Precigen: Phase 1/2 Study of AdenoVerse Immunotherapy Will Be Pivotal Study to Support Accelerated Approval

 FDA confirmed that the ongoing Phase 1/2 single arm study will serve as pivotal and no additional randomized, placebo-controlled trial will be required to support submission of a BLA –

–   FDA agreed on the required efficacy and safety endpoints that will support filing an accelerated approval BLA for licensure –

–   Enrollment and dosing in the ongoing Phase 2 portion of the study is completed –

–   If approved, PRGN-2012 would potentially be the first therapeutic for the treatment of RRP, a serious and difficult-to-treat orphan indication for which the current standard-of-care is repeated surgeries   –

https://finance.yahoo.com/news/precigen-announces-fda-confirmation-ongoing-110500434.html