Acceleration of FDA-Required GLP Gene Toxicity Studies with the GSM BPN-15606
As a result of an Ames positive result in a single salmonella strain (T98), the FDA is requiring that, prior to our pre-IND meeting with them, we perform a GLP Ames assay with a form of BPN-15606 (besylate salt form) that is equivalent to what will be used in our ...
April 26, 2016