Highlights from Resverlogix Rodman and Renshaw 9/10 A few highlights I noted from the presentation.
They've finished drug production and have all facilities lined up for BETonMACE. They are a few short weeks away from starting enrollment. He also said towards the end that BETonMACE is about to launch, so looks like it will be early fall after all. Don did not allude to any "shortened" timeline due to reaching the 250 MACE events sooner, but instead re-iterated that it will be 2 year trial with about 2.5 years until results. First patient will remain on drug for 2 years and last patient for 1 year, so average dosing is 18 months. 13 countries lined up for BETonMACE. Most in Europe but also Israel, Austrailia, Argentina, Taiwan, Mexico.
MACE for BETonMACE will be restricted to severe 3-point MACE events (death, ischemic stroke, non-fatal myocardial infarction), whereas for ASSURE/SUSTAIN is was a mid-level 5-point MACE. I think this 5-point MACE also included coronary revascularization and hospitalization for unstable angina or heart failure based on info from previous presentations. By restricting to severe MACE, this prevents us from using the MACE event rate from ASSURE/SUSTAIN as a way to predict how long it will take to reach 250 events since BETonMACE will be restricted to severe MACE.
A couple of "very impressive publications" slated for early 2016
Announcing orphan indication in next couple of weeks. Future orphan indications will use follow on molecules, so not RVX-208.
There will be a Resverlogix Yale Club presentation to a group of analysts in New York on 9/25. This is in addition to the Global Chinese Financial Forum (GCFF) presentation in Toronto on 9/26. This will be a couple of big presenatations right before the AGM on 9/30.
As for the Nasdaq, he believes, has potential, hopefully, etc, within 6 months. Not a very concrete statement with all of those qualifiers.
Overall, a very nice webcast!
Best regards,
BearDownAZ