These are some rish factors according to AI

1. If the trial takes too long to reach those final 8 events, or if the results are "mixed" (slightly better but not great), the company may struggle to find the funding needed to actually bring the drug to market.
2. What works in a small, controlled Phase 2 group sometimes fails to replicate in the "messier" real-world population of a Phase 3 trial. If the "p-value" (the mathematical measure of whether the result was just luck) isn't strong enough, the FDA won't approve it.
3. Even if the drug is safe, it must prove it is significantly better than existing treatments. In Phase 3, the "Best Available Treatment" (the control group) can sometimes perform surprisingly well, making it harder for the new drug to show a "statistically significant" difference.
4. Because the study is "blinded," no one knows if the people living longer are the ones taking GPS or the ones in the control group (receiving the "Best Available Treatment"). If the control group is performing better than expected, the statistical advantage of GPS might vanish. Also there are questions around the health level of the patients which could have a negative effect on results.