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Message: Re: ... this from our girl in IR...

We have learned that: 1) Resverlogix is still blinded in BETonMACE; 2) the results of the SSRA, if and when it occurs, will be press released; and 3) patients are continuing on treatment until end of trial instead of the previously stated 104 week limit. We learn nothing new from the most recent BIO International slide deck, unfortunately, which is now posted.

Really the only unknown is whether the company still plans to do an SSRA. I agree that this is a valid question that as of yet hasn't received a clear answer. I posed my question as a way to ascertain whether the SSRA had already happened. Based on Sarah's response, it has not happened yet....otherwise they would have news released the results.

As of the March 19, 2018 news release relating to BETonMACE full enrollment as well as the MD&A posted to SEDAR on March 16th, 2018, the plan was still to conduct the SSRA when 75% of the planned 250 events (188 events) had occured. The next quarterly financials/MD&A update should be posted later this month. So we will have to look closely to see if the language regarding the SSRA has changed, assuming that we do not get an answer or DSMB/SSRA results beforehand.

SanFran speculated that: 1) "the [SSRA] analysis was moot as it was plainly clear that they were achieving significance. Why take the time and cost to do that if they already know the answer?" and 2) "the trial has already achieved the primary endpoint....  after all, they are keeping participants on drug past 2 years."

In response to #1 above and taking into account Sarah's recent responses, a) if the SSRA had already occurred we would have heard about it; and b) Resverlogix wouldn't know that they were achieving significance since they are still blinded. 

In response to #2 above and taking into account Sarah's recent responses, a) Resverlogix wouldn't know that they had already achieved the primary endpoint (Time to first occurrence of adjudication-confirmed narrowly defined MACE) since they are still blinded; and b) BETonMACE is an event driven trial, so if the 250 event target had happened, then the trial would stop.

BDAZ

 

 

 

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