Advaxis Completes Pre-IND Meeting with FDA for Prostate Cancer Treatment
The FDA addressed the company's questions and provided guidance on the requirements to file an IND to initiate clinical trials.
Biotechnology company Advaxis, Inc. completed a pre-IND (Investigational New Drug) meeting Wednesday with the FDA to discuss the development plan for ADXS-PSA, a construct for the treatment of prostate cancer. This IND is expected to be filed before the end of the year.
The FDA addressed the company's questions and provided guidance on the requirements to file an IND to initiate clinical trials.
A pre-IND meeting is conducted to develop mutual understanding and agreement between the FDA and the Company regarding the content needed to assess manufacturing, toxicology, pre-clinical and rationale to support a first in humans clinical trial. Based on FDA input, the planned toxicology studies will be completed on schedule for a filing by year end. Once an IND is filed
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