Avecho Biotechnology (ASX:AVE) has submitted its TPM-enhanced Vitamin K injectable product to the Food and Drug Administration (US) through Athenex Pharmaceutical Division in a pre-Investigational New Drug (pre-IND) meeting request.
If the FDA response to the pre-IND submission is favorable, Avecho and Athenex will sign a license and development agreement to complete the product development work for the NDA submission to the US FDA and product commercialisation.
Avecho and Athenex are currently in discussions to select a TPM-enhanced product for possible commercialization in the US market.
Following the announcement, shares of Avecho Biotechnology (ASX:AVE) were unchanged at $0.013.