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Since the last update (Sep 7): co-founder Dr. Jeff Medin presented the FACTS data at IFFD 2026 in Tokyo (Oct 2), putting it in front of the Fabry specialist community; the team took part in BIO Japan in Yokohama (Oct 7-9) to meet manufacturing and Japan-based partners; and this channel has walked through the program's key diligence questions: the biomarker and kidney endpoints FDA recommended, the known risks, the treatment landscape, manufacturing, and the U.S. trial design.
Interpretation: GT-GLA-S03 remains on the plan set after FDA's INTERACT feedback: finalize CMC, request a Pre-IND meeting, and target an IND in mid-2027.
Uncertainty: INTERACT feedback is preliminary and non-binding, the Pre-IND meeting is still ahead, and timelines reflect current planning, not guarantees.
Questions about any of this? Post them below.
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