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Message: Re: Interesting comment from DM
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Sep 30, 2019 11:58AM
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Sep 30, 2019 12:03PM
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Sep 30, 2019 12:04PM
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bfw
Sep 30, 2019 12:05PM
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Sep 30, 2019 12:15PM
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Sep 30, 2019 04:09PM

 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! 

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Sep 30, 2019 05:10PM
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Sep 30, 2019 05:38PM
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