Re: Slides from Resverlogix Corporate Update 6/13/16
in response to
by
posted on
Jun 13, 2016 01:41PM
Lots of info in slide 21, also noted by Stock2740 in an earlier post. The renal trial seems to be tentatively named BETonRENAL, launching this week in New Zealand, with topline data in 2016 and a full blown dialysis trial in 2017. I'm assuming that this is with RVX-208/apabetalone as well, though not explicitly stated. Also, Taiwan BETonMACE involvement launching by end of 2016 and US involvment still possible (see below). Here is the text from Slide 21:
FDA course of action for 2016
To address any outstanding and go forward issues with the FDA we are planning for three separate meetings around years end;
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.