Re: Interesting comment from DM
in response to
by
posted on
Sep 30, 2019 05:03PM
It’s all speculation and wishful thinking at this point, without full line data… But if the Crestor + Apabetalone group had significant results, and that part of the study was well powered with clinical significance, I would hope the company would lobby the FDA for application and consideration of that specific combination. Remember, if the data eventually shows that that was a winning combination and would have passed the trial on its own, essentially at that point the FDA is holding back a significant benefit to very sick patients based on their forced study design parameters which may have potentially clouded the overall trial.
Obviously we won’t know for a while what that data looks like, and I have no idea what the process would look like to push for that application? Or perhaps there is even opportunity built within the study and FDA processes for such a movement, in unique circumstances, whereby patient lives and finances Are greatly impacted?
And let’s not forget the other countries, with their own governing bodies. It’s a shame people have to leave the United States to get a life-saving treatment sometimes, due to overbearing FDA criteria/regulations.
Of course, I am being VERY presumptive here, without FLD, but it is certainly on my mind today!