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Message: Re: DSMB
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Feb 21, 2019 06:08PM
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Feb 22, 2019 04:50AM
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Feb 22, 2019 09:32AM

Feb 22, 2019 10:04AM

Narmac,

You may want to look at slide 17 of the BIO CEO presentation earlier this month and the AHA poster from November. In both cases, it conveys the both placebo and apabetalone groups are continuing dosing on their respective treatment past the originally stated dosing period. There's a little bit of ambiguity about the tail end: "up to 3 years" or "6-38 months". I asked IR for a clarification on this recently and they responded "There is no hard stop at 3 years of dosing as the trial is events based." However, it clearly shows that both groups are continuing and does not convey that placebo are being switched to apabetalone. 

I think you have a misconception that only those patients on apabetalone could continue dosing past 104 weeks. I don't recall any company statements that specifically indicated only the apabetalone treatment group to continue with extended dosing. I think you also have an additional misconception that placebo patients could be switched to apabetalone. You stated "I assume it might be a moral issue having those patients outside the medicated group to be kept inert from the drug." I think the only way a switch from placebo to apabetalone could occur is if the trial was halted early because of efficacy, and that subsequently patients regardless of placebo or apabetalone were invited to continue on apabetalone in an open-label extension type of trial. These would obviously would be MAJOR events that would require disclosure. Plus, this halt for efficacy would likely only occur with an official interim analysis. However, as we all know Resverlogix decided to skip the futility analysis and sample size re-estimation analysis. Furthermore, to make the placebo to apabetalone treatment changes you suggested in the middle of an incomplete trial would likely compromise the entire placebo controlled blinded cardiovascular outcomes trial.

Whether you continue to post on Agoracom or not is your own prerogative. I've previously said I was done posting on Stockhouse but I hypocritally still post on both forums. I do have one piece of advice for you though. If you post a question in the early morning hours on Agoracom and don't hear back an answer yet a few hours later and it is still pre-market, don't go complaining over on Stockhouse "Agoracom cant like this question cuz no response from anyone over there." Give it some time! Aren't you the one to remind us all to just chill when appropriate?

BearDownAZ 

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Feb 22, 2019 03:35PM
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