Protagenic Therapeutics, Inc. (Nasdaq: PTIX) a biopharmaceutical company focused on developing therapies to treat stress-related neurologic disorders, today announced that upon reviewing its investigational new drug (IND) application filed on June 29th, the U.S. Food and Drug Administration (FDA) has requested that Protagenic provide clinical sites with ready-to-inject clinical vials rather than providing site pharmacies with drug substance to be formulated locally. Implementing this FDA guidance will have the added benefit of Protagenic’s control of the formulation of the final drug product. Protagenic is immediately implementing this required change. As a result of this development, the company expects to refile its IND and commence patient enrollment in the 4th quarter of 2021.
https://finance.yahoo.com/news/protagenic-therapeutics-updates-timeline-commencement-202100878.html
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