Yes, it should dawn on folks that what I have said all along has been accurate -- 100% so. A confirmation is always used when suspicion of pseudoprogression is at play. Spelled out, crystal clear that nGBM gross total resection patients often have changes in earlier MRI readings that do not signify tumor -- follow-up and monitor scans. Should note, that hasn't changed, as it was something they starting doing from observations that bringing chemotherapy upfront with radiation caused a phenomenon to occur earlier.
Also, years ago I noted that this Phase III trials baseline (Post Radiation MRI) was a very superior start time to begin monitoring response. Many of the changes associates with other GBM standard of care variables are reduced at that time point (go down as adjuvant chemotherapy continue). But there will be psuedos that make it into the main arm like I stated too. And now it seems that it is recommended that all newly diagnosed GBM trials start that time, to standardize them to where this study's baseline begins. It's interesting too that they pick that time point. Why? Well if DCVax-L is approved, therapies that used a placebo control would then to test along with the new standard of care (DCVax-L).
They also note what I've been saying about T2/Flair spotting progression sooner than MacDonald criteria. In this trial, it likely is helping the opt-in crossover patients get their vaccine sooner, and avoid a time to treatment delay that the prior Phase I/II ran into.
And to think so many longs here have jumped on the skeptic bandwagon to think that a "sorry Charlie" approach at Month 2 scan was being done on transient size changes (I.e., Brad's). If that were true then the primary endpoint would have hit years ago as even placebo patients will exhibit pseudoprogression on the Month 2 scan (treatment first testing scan), on the account of residual but delayed affects of concurrent RT/TMZ. But I digress.
Live in NY. Happy everything. :)
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