New FDA Guidelines - Allowing RWD in NDA

[lacour_98]

Any positive impact to Geron with FDA announcement today allowing RWD to be included in NDA submittals?

[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.

[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.

[biopearl123]

I agree. Most of us would not survive another two years if the results do not impress. Our OS would be exceeded.