The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst, page-952

A question for those more statistically minded.

Our phase 1 on 12 patients has a p 0.11 for the second cohort, meaning 89% certainty the results are because of the drug. In trials statistical significance starts at p 0.05 meaning 95% certainty.

My question is can any insight at all be gained from the p 0.11 and the Berry stats to give higher level of certainty that a phase 2 will be successful. I'm guessing probably not, but curious if anyone has stumbled on any studies that link the p value in a phase 1 to the p value in a subsequent phase 2.

My guess is, it gives some confidence, but there are way too many dependents on a sample size 15 to 20x bigger. The results could land absolutely anywhere.

Just musing how the p values translate across sample sizes etc, if at all.