[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.]
The clinical data package FDA asked for in INTERACT feedback (alpha-Gal A activity, plasma lyso-Gb3, eGFR slope) is largely the same package Japan's PMDA would want to see for a parallel review. Glafabra is building Japan pharma and academic relationships (via IFFD, BIO Japan, and direct outreach) in parallel with the U.S. trial, rather than sequencing Japan after U.S. approval.
Done well, this could compress the time between U.S. and Japan development rather than treating Japan as an afterthought.
No Japan partnership is finalized. This describes an intended structure and current relationship-building, not an agreement.
Follow our BIO Japan and IFFD coverage this fall for how this develops.
Follow the whole series: https://bit.ly/Glafabra-TTW
@Brian Christie @Neva West @Brian Christie @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