https://www.cytel.com/blog/late-stage-clinical-development-strategy-trade-offs-and-decision-making-in-the-confirmatory-setting?utm_campaign=Cytel%20Blog%20Subscriptions&utm_medium=email&_hsmi=290919421&_hsenc=p2ANqtz--fsh89Kb18C9VTI0uTbJpbi2_8BBNT_7zceEZH8mJzvffHjMRO9XE7BH5ROaK6d1Q5Gvca7TQ673Ddpfy9kCfIMcu00g&utm_content=290919421&utm_source=hs_email

I hope RVX checks this website.. I've posted a link to Cytel blog that talks about tips to late-stage clinical development. This blog seems highly relevant as they talk about composite end point, hierarchy in the end points in composite (hello? hospitalization?), interim analysis (stopping for fuility and/or efficacy), etc...

I'm going to post few of my thoughts:

1) I don't think BOM was underpowered. Rather, it either got effect size wrong (hence, calculation for population was off) or there's a subgroup more likely to benefit from APB compared to other groups. (Please check 'population enrichment' strategy in the blog.)

2) 'Near miss' for BOM... Some physicians are not impressed with P<0.04 unless it's like P<0.0001 or sth near that. So 'near miss' thing in RVX context is only good as it is informative as to which subgroup to target and/or end point to focus on going forward.

3) I really do hope they have generated lots of data (very expensive..) from BOM because that is like the most informative info right now for the future trials. Esp. subgroup to focus.

4) APB may be extremely safe drug, but if it's not effective for any of the potential indications, it's useless as a medicine.. *SOB*

It seems that 'hope' is the only thing that keeps this forum alive. I feel like RVX company should have some Medical Affairs personnel with expertise in clincial trials even if they have other company run trials. People say you can get from consulting only as much as you know.. The company that runs clinical trials can't hold hands at every step of the way. RVX has to make decision in the end. With BOM data, I hope they can make more informed decision this time... (also, guidance from FDA)