Sdraw
Posted: Fri Jun 08, 2018 10:11 pm
Few posters has the scientific background or the willingness to educate that Sdraw does. I wish he would post here but I am unable to approve new posters even though I function as a moderator of sorts so instead I will for now be more of a triage agent and post links. Here is a link to Sdraws tweets. He has given me permission to repost in the past and I will assume this carries forward unless he tells me otherwise:
https://twitter.com/_sdrawkcabeman_/sta ... 50624?s=21
I did go back and re listen to the Geron stockholders conference call. Sdraw address many of the same observations I had and have shared elsewhere. I think the important thing to remember in MF study is that at about 31 months of data collection (time from first enrollments) to March/April data cut median OS had not been reached and stood at 22 or so months. The patients are living so long that OS must be projected rather than realized in real time. There is no way this never before described effect on longevity can be ignored by regulatory bodies (EU and FDA). As I have said previously this will almost certainly lead to AA status. The MDS study is a little more curious to me. There has always been talk about the placebo controlled phase III but is just have a small sense that Scarlett protesteth too much and that as more data is collected, if the amazing TI rates are confirmed, we will see a modified protocol to speed things along. Remember we are seeing very new and very different and heretofore un described results in these hematologic malignancies. bp
https://twitter.com/_sdrawkcabeman_/sta ... 50624?s=21
I did go back and re listen to the Geron stockholders conference call. Sdraw address many of the same observations I had and have shared elsewhere. I think the important thing to remember in MF study is that at about 31 months of data collection (time from first enrollments) to March/April data cut median OS had not been reached and stood at 22 or so months. The patients are living so long that OS must be projected rather than realized in real time. There is no way this never before described effect on longevity can be ignored by regulatory bodies (EU and FDA). As I have said previously this will almost certainly lead to AA status. The MDS study is a little more curious to me. There has always been talk about the placebo controlled phase III but is just have a small sense that Scarlett protesteth too much and that as more data is collected, if the amazing TI rates are confirmed, we will see a modified protocol to speed things along. Remember we are seeing very new and very different and heretofore un described results in these hematologic malignancies. bp