Emergency Use Authorization Process
Our mutual goal is to expedite the Emergency Use Authorization process (EUA) and Investigational New Drug (IND) for the ReGen Factor bFGF Covid Reset drug to fight the after effects of Covid 19.
To achieve this goal we are working with our appointed FDA consultants and the FDA to compile the existing documentation required for the Pre-IND meeting and assist in the Clinical Trial Plan in preparation for the EUA/IND application. This meeting will provide further instruction and clear direction to proceed with either the EUA COVID-19 path or Peptide Skin and Scalp IND path. After this meeting there will be enough information to decide which application path will be most beneficial.