We will get a conditional eGFR at circa week 70 (maybe mid Nov...

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aaron_george

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13/11/23

17:29

Post #: 70874368
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Originally posted by vrs37: ↑

neuren dec21 Ann. and future dimeric march 2024 Ann. aren't equivalent.
neuren dec 21 was their final phase 3 result.
dimerix March 2024 1st interim analysis is a FUTILITY analysis on 35 week urine protein result in 72 patients in their fgfs trial, that's what their abstract for the American nephrology congress says (anybody can download it).
as with any futility analysis, If standard practice is followed in this trial then it's a binary outcome (pass/fail) come march...
either: trial doesn't meet a predefined futility level on the urine protein result in the 72 patients, trial could be stopped as it's "futile" to keep going. or
trial does pass that minimum level, then expect a report on how comfortably it passed, and what are chances of achieving urine protein endpoint at the study end. That's how a futility interim is normally run and communicated in my experience.

But as I understand it GFR isn't part of that first interim analysis according to their release, and that's the main endpoint of the trial after about 2 years.

different to neuren as I said at start.

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We will get a conditional eGFR at circa week 70 (maybe mid Nov 24 ?), is how I see it - snippet below from Dimerix Website. But if Part 2 is positive, we have the potential to submit for a fast-tracked regulatorypathway to approval given the Orphan Drug Designation for DMX-200 in both the US and Europe for FSGS.

DXB Price at posting: 15.5¢ Sentiment: Hold Disclosure: Held
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