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New FDA Guidelines - Allowing RWD in NDA
Posted: Mon Dec 15, 2025 5:35 pm
by lacour_98
Any positive impact to Geron with FDA announcement today allowing RWD to be included in NDA submittals?
Re: New FDA Guidelines - Allowing RWD in NDA
Posted: Mon Dec 15, 2025 8:11 pm
by biopearl123
lacour, this was the only thing I could find:
https://www.fda.gov/science-research/sc ... d-evidence
Doubt it would change anything for Geron as the current MF/OS study will trump everything if significantly positive.
Re: New FDA Guidelines - Allowing RWD in NDA
Posted: Mon Dec 15, 2025 11:59 pm
by lacour_98
Wishful thinking, but as much as Geron has touted IMET for MF against RWD on other BAT the last couple of years.......
However, should Interim results in mid-2026 not deliver a knock out punch, maybe RWD in a NDA could get Geron over the finish line. To me, another 2 years to complete P3 to enable a NDA would be almost unsurvivable.
Re: New FDA Guidelines - Allowing RWD in NDA
Posted: Tue Dec 16, 2025 1:25 am
by biopearl123
I agree. Most of us would not survive another two years if the results do not impress. Our OS would be exceeded.