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Hoskuld

07/20/23 11:15 AM

#423606 RE: 12x #423603

I don't really think your points are valid. There is clearly no significant titration issue - no SAEs, and excellent across-the-board efficacy of 45% reduction in progression over placebo over 48 weeks.
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bas2020

07/20/23 11:15 AM

#423607 RE: 12x #423603

Not worrisome at all...

FDA wants to see definitive dose dependent efficacy


Dose-dependent responses can be seen at lower dosages. It doesn't have to be 50mg for some.
The genetic data will substantiate this fact for the FDA.
This is the "precision medicine" aspect...