Iterum (ITRM, $0.63) denied approval by FDA for UTI Treatment

Iterum Therapeutics plc  said that it will not get approval for the current form of its new drug application for oral sulopenem.

According to the Food and Drug Administration (FDA), additional data are required and the company should conduct at least one more well-controlled clinical trial for its treatment of adult women with uncomplicated urinary tract infections. FDA mentioned that it is willing to work with Iterum on the design of clinical trials in order to address the issues the FDA identified.

However, Iterum CEO Corey Fishman  said the company is “disappointed in this outcome and believe that the data package submitted was adequate for the approval of oral sulopenem,” . Fishman added that they will still assess the points raised in the CRL for discussion with the FDA to determine an “expeditious path forward."

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Sergey Savastiouk|Expert

Sergey Savastiouk, Ph.D. has a degree in Applied Mathematics from Moscow University and has extensive experience as an entrepreneur, investor, manager, and mathematician. His professional expertise is in applied mathematics, mathematical modeling, system and pattern analysis, and software and hardware system integration. He has served as the CEO of several hi-tech start-up companies and nonprofit organizations, which has given him proven capabilities in business strategy for high-tech start-up companies, market assessment, company formation, team building, product development, marketing, and sales. He has published numerous articles in journals and magazines on related fields. As a retail investor, he spent 15 years developing his proprietary trading and quantitative algorithms (now Tickeron’s A.I.), which brought him significant returns in trading the stock market. His current work and goal in founding Tickeron is to bring professional, sophisticated stock market analysis capabilities to retail investors via an easy-to-use interface.