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One month since Glafabra's FDA INTERACT meeting.
That July 16 conversation shapes the IND protocol we're building now: endpoint strategy, patient selection criteria, conditioning approach. None of that gets finalized overnight — it's weeks of translating regulatory feedback into a protocol document.
For those tracking the timeline: IND filing stays targeted for mid-2027. First patient enrolled targeted H1 2028. Nothing has slipped.
For anyone who's taken a regulatory meeting through to a locked protocol: how long did that translation actually take you, start to finish?
Follow the whole series: https://bit.ly/Glafabra-TTW
@Brian Christie @Neva West @Chris Hopkins @Tetsu Yung
Testing the Waters disclosure: We are considering a capital raise and are "Testing the Waters" under Regulation Crowdfunding. No money or other consideration is being solicited, and any that is sent in response will not be accepted. We cannot accept any offer to buy securities, and no part of the purchase price can be received until an offering statement is filed and only through the BioTech Funding Portal platform. Any indication of interest is non-binding and involves no obligation or commitment of any kind.
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