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Re: Tomdontworry post# 7664

Tuesday, 06/11/2024 4:17:50 PM

Tuesday, June 11, 2024 4:17:50 PM

Post# of 7716
Re: EU Daxxify opportunity /cell-based potency assay

Europe awaiting animal trials green light.

No! What Foley stated on the GS webcast is that animal testing is prohibited in certain European countries, and hence RVNC is employing a cell-based potency assay to obviate the need for animal testing.

RVNC’s cell-based potency assay is currently under evaluation by the FDA; once it is cleared by the FDA, RVNC can use this assay to support a Daxxify BLA in Europe.

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