Oh Geez, it is totally about biomarker results & also the number of patients needed for statistical analysis at each Interim analysis (refer to trial design) for Endpoints. The story keeps changing, & make sure you factor in Rare disease & Orphan status into those numbers. Completely different for most regulatory approvals (dual PH3 trials & thousands of participants).
Enjoy your time travelling & take care. If you have the statistical analysis formula from a double blinded & quadruple masked trial from the ACTION3 trial, GL with that. There are others to compare to.
Ann: Application for quotation of securities - DXB, page-113
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