Toxicology testing is ongoing, and Pre-IND discussions with FDA experts in the Division of Cellular and Gene Therapies within CBER have helped to clarify the additional pre-clinical requirements to facilitate filing of an Investigational New Drug (IND) application. And these requirements are????
When additional supporting studies using SIMPLIVIR based on synDNA™ are complete, we will file an IND to allow for clinical evaluation of the product. Which supporting studies do they speak of? The last study I found relating to SIMPLIVIR report was released on Mar 2nd 2005... over a year ago.
I think as owners of the company we're due for an update.
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