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Message: Re: My general impressions
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Nov 16, 2019 03:36PM
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Nov 16, 2019 05:30PM

Carman2 - The reason for the US patients being left out of the trial was because it took so long for approval to do the trial there that it would have delyed the trial somewhat. The first trial patient was dosed in 2015 and FDA approval to start in the US didn't come until about January 2018. In March 2018, RVX stated that they were looking at the possibility of including US patients. In June 2018, they announced that they were fully enrolled. Somewhere around that time, DM said that the FDA had informed RVX that due to the variety of patients enrolled around the world the US population was amply represented and US patients would not be required. Maybe this is what they meant by looking at the US possibility in March, that maybe US patients wouldn't be required. Anyway, the trial was almost totally enrolled by the time they were allowed to include the US and DM said they would forego the US to not have a substantial time added to the trial.

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