notasperfectasyou wrote:I was just referencing that one of the issues everyone got upset about was that the trial had a much better than historically normal placebo response. At least that what I remembered. Ken
Opexa's explanation for the observation that you're referring to was that the patients were randomized to the treatment and placebo groups independently of their lesion burden. As it turned out, since lesion burden wasn't taken into account, the patients in the placebo group had an overall lower lesion burden than the treatment group. This characteristic of the study groups and was just by chance. A larger study population may have allowed for a more equal distribution of patient types between the two study groups, i.e., equalized the lesion burden. With a smaller study, such as Opexa's Tovaxin trial, it may have been benefical to have taken lesion burden into account when assigning patients to either the treatment or placebo groups. This would have assured that both groups were starting out on equal ground and would have made for a better assessment of the treatment's potential effectiveness.