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Per FDA's INTERACT feedback, remaining work includes finalizing potency assays and release specifications, running a GMP manufacturing campaign under a closed process, completing additional nonclinical characterization FDA requested, and holding a Pre-IND meeting.
None of this is unusual for a pre-IND cell and gene therapy program -- this is the standard pathway, informed directly by regulator feedback rather than guesswork.
Timelines for CDMO partnership, GMP campaign completion, and the Pre-IND meeting are not yet finalized; the mid-2027 IND target reflects current planning, not a guarantee.
Follow along here as each of these milestones is reached.
Follow the whole series: https://bit.ly/Glafabra-TTW
@Brian Christie @Neva West @Brian Christie @Tetsu Yung
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