Sdraw on twitter
Posted: Mon Oct 08, 2018 10:05 pm
https://twitter.com/_sdrawkcabeman_
Always worth a careful read. I still think Scarlett's wording re MF in R/R is unclear re "primary end points" (at 24 weeks) which we know are symptoms and SVR, and "primary analysis" which I believe took place starting in June ("before the end of the second quarter"). Anyone who wants to re reread and comment on the "Janssen walks" statement would be welcome. What I am saying is that I don't think we should look for more PRs or any CRs even though the MOS data and symptom reduction data looks pretty amazing but I think we have to accept that the primary end points in both spleen and symptoms were not met even after years of study. The MOS extension is a wonderful and probably unexpected surprise and to get symptom reduction in 1/3 of end stage dying patients with no hope has to be worth something. For those who are thinking "cures" or PR/CR in this population, I think those hopes are unwarranted. Dr. T's study did look at many patients with earlier stage MF disease and Geron has withheld any data as to what actually happened to the PR/CR patients that got our early attention, not to mention the other 50 or so patients subsequently enrolled in Dr. T's study, (this study will likely be presented at ASH also) this was egregious in my opinion as some confirmation of the PR and CR data would have been important to shareholders and patients. Dr Scarlett made a point of clarifying the MDS naive population results and making clear that the early look may not reflect an adequate assessment of the ultimate outcome so holding on to hope here does appear warranted. I am also hoping we will see compassionate use approval in R/R MF and speculate that some off label use might follow while some form of MF PIII happens. bp
Always worth a careful read. I still think Scarlett's wording re MF in R/R is unclear re "primary end points" (at 24 weeks) which we know are symptoms and SVR, and "primary analysis" which I believe took place starting in June ("before the end of the second quarter"). Anyone who wants to re reread and comment on the "Janssen walks" statement would be welcome. What I am saying is that I don't think we should look for more PRs or any CRs even though the MOS data and symptom reduction data looks pretty amazing but I think we have to accept that the primary end points in both spleen and symptoms were not met even after years of study. The MOS extension is a wonderful and probably unexpected surprise and to get symptom reduction in 1/3 of end stage dying patients with no hope has to be worth something. For those who are thinking "cures" or PR/CR in this population, I think those hopes are unwarranted. Dr. T's study did look at many patients with earlier stage MF disease and Geron has withheld any data as to what actually happened to the PR/CR patients that got our early attention, not to mention the other 50 or so patients subsequently enrolled in Dr. T's study, (this study will likely be presented at ASH also) this was egregious in my opinion as some confirmation of the PR and CR data would have been important to shareholders and patients. Dr Scarlett made a point of clarifying the MDS naive population results and making clear that the early look may not reflect an adequate assessment of the ultimate outcome so holding on to hope here does appear warranted. I am also hoping we will see compassionate use approval in R/R MF and speculate that some off label use might follow while some form of MF PIII happens. bp