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Message: Re: BETonMACE Enrollment
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Mar 26, 2017 03:01PM

BDAZ - I had a go at your fuzzy math using your methodology however I did use the numbers presented at the Broker meeting to adjust. At that meeting it was reported that over 190 events had occurred to that point and clearly stated that it was all events and not just 3 point MACE events. There where +/- 1200 events to that point in the trial. Doing the math that equals a 15.8% event rate based on the numbers presented. That 15.8% event rate is 43.5% higher than the 11% you used in Group 1 so I used that for the bases of adjusting all of the rest of the numbers using your methodology for Group 2, 3 and 4. Based on this process we would be at 146 events on 17 Mar (just over a week ago). Importantly these are not just 3 point MACE events.

Based on my math using your methodology and allowing 90 days for the adjudication process we could hear the futility results in July or Aug which is in line with what was stated at that Broker meeting. http://agoracom.com/ir/Resverlogix/forums/discussion/topics/686620-broker-meeting-23-feb/messages/2140188#message 

Interestingly the news release 17 Mar says 1200 patients recruited and the PP Presentation put out 21 Mar says 1400 patients. That's a heck of big recruiting success in just 4 days. Based on 140 patients per month recruitment rate also stated in that meeting, recruiting would be completed in Nov 2017. I believe I saw a timeline presented in the past that suggested a completion around Sept 2018 which would suggest that the pace of recruitment would have to be stepped up which is why we are seeing Russian sites being opened soon. This completion date of recruiting also coincides with the completion date of the trial dosing which was expected to be Q3 2018 after the last patient recruited was dosed for a minimum of 1 year. I know you have been conservative in your process and was I likely a little in the other direction.

This is going to be an interesting couple of months. Since we didn't hear anything about the FDA requesting changes to the Renal Trial in the last couple of days the excitement level could get elevated as well.

Is the next news release going to be finance related or FDA approval of BETonMACE?...or something else.

 

tada

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