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Message: Re: National Kidney Foundation -Abstract: BOM

GP, 

"4) Hint that maybe a new study is necessary for NDA in the NR this morning - Apabetalone development program moving toward next study to enable a New Drug Application filing"

I agreed with all four of your points when you posted them, but I've gone back and re-read the NR a few times after Golf pointed out interesting wording regarding a subsequent study enabling an NDA. Browsing over it again this morning, the following part really jumped out at me: "In previous clinical trials, apabetalone reduced the incidence of major adverse cardiac events (MACE) by up to 62% in various cardiovascular disease patient populations. Although treatment did not produce a statistically significant hazard reduction in the primary outcome measure, there was a strong trending hazard reduction – comparable with that of other cardiovascular outcome trials that led to approvals – and the authors of the publication and editorial suggest a larger trial with expanded endpoints may yield a different result." 

Running off memory here, but in one of the CC's or presentations tht DM did (possibly AGM), he stated something along the lines of pushing for approval, even though RVX may not be successful on their first attempt. You listed other important milestones that have happened since then (BTD, 2 in 10,000 chance of false positive NR on Jan 13th, etc) which have helped strengthen RVX's chances since DM made the statement of pushing for approval prior to another stage 3 trial.

I think that we will find out at that DM did do everything he could to push for an immediate NDA, but whether or not he turned out to be successful remains to be seen.

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