Take aways from today's cc
Posted: Tue Mar 20, 2018 12:21 am
In the interest of parsimony I will summarize my thoughts in as few words as possible. Several board members in other forums have requested that I do so butI I think most of what I say has been discussed among many excellent posters. Fish has asked that I assume a co moderator position on his very excellent board which I am happy to do. I encourage folks to take advantage of his catalogue of pertinent studies and excellent discussions. I would ask for three things: civility, brevity and pertinence. So to todays cc:
For MF: 1. The obvious: OS is outstanding in R/R and median survival has not been reached but SVR etc. not like front line studies with Jakafi. 2. There are still patients in the low dose group. 3. Primary analysis begins Q2 (that's pretty soon) 4. The continuation decision occurs before the end of Q3 (that's pretty soon too). 5. Multiple indications suggest there will be a positive continuation decision (my opinion only) which triggers 65M milestone, they will also have internal data re MDS by then. 6. The CT site will probably be up dated soon so we can see the wording of the addendum that allows continuation of the R/R study well beyond the original stop date (my opinion). 7. No new clinical data until ASH--patience. 8. The continuation decision could conceivably come sooner than ASH (end of third quarter), this is material so I don't know how they can wait until after ASH. 9. Waffled on phase III study (my and other posters interpretation as you know has been there will not be one.)
For MDS: 1. Excellent data as all know especially in sub group which especially pertains to European patients who it was implied will be targeted for front line therapy. 2. No data until ASH, additional 20 patients enrolled quickly which almost certainly allows for ASH presentation and start of randomized study. 3. If you haven't listened to Dr. Raza you are not doing your homework.
No mention of AML or combination studies. Likely for competitive reasons. We know the basic science data is very strong and there may be multiple indications hinted by recent patent filing. Please feel free to add to list or add criticisms. The past week has been very strong for Geron. Best wishes to all, bp
For MF: 1. The obvious: OS is outstanding in R/R and median survival has not been reached but SVR etc. not like front line studies with Jakafi. 2. There are still patients in the low dose group. 3. Primary analysis begins Q2 (that's pretty soon) 4. The continuation decision occurs before the end of Q3 (that's pretty soon too). 5. Multiple indications suggest there will be a positive continuation decision (my opinion only) which triggers 65M milestone, they will also have internal data re MDS by then. 6. The CT site will probably be up dated soon so we can see the wording of the addendum that allows continuation of the R/R study well beyond the original stop date (my opinion). 7. No new clinical data until ASH--patience. 8. The continuation decision could conceivably come sooner than ASH (end of third quarter), this is material so I don't know how they can wait until after ASH. 9. Waffled on phase III study (my and other posters interpretation as you know has been there will not be one.)
For MDS: 1. Excellent data as all know especially in sub group which especially pertains to European patients who it was implied will be targeted for front line therapy. 2. No data until ASH, additional 20 patients enrolled quickly which almost certainly allows for ASH presentation and start of randomized study. 3. If you haven't listened to Dr. Raza you are not doing your homework.
No mention of AML or combination studies. Likely for competitive reasons. We know the basic science data is very strong and there may be multiple indications hinted by recent patent filing. Please feel free to add to list or add criticisms. The past week has been very strong for Geron. Best wishes to all, bp