[Author Disclosure: This content reflects the views of the author and is provided for informational purposes only. It does not constitute investment advice and is not a recommendation or endorsement by BioTech Funding Portal. Any investment decision should be based solely on the issuer’s official offering materials.]
Designing a trial for two regulators at once is harder than designing it for one — but it's cheaper than doing it twice.
Glafabra's U.S. Phase 1/2 protocol is being built from the outset to generate the specific biomarker package — alpha-Gal A enzyme activity, plasma lyso-Gb3, eGFR slope — that PMDA would require for a Japan submission. That's a deliberate choice made now, months before IND filing, not a retrofit later.
For anyone who's run a trial designed for multiple regulatory audiences: what's the one design choice you'd tell an earlier-stage team not to skip?
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.
Register for FREE to comment or continue reading this article. Already registered? Login here.
0