RE: Activ-2 efficacy results16 Nov 2021 12:14
But we know that they wouldn’t be progressing this to a trial on 600 people unless it showed benefit in P2. That would be unethical, to use their language. A reminder from the trial protocol:
Graduation of an investigational agent from phase II to phase III evaluation will be based on there being a desired level of evidence of an effect of an investigational agent versus placebo on one or more virologic and clinical outcome measures, as well as safety, as described below. The level of evidence required for the virology and clinical measures for agents evaluated in phase II of this protocol will be expressed in terms of Bayesian probability statements of the following form:
Probability (agent is better than placebo by at least X) is greater than 0.6 where X is defined below for each outcome measure. The choice of 0.6 for this probability indicates that there is a 3 to 2 odds of the agent being better than placebo for that parameter.