Predictive Technology Group Inc (PRED)

[Brian903]

Moving forward, in our Predictive Therapeutics business, we intend to pursue the FDA’s 351 regulatory pathway as we advance new cellular therapeutic candidates into clinical trials. Securing FDA approval via this pathway requires a rigorous demonstration of a product’s efficacy and safety at a time when the agency has increased its focus on companies offering potentially unsafe human cell and tissue-based products as therapeutic agents. We are in a unique position with our HCT/P platform as the significant safety experience of over 100,000 allografts used in patients in the U.S. market provides the ability to accelerate and de-risk the clinical trial pathway for FDA approved indications. We will announce the specific indications for which we are pursuing FDA approval.