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Message: Re: We Need The Futility Analysis
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Feb 06, 2018 02:23PM
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Feb 06, 2018 05:13PM

Toinv - Nice overview, thank you. There is a significant amount of data that the company has about the 3 previous trials that you refer to that may or may not be in the public domain. All of that data which is hordes, can be broken down for them to determine 3 point mace events on dosed and placebo patients. BDAC has written or included links to this info over the years that gives people like you and I that don't  necessarily know where to look the opportunity to read this info ourselves. Thanks for that BDAZ. Having read most of the info from these links, sometimes a few times, I am beginning to understand more of what I am reading without being a science person.

From memory, in the ASSURE trial there were only 3 patients in this exact category, CVD, DM & low HDL that had 3 point events over the 26 week period out of the group of 17 patients total that met this criteria. I do not recall the breakdown of how many were dosed/placebo. In any event the difference between these two groups was so large that another trial was planned after the full data set was received. Again from memory I think this was the time the Eastern loan came into being.

The IR department of this company, in my mind, doesn't have a good ability to spin info into its best form. In the ASSURE trial they achieved .4% plaque regression which was less than the goal of the trial of .6% and consequently they failed the trial. At that time the best drug in the world for regressing plaque was Crestor, in very high doses for 2 years which netted .4% plaque regression. Although RVX failed the trials preststed goals, they matched the best drug in the world for regressing plaque in 1/4 of the time. They did it in a safe manor without having the patients go through the pain of a high dose statin for 2 years. Why wasn't the IR department crowing about this finding from the highest tree? There was virtually nothing said about the one patient that was a non-compiler that had 5.6% plaque growth that was suppose to be on RVX-208 that didn't have any drug in his blood at all. That one patient may have on his own, caused the company to fail the trial. This information seems to have been lost on the public.

It was interesting when the Top Line results from ASSURE came out that Dr Nicoles said that this obviously needs to be studied further. Which was very different than Dr Nissan's(wrong spelling) comments of the drug doesn't work which sent our share price careening into the basement. 

My point of bringing this up is that with all of the data that the RVX scientists have access to and to be able to compare that data to ALL of the blood draws that the company still maintains should give them enough information to determine whether the odds of a successful Phase III trial was in the cards. It was not the companies determination to forgo the FA at 125 events. That determination is in the hands of the DSMB. I have heard (yes hearsay) that DM was quite POed with this but just has to roll with the direction he is given. It is my thought that the IR department could do a much better job than what they have done in the past.

The SSA whenever that happens will tell me a lot. If the response comes back at "continue on the way you are" it is my opinion that a deal could happen at any moment. Anything other than something close to that wording from the DSMB may be viewed as negative and send our share price down. Given my previous sentence it would be prudent for any new investor to pay close attention to the words used by the DSMB before making a significant investment. Without this information I can totally understand why there is not a big increase in the share price at this time. We can't be to far away from that point now and frankly I'm vibrating with anticipation.

Toinv you are not the only rambler on this board.

tada

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Feb 07, 2018 01:09AM
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