The willfull blindness of the FDA, or Death by FDA

[biopearl123]

Here’s a summary of the FDA stand on approval of Imetelstat (12 for, 2 against). The FDA used IWG criterion from 2006 (committee started meeting in 2004) more than 20 years ago. The dramatic improvement in HI-E was completely obscured by these ancient criterion. The FDA said “sorry, predetermined criterion” and the dissenters wanted yet “more time and more studies”. No wonder patients die waiting for drugs. Here’s the recent paper summarizing the proceedings (no real discussion about the impact of now using updated information. But they did require more studies! (A P IV is outlined in clinical trials site—more time, more money):

https://pmc.ncbi.nlm.nih.gov/articles/PMC12614338/

I only bring this up, worrying about how high a bar the FDA will require when evaluating the IMpact study. Will we need to endure 2 1/2 years of “more time and more study”? Will the interim analysis suffice? Will they use a buggy whip in the time of AI?

[Zhears]

Considering the previous behaviour of the FDA and current changes in staffing at the FDA and tariffs, etc, geron really needs to embrace ex-US.
I don't mean just for sales either. Trials in countries where the cards aren't stacked against them, or take 5+ years to be worked through. If the results we imagine will happen if the drug is used in 1st line therapy, then the evidence will be undeniable.
The US administration wants drug development to happen in other countries, then it should be embraced.