VRG50635 – Lessons Learned in ALS

In a recent blog we took issue with a Nature article about ‘Lessons learned’ after a TIGIT inhibitor failed in late Phase 3 development.  We felt that the article provided few insights, mainly platitudes. This week we saw a different kind of post-mortem.  It was about VRG50635, a PIKfyve inhibitor Continue reading VRG50635 – Lessons Learned in ALS→

Draft FDA Guidance for COCCIDIOIDOMYCOSIS

David Larwood, CEO of VFS, summed it up at the Cocci FDA workshop in 2020: “When the market opportunity is limited, finding investment becomes the key issue”.  He mentioned other problems as well: “Very low patient numbers for disseminated disease, prolonged therapy, NI trial design, definition of clinical outcome”.[1] Clearly, Continue reading Draft FDA Guidance for COCCIDIOIDOMYCOSIS→