Re: I think one major reason that,
in response to
by
posted on
Nov 01, 2019 04:07PM
It's my understanding that if the trial design was left all up to RVX that they would have only included Crestor and not Lipitor because that's what their phase 2 data clearly showed.
However the FDA insisted that it also include a Lipator sub group too presumably for the learning and the science more than anything else. I don't really know.
While I suppose RVX could have said no, that likely wouldn't have been a prudent move with establishing a relationship with the FDA I'm merely guessing.
The problem with having the subgroups divided into two (technically four with placebo) is that neither on it's own merit provides for enough statistical powering of the trial when all is said and done. Both RVX and the FDA would have known this fact prior to trial start.
So perhaps if the data is consistent and the FDA has a heart (no pun intended) they may consider a fast path long shot based on the Crestor subgroup alone assuming the Phase 2 and 3 data aligns. Secondary endpoints then become even more of an interesting wild card in this NDA decision.
And lastly to address the point of RVX wanting to include Lipator to gain total market share, I simply don't agree. Based on Phase 2 result there is no way RVX would have wanted the Lipator subgroup included in the study because phase 2 result suggest it really doesn't work nearly as well. And so it follows that if Crestor does work as expected, then ensuing market share will still actually follow and take care of itself in the long run.
just my opinions,
10BagR