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Message: Re: A few comments
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Jan 10, 2017 01:24PM
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Jan 11, 2017 11:33AM
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Jan 12, 2017 11:21AM
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Jan 12, 2017 11:29AM
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Jan 12, 2017 02:10PM

Bear – thank you for your comments and corrections

I agree with the timelines you have given for event completions. From experience from past trials, dissemination of final data seems to have been about 4 to 6 months after the last data was received. I didn’t want to set myself up for failure in the event that the data follows previous patterns.

Number of events for trial end – my understanding is that the trial was designed with 2400 patients to achieve 250 events and was set at this number to achieve a 30%RRR and if that 30%RRR was not achieved with 2400 patients then an additional 1200 patients would need to be added to get a minimum of 375 events with a minimum of 25%RRR. I do not understand the math behind powering a trial to get statistically significant preset results so I have to defer to statisticians and scientists and doctors like you.

What %RRR is required for success – again I don’t disagree with you on having a successful trial with less than 25%RRR however I believe the number of patients in a trial that delivered less than 25%RRR would have to be significantly more to have statistically significant numbers. I am taking a page from someone else’s book in making that comment. I would be more than happy to eat as much crow as you all can dish out to me to have a significant deal done that puts a lot of dollars in our pockets if a BP was willing to pay up for this company if that minimum 25%RRR was not achieved in this BETonMACE trial.

Lottery ticket turning to trash – I can only refer to past trial data results being disseminated to the public that did not meet expectations. Take ASSURE for example, stated goal was .6% plaque regression over 6 months of dosing, we achieved .4% (which matched the best drug in the world at that time in ¼ of the time) and we saw the value of our company drop like a stone. When the full data set was disseminated some months later nobody really cared even though we had what seemed to be the best drug in the world for reducing arterial plaque. We can also go back to when the SUSTAIN results were disseminated and that muckety muck from Merck said "I wouldn’t take that drug it increases the liver ALTS" for which we had the share price careen down to the basement. Each time preset expectation have not been met the value of this little company took it on the chin and shoulder and knee. Each time the company has come back and continued on its mission for which we are here today. Each time the company needed to be refinanced and we accepted a little more dilution and each dilution split the pie a few more ways. Each time it took a couple of years to get back on our feet and running. My comment was to prepare me for the worst while hoping for the best, a reality check if you will.

As I stated those were my thoughts and I don’t expect anyone else to adopt them as their own. I am quite willing to listen to any reasoned judgment to change my thoughts if I am flawed in my assessment.

On another note I think that between the information presented on the post hock analyses of previous trials and what was divulged in the patent application for the combination Crestor/RVX208 there is reason to think that the number of events in this specific group of people in the BETonMACE trial will be high than was initially planned for and that the reduction in MACE events will also be larger that was planned for. A higher number of events would push everything forward.

I think the patent application had the best info I have seen to date on RVX208 including a 1.43% plaque regression.

DYODD

tada

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Jan 12, 2017 02:36PM
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