Timeline for approval
Posted: Mon Jun 22, 2020 5:09 am
CKTC and HI, thank you for posting. Very disappointing after the FDA articles re RWD that Geron could not have been a test case (but still might be in other future indications per your post). What are your thoughts re the most optimistic timeline for approval? Since Dr. Scarlett has guided that approval would be reasonable in early 2024 I am wondering if he is managing expectations (again). Since P III data will be available in MDS sooner than MF and since the MDS trial is expanding in a big way, do you see any chance for an unplanned analysis earlier than guided currently? Since data are analyzed in a "rolling" fashion, achievement of a statistically significant primary endpoint might be apparent before the planned analysis. Do you see this as possible? Best Regards, bp