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Biotech Hangout @BiotechCH on x 14.6K followers
Created: 2025-07-18 16:40:51 UTC
Are there ways for the FDA and biotechs to work together and eliminate bureaucratic red tape that slows time to market? @adamfeuerstein points to the recent CRL for $RARE’s gene therapy for Sanfilippo syndrome, which was rejected over the number of thermometer probes in shipping containers. “I think this frustrates a lot of the industry. People have called for common sense ways to eliminate these types of roadblocks and hurdles to streamline drug controls…Now, this is a gene therapy that, instead of being approved in August, may not be approved until 2026. For patients that's a significant, meaningful amount of time.” #BiotechHangout
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