FYI

Source - Prostate Cancer Today Oct 15 2019

Zejula Granted FDA’s Breakthrough Therapy Status for Treating Metastatic Castration-resistant Prostate Cancer

Oct 09, 2019 10:13 am | Ana Pena, PhD

The oral ovarian cancer treatment Zejula (niraparib) has been given Breakthrough Therapy status by the U.S. Food and Drug Administration (FDA) for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who carry BRCA mutations and have been previously treated with certain therapies, namely taxane chemotherapy and androgen-receptor targeted therapy. Breakthrough Therapy designation is expected to accelerate the development and regulatory review of an investigational treatment that's intended to treat a serious or life-threatening condition. The designation is given when preliminary evidence supports significant benefits of the new therapeutic candidate compared to available treatments. The FDA based its decision on a preliminary analysis of the ongoing GALAHAD study (NCT02854436), a Phase 2, open-label clinical trial running in multiple countries worldwide and sponsored by Janssen, a company owned by Johnson & Johnson

From recall I believe that the TNBC trial with zen3694 and Pfizer's drug excludes women with the BRCA mutations.

So it is possible to get accelerated FDA approvals in the cancer area. Perhaps there is hope for zen3694 with strong scientific results and Pfizer's clout. I hope so because the AGM agenda looks like same old same old with no liquidity being formally addressed. The underline above is mine.

GLTA

Toinv