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AGORACOM NEWS FLASH

Dear Agoracom Family,

I want to thank all of you for your patience with us over the past 48 hours and apologize for what was admittedly a botched launch of our new site.

As you can see, we have reverted back to the previous version of the site while we address multiple forum functionality flaws that inexplicably made their way into the launch.

To this end:

1.We have identified 8 fundamental but easily fixable flaws that will be corrected in the coming week, so that you can continue to use the forums exactly as you've been accustomed to.

2.Additionally we will also be implementing a couple of design improvements to "tighten up" the look and feel of the forums.

Sincerely,

George et al

Message: BETonMACE USA vs. non-USA brainstorming

"First dosing Nov 15, 2015"

Actually, first dosing was Nov 11, 2015 as stated in the news release titled "RESVERLOGIX COMMENCES DOSING IN PHASE 3 CLINICAL TRIAL BETONMACE". Let's just call it Nov 2015.

"First patient surpassed one year mark Dec 5, 2016 (first DSMB reporting)"

As you partially correctly stated, the second DSMB report on Dec 5th, 2016 quoted Michael Sweeney as stating "The first patients in the trial have now surpassed the one year mark and apabetalone remains well-tolerated with a consistent safety profile." This isn't too surprising. If the first patient(s) started dosing Nov 2015 then by Dec 2016 they would have been expected to hit the one year mark.

On August 29, 2016 in this ESC 2016 news release, DM stated "The trial has already attained one quarter enrollment of the planned 2,400 patients and remains on track with internal projections." I had notes that the company also made a similar statement in mid-September, which might have been stated at one of the conferences presented at in mid-September but I'm not sure which one. In any case, one-quarter of 2400 is 600 patients and this statement occurred in the Aug/Sept 2016 time period. Let's just call it Sept 2016.

The MD&A posted December 13, 2016 stated "Enrollment is on target to exceed approximately 1,000 patients (of the anticipated 2,400) by the end of calendar 2017." However, at the December 2016 AGM Q&A (thanks Torpedoman!), DM stated that enrollment was lagging behind and was only ~1/3 of the way through. So one-third of 2400 is 800 patients and let's just call it Dec 2016. Just to emphasize, the total enrollment at this point is ~800 patients. So between Sept 2016 and Dec 2016 only about 200 additional patients were enrolled.

"So how can we now say that only 600-to 800 patients will have reached the 2-year mark on Sept and Dec 2018. Bear respectfully....It just doesn't add up."

At least 1 patient enrolled Nov 2015

~600 patients enrolled between Nov 2015 and Sept 2016. 10 month range. 2 years from Nov 2015 is Nov 2017 and 2 years from Sept 2016 is Sept 2018.

~200 patients enrolled between Sept 2016 and Dec 2016. 2 years from Sept 2016 is Sept 2018 and 2 years from Dec 2016 is Dec 2018. 

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