BioStem Technologies Highlights Alignment with FDA’s Openness to Bayesian Statistical Approaches in Clinical Research
BIOSTEM TECHNOLOGIES NEW (BSEM)
NASDAQ:AMEX Investor Relations:
otcmarkets.com/stock/bsem/news/biostem-technologies-inc--announces-a-pre-clinical-study-of-bsem17-115-at-university-of-miami?id=177750&b=y
Company Research
Source: GlobeNewswire
POMPANO BEACH, Fla., Feb. 03, 2026 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of perinatal tissue derived products for advanced wound care, today underscored the significance of recent remarks from U.S. Food and Drug Administration (FDA) leadership signaling openness to expanded use of Bayesian statistical methodologies in clinical trial design and analysis. FDA Commissioner, Dr. Martin Makary recently described the agency’s evolving stance on Bayesian approaches as a “leap forward” for clinical science, noting their potential to improve trial design, dose optimization, pediatric extrapolation, and integration of early-phase data into later-stage studies — a shift aligned with emerging regulatory guidance on Bayesian methods from the agency. “This is an important and very positive signal from FDA leadership validating the advanced statistical analysis model used in our recen
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