Re: Resverlogix Reaches Agreement With FDA for Key Aspects of Apabetalone Registration Enabling Study
posted on
Jun 22, 2020 10:50AM
Paladin ... I have been pondering the same question, can BoM2 replicate the good things from BoM1?! If so, then this will be in the money in a very nice way.
Let's remember this is a drug that has and is being "studied" ... failures of the past can be positive if you learn and adapt, refine the targets/endpoints, thinking and methods, use the previous knowledge, for refining the MOA knowledge and study design applications ... let's hope!
On the positive side, we have a crap ton more knowledge now, in fact some "new" knowledge. I would hope that guidance and direction from the FDA is helpful in this regard, and possibly even input from a partnering-interested BP? ... and lastly, there is a lot of room from 50-60% benefit to fall a little and STILL be a drastic and valuable improvement over baseline SOP if the BoM1 data is valid.
I share your question, but feel good about it. It "seems" the FDA (BTD) feels good about it also.
glta