...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: Re: ... a couple things...

"as of Friday, May 11th RVX's BetonMace Phase 111 Trials celebrates 2 1/2 yrs. or 30 months of continuous dosing of those patients involved... what was the previous longest trial for rvx, six months... a very important milestone with data presumeably being released by yearend..."

That's great to hear Kelsee. RVX announced almost 2 months ago (March 19th) that they exceeded full enrollment (2400 patients). The rate of accumulation of patient years is likely at or just past its peak right now, which means the rate of new 3-point MACE events occurring is also at or just past its peak. Some patients have already finished in the trial (see below), so these rates should start to drop off soon if they haven't already.

I threw in the "likely" above because first patient dosing was announced Nov 11, 2015 but the first enrollment update wasn't until Sept 12, 2016 with 600 patients. That is a 10-month window of uncertainty. So some unknown number of patients (greater than 1, less than 600) have already completed their 104 week (2 year) dosing and 4-16 week follow up. Patients are dosed for up to 2 years per trial design so unless they adapt the current trial there aren't any patients that are expected to be dosed beyond 2 years as your post implied. 

Based on company announced enrollment figures:

600 patients will complete 2-year dosing by Sept 12, 2018

800 patients (including previous 600) will complete 2-year dosing by Dec 15, 2018. 

1200 patients (including previous 800) will complete 2-year dosing by Mar 17, 2019

If BETonMACE does hit 250 and reveal top-line by years end, then the above gives an idea of how many patients will have achieved 2 years of dosing.

My old projections are pretty much outdated now, which is fine because there were a lot of assumptions and unknowns that gave rise to a generous and a conservative estimate. Since we have not had the 188 event SSRA announcement yet, this allows me to discard the more generous projections (that didn't happen) and solidify the more conservative projections. If the 188 adjudicated event announcement comes by the end of May 2018, then I project late Sept 2018 to be the earliest time to hit 250, with Oct 2018 being the hot zone. 

All just my opinion. Projections are my own based on estimated events rates and patient years. Projections subject to change as more information is revealed or with potential trial adaptations. Do your own due diligence. 

BearDownAZ

6
BKC
May 09, 2018 05:48PM
1
May 09, 2018 05:55PM
Share
New Message
Please login to post a reply