The Weinberg Group


Since 2017, The Weinberg Group, a ProPharma Group Company, has provided regulatory support for SUBA-Itraconazole, initially for the BCCNS indication and more recently, for the metastatic castration-resistant prostate cancer (mCRPC) indication with a pre-IND meeting at FDA in the second quarter of 2019, an EOP2 (End of Phase 2) Meeting in the fourth quarter of 2019 followed by an IND application and clearance for INHIBITOR’s Phase 2b trial in patients with late-stage prostate cancer in December 2019. Based upon future funding, INHIBITOR will undertake an accelerated effort to launch testing of SUBA-Itraconazole in conjunction with chemotherapy in patients with late-stage prostate cancer.

For the past 36 years, The Weinberg Group has assisted its drug and device clients in achieving FDA approvals by combining decades of regulatory experience with deep and broad scientific knowledge. This combination enables The Weinberg Group to optimize the path to approval, diminishing cost, shortening timelines, and increasing the likelihood of success.