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Biotech / Medical : Regeneron Pharmaceuticals
REGN 628.00-2.2%Nov 4 3:59 PM EST

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To: Miljenko Zuanic who wrote (3452)2/14/2022 8:01:30 PM
From: CuttingEdge Bio  Read Replies (1) of 3557
 
What they are planning to do is to show a non-inferiority result between the 12wk and 16 wk 8mg dose arms vs. the set 8-week dose Eylea 2mg arm, similar to what Roche showed for its bispecific.

In the case of Roche, their faricimab arm was PRN, so the result was some percentage of patients who were able to go out to 16 weeks, some % out to 12 weeks, and showing the overall cohort still matched the outcomes with non-inferiority to the set dosing for all regimen.
It is unclear to me whether Regeneron is doing PRN like that or simply having a set 12 wk arm and a set 16 wk arm on 8mg. If the latter, a win on that would be more impressive.

The primary endpoint is at whatever week (48) but they'll have to show the plot over time comparing the different dose arms to really judge it.
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