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sentiment_stocks

10/02/20 8:38 PM

#313674 RE: antihama #313670

I wondered as to the same thing...

Along that line of thinking, if DCVax-L beat the Optune OS by two months - I'd consider that to be 22 months from randomization (not surgery, remember the journal article for the entire group was 23.1 mOS but that was from surgery and included the 3 month screening period), and that could even be for just the treatment arm, IF, IF, IF, the data were not stat sig, the treatment still beats Optune's current best historical data to date (even if that data is pretty much, IMO, utterly worthless beyond its 2-year data). And the current SOC of radiation and TMZ, beat the previous SOC by 2 months.
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Barunuuk

10/08/20 12:13 PM

#315330 RE: antihama #313670

I cant find any recent reference, but I recall the original OS endpoint was 2 months increase as that has been the standard comparison for GBM. Termizolomide was approved on 2 month increase from SOC. ICT-107 missed the 2 month increase in its phase 2 trial. 2 months OS increase has become the standard for acceptance as an effective GBM treatment

They did update the SAP, and I dont know what the trial design was changed to, (or if it was changed) but I wouldnt doubt that the secondary endpoint OS, was moved to compare itself to SOC data with the FDA's new approval of comparing SOC data.