Great presentation. Don only spoke for a few minutes of the 1 hour, 43 minute, 96 slide presentation with Q&A session.
- 2 members of the BETonMACE clinical steering committee spoke: Chair Kausik Ray and committee member Kamyar Kalantar-Zadeh. They gave a comprehensive overview of the clinical relevance/unmet need for cardiovascular disease in diabetes and chronic kidney disease patients. Kamyar expanded a lot of the relevance of alkaline phosphatase changes.
- Michael Sweeney gave a great overview of BETonMACE trial design and also disclosed new insights into the transient elevations in ALT.
- Ken Lebioda gave a very optimisitc presentation on physician feedback/market analysis/market opportunities. He mentioned a KOL Market Research effort with 20 physians in the US and EU (cardiologists, nephrologists, endocrinologists).He also touched on pricing of the drug based on achieved RRR and physician feedback a variety of issues.
- Ewelina Kulikowski presented the microarray/gene expression/pathway analysis with emphasis on complement/coagulation cascades. She also disclosed that they have a collaboration with a group in Colorado to look at 1300 plasma proteins in their archived clinical samples to demonstrate dose response, identify additional biomarkers and validate preliminary observations. I think this will be in the ASSERT population. She also touched on the complement related orphan diseases. Sounds like orphan trial launch in 2016.
- Nice Q&A session too. Don mentioned there won't be any interim analysis/sneak peak other then the required interim safety analysis by the data safety monitoring committee. It was the trial regulators that wanted the 3-point MACE. No update on launch of trial other than "imminent." Still optimistic on Nasdaq, though no timeline provided
Best overall presentation I've ever seen from RVX. I really like that they released this publicly the day before the AGM.
Best,
BDAZ