Provention Bio (NASDAQ:PRVB) stock could be in action today as the company receives a favorable vote for Teplizumab from FDA Advisory Committee.
Co announced the FDA voted 10 yes and 7 no on the question, “Does the information provided in the background documents and presentations by the Applicant and FDA show that the benefits of teplizumab outweigh the risks in support of approval to delay clinical type 1 diabetes mellitus?”
The EMDAC based its recommendation on safety and efficacy data from the pivotal TN-10 Study in which a single 14-day course of teplizumab delayed insulin-dependent, clinical-stage disease by a median of at least two years in presymptomatic patients with Stage 2 type 1 diabetes (T1D) compared to placebo. Acknowledging the significant unmet medical need facing early-stage T1D patients, the Committee Members discussed the strengths and limitations of the clinical data and provided opinions on the proposed indication statement and potential post-marketing studies.
Biotech, Tech, and Crypto reporter
Anthony Gonzales brings 3 years of experience in helping grassroots, mid-sized organizations and large institutions strengthen their management and resource generating capacities and effectively plan for the future. He is also a mentor and professional advisor to artists working in all disciplines. He is the gold medalist from St. Marco University of Science and Technology in the Bachelors of Financial Management as well.