Re: Agm
in response to
by
posted on
Dec 13, 2017 11:29PM
Bear - I appreciate your technical expertise and comprehsive posts. I am only responding to your post because you said - Am I missing something. I don't think you miss anything, I am just letting you know what I heard at the AGM, and understand that you may have already heard what I will say.
Don said there were currently 2100 enrolled; however, the enrollment had been slowed down to allow for the US participation. He said that the maximum number per site was 3% or 72 patients. I believe he said one (maybe more?) sites had already reached 72 and one (maybe more?) were around 68. He said they would stop the enrollment at the slower sites, but he did not say that they would stop the enrollment at the faster sites. My take is that the FDA may have asked for 10 or 15% of the 2400, but Don did not say.
Don said that the trail can not be stopped at the FA or statistical analysis, now 188, as they have to go to the end of the study to verify the safety. He did not say what the end of the study was, but I take it as 250 events, but that is not to say the FDA might want some extension of the US portion.
Someone asked if there was a difference between the FDA and the EDA and the Chinese approvals. Don indicated that the EDA followed its own protocol for decision making and that the Chinese followed the EDA. I believe Don indicated that the EDA could approve prior to the FDA.
Don was quite excited about the 49/51 split between atorvastatin and rosuvastatin and that RVX had already followed this protocol and it turned out that this was one of the 3 minor study requirements that the FDA insisted on. He stated that this split was essential to the study. Now my interpretation of his excitement is that there are essentially now 4 study arms, the 2 original study arms are split again along the atorvastatin and rosuvastatin. I believe we know (hope) from prior study that the only effiacious arm is Apabetalone + rosuvastatin. The other 3 arms are then somewhat like placebo, as the results are somewhat already anticipated. In my mind, that means that 3/4 of the patients are likely to have earlier 3-pt MACE events than the Apabetalone + rosuvastatin arm. This could mean that the 3-pt MACE events happen more rapidly than we first expected as only say 1/4 are getting our preferred formulation.
Trust the above helps.
JMHO
Absolutely