Fosco1, thanks for the recap of what our Gary posted. Yes, so far NWBio has conducted two Spring Refreshes of blinded data interim analysis one around March 2017, and the second around March 2018. They did not conduct 2019 or 2020 Spring Refreshes afterwards. All the blinded data to date they have reported was based on data collected up to the year 2018. There was a last set of recruitment of patients in the year 2015 and the last patient got his surgery done and vaccinated was in the year 2015. So, the surviving patient in this trial is alive at least for 5 yrs. In the 2018 SNO presentation, Dr. LL reported there are about 90 patients alive out of the 331 patients recruited (both placebo about 100 and Treatment 221). The attrition rate since 2018 is guessed to be around 0.5 to 2% event/death per month. We should have about 50 patients alive now at the minimum looks like.
Yes, the data keeps maturing from 2018 to present date and we should have probably improving OS data from 2019 into 2020 as more and more patients (those who were recruited in the later years) are not censored anymore in the KM analysis and survived above the previous median (more than 5 years). Yes, this will have as an effect to right offset the confidence interval. In fact, Les in his Russ&Sully shows in the last few weeks keep telling us the mOS for the top 100 patients went up to 60+ months now; so looks like the OS is improving as the data is maturing and looks like the attrition rate is negligible that who crossed 5yr survival probably reached CURE going strong.
Yes, for FDA approval, all we have to show is I think like 4 months improvement in the mOS. Another way of looking at it is to show 35% benefit better than the standard care like FDA Commish or Health Sec said a few weeks ago on the Covid plasma news podium. Whereas in our trial, we have about 15% of the trial patients survive thru 5yrs while only about 6% survive 5yrs in the standard care which is more than 200% improvement. Similarly we have several hundred percent improvement in each 2year, 3yr, 4yr overall survival data over that of standard care.
Yes, it is looking obvious that this treatment population is surviving longer several hundred percent more than the ones receiving standard care and that must be the effect of the drug.
We will find out everything hopefully by the end of September when TLD is revealed as promised by the Company. We should hear Data Lock news any day this week. Good Luck to all longs!
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