Re: Inflammation!!!!!!!!...
in response to
by
posted on
Jan 22, 2020 11:21AM
fuzzy/slickers ... at tthe risk of being "repetitive" :) ... I have been thinking this for some time now. Likely "deals" on the table with variable valuations subject to clarity regarding regulatory positioning which is now (hopefully) in process awaiting disposition. We knowwwwwww RVX is highly unlikely to go forward "alone" with Eastern and Hepalink (or Ori?) as the sugar daddy's for another 3-5 years (imho).
Funding is a concern, more for bargaining though, rather than "survival" imho. But, competition is the antidote, and can help avoid and fend off the bargain basement offers that financial/time leverage detrimentally brings. Competition can push the price more toward market pottential, if there is indeed strong interest in RVX's (apabettalone's) true market potential.
Bolt-on (and P4) question? ... I realize, a bolt-on requires status quo for the study and protocols, and maintining current end points? And hopefully, tthose endpoints that were narrowly missed due to underpowering will be properly beefed up for significance ...
However, based on significant new data from the interim BoM results, can "additional" endpoints be ADDED based on post-hoc "breakthrough" level data to date, coupled with additional pre-specified goals for a bolt-on ... IOW using accumulated post-hoc data plus new double-blinded data for ADDITIONAL pre-specified endpoints such as CHF & hospitalization, and maybe with an eye toward focusing more as well witth the new classes of SOC drugs growing in the market like the Jardiance class of drugs, etc?
I realize this is probably out of the norm, just wondering if there "could" be some flexibility in a bolt-on, especially if apabetalone is in "consideration" but falls short of "break-through" fast tracking, whatever exactly that is ...
... or, maybe, a short "additive" P4 accruing patients and continuing BoM, ... plus a few new pertinent endpoints additionally?