Hartland,
In response to your question about new material at these conferences:
EASD: Based on the abstract, looks to be new material on TMAO/FMO3 as they relate to the effects of RVX-208 on the complement system.
ESC talk: Abstract not available for Ewelina's "Modulation of the complement cascade in cardiovascular disease patients by a bromodomain and extraterminal (BET) protein inhibitor," so I don't know how much new material.
ESC symposium: Only talk titles available. More importantly than new material is the fact that Kausik Ray, Jorge Plutzky, John Kastelein and Stefano Del Prato will be giving the talks. These are big league clinicians/researchers who will be speaking on behalf of the promise of BET inhibitors for treating high cardiovascular risk patients with diabetes at a conference that attracts ~27, 000 healthcare professionals from over 140 countries.
In response to your question about FDA involvement in BETonMACE, I refer you to slide 21 of the Q2 2016 update that summarized thee FDA course of action for 2016.
Meeting 1: Type C meeting, to discuss toxicology issues and go forward carcinogenicity program.
• An immuntoxicity rat study was requested by the FDA prior to phase 3 advancement in the USA. The main study finalizes this week to be followed by a wash out period and report compilation. No issues flagged to date.
• The carcinogenicity program is required by all prior to registration. Meeting discussions will be to ensure that our planned protocol meets with FDA expectations.
Meeting 2: Type B meeting, pre IND for our new renal program
• Review of top line PK data. The PK data will be derived from a new clinical program being launched this week in New Zealand. First patient dosing will be news released upon completion.
Meeting 3: Type C meeting, to discuss adding BETonMACE centers in US
• Review any outstanding requests from the FDA
• At the time of this meeting safety data from over 1,000 patients in the BETonMACE trial will be available, additional dose response work, MOA and liver biology work will be complete.
Best regards,
BearDownAZ
