Timeline for approval

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Joined: Fri Jul 20, 2018 5:13 pm

Timeline for approval

Post by biopearl123 » 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

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Re: Timeline for approval

Post by CKTC » Tue Jun 23, 2020 1:51 pm

The Phase 3 MDS trial will need to run its course. There’s nothing Geron can do to speed access to the data other than speeding up patient enrollment. But there’s a lot the company can do to speed up the approval timeline as Fast Track status allows for “Rolling” submissions and “Priority” review. It’s time for all these highly paid people to execute.

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