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Message: Re: Resverlogix Reaches Agreement With FDA for Key Aspects of Apabetalone Registration Enabling Study

barsax - Firstly I am not a scientist and am not qualified to argue anything science related.

SGLT's didn't do us in during the BoM trial because of how they worked with ABL. It made it very challenging for us because of how well they worked with the entire patient population, specifically the placebo group. 

BoM was designed from 2 previous trials that had taken place prior to SGLT's and DPP4's becoming SOC.

You are absolutely correct in pointing out that ABL had close to zero effect on stroke and I believe that was part of the argument the company had with the FDA in the original design which fell on deaf ears.

I agree with you 100% that we owe a large measure of our success to the inclusion of SGLT2's and DPP4's. It seemed to be the excellent effect on the placebo group that was not calculated for appropriately in the trial design.

As I'm now in way over my head I'll leave this alone now.

tada

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