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Message: Re-visiting Tundup's all-time top-rated message

Tundup still holds the record for 19 recommendations on this message from June 2018 (tied with Growcet's message from May 2018). Tundup previously wrote:

"I recently had the opportunity to catch up with management. Apparently the blinded data is all pointing in the right direction. The rate of MACE events has been dropping steadily since the beginning of the trial, starting off at the expected 8% per 100 patient years but now down to 7.2% per 100 patient years."

Just to note, in the quoted text above, it should be 8 events per 100 patient years and 7.2 events per 100 patient years, not 8% per 100 and 7.2% per 100. In the previous EXAMINE trial in diabetics with recent ACS (w/i 90 days), event occurence was greatest in the first 6-9 months and then the risk tapered off during the remainder of follow up. Since all but a small handul of patients are now at 10 months or more in their follow up, this means that most BETonMACE patients are beyond this relatively high-risk window.  I wonder where the events per 100 patient years is at now. Very likely we are at or below 7 events per 100 patient years by now. 

"Management is absolutely committed to reaching 250 total events so there is a risk the trial goes on a bit longer if the event rate continues to fall. However, the longer it goes on potentially the more powerful the results will be. Regulator has told RVX it needs 3300 patient years vs currently at 2400 years. Should reach 3300 patient years by end of this year (getting 7 patient years every day now, so +210 years every month)."

I don't think we've heard an official or unofficial update on the patient years since Tundup's info above. But based on above, we should be somewhere in the 3300 to 3800 patient year range now. Since we haven't heard word of hitting 250 events, I will assume it hasn't happened yet. So if the event rate is still 7.2 per 100 patient years, then the current event range could be between 238 and 273 for the 3300 and 3800 patient year values, respectively. But if the event rate has dropped to, let's say, 7 per 100 patient years, then this range drops to 231 to 266. Seems like BETonMACE should be right on the edge of 250 any day now based on this as well as managements guidance at the AGM. 

"Should be able to give top line results even if don’t reach 250 events (but will continue with trial until do reach 250 events). (Not sure I fully understood how you can give top line results before reaching the target number of events….)."

This statement previously confused me. However, in light of the AGM (point 2 on slide 17) as well as thinking things through in my post last night, I think this meant there two ways to get to 250. One was to stop dosing before hitting 250 events, and during the subsequent adjudication and safety follow up period additional "off-treatment" events would occur....eventually getting to 250 but not all 250 would be "on-treatment" events. The second way to 250 is what management chose going forward. That is to wait for 250 "on-treatment" events before ending dosing. During the subsequent adjudication and safety follow up period (2-3 months?) an additional 20 or so "off-treatment" events would occur, bringing the final tally to 270+. However, as I pointed out last night, the primary outcome analysis is only based on the "on-treatment" events, as I understand it.

BearDownAZ

 

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