.
3. Dr. Liau states it is important to get DCVax-l early in order to increase chance of long term survival.
4. Crossovers from placebo, whether misdiagnosed as psPD or correctly diagnosed as progressed, do not get DcVax-l early. They get it later than the treatment group, sometimes much later.
5. Idh-1 mutant tend toward pseudoprogression with SOC and live longer than real GBM (SOC) regardless of treatment beyond SOC, but these patients are no longer considered GBM, so no impact on trial if misdiagnosed as progressed.
6. DCVax-l does not tend to move the needle on IDH-1 mutant, so serendipitously benefits from global change in GBM definition.