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Well, statistically speaking there should have been at-least...

  1. 2 Posts.
    Well, statistically speaking there should have been at-least equal number of vaccine vs placebo subjects with a total size of more than 80 but, it does not matter as this study was never meant to find the true statistical difference.

    As said in the Webinar, The study was for safety and efficacy (i.e. immune response).
    Even if it's statistically significant, the 'power of the study' would be very low.
    Power of the study means the ability to find a true difference when there is actually a difference.

    This is when the phase 3 trial comes in play to find the true difference with big sample size and significant 'power of study'. (Bigger the sample size, better the power.)

    IMHO, the results of this study are good enough to go ahead and plan the IIb trial.

    The HSV space has  great unmet need and there is no cure. I totally understand the HSV vaccine is not gonna cure the disease but it would be a functional cure where by the breakouts are reduced and there is no need for taking daily pills for suppression.
    No matter whats the ultimate phase III results this vaccine is going to have its place in the treatment and may be in prevention of HSV , also in reducing the transmissions.

    Financially, yes the funding should be from collaboration or private players or something else. I am sure the management will figure this out.
    Prof Frazer has great track record and in near future this vaccine and / or Genocea is going to be the nearest possible option for cure of genital herpes.
 
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