Final preparations are underway to launch the formal pre-clinical studies requested by the FDA as part of the Investigational New Drug (IND) application. Including these pre-clinical studies, the IND application process will require approximately a year to complete. This is the critical step needed in order to gain approval for clinical trials.
August 2013 Update from Dr. Henry Klassen
Dr. Klassen has authored an invited editorial in the August issue of the journal Clinical Investigation. The editorial provides an overview of current and upcoming trials with stem cells for retinal disease.
Save the date: Dr. Klassen will be speaking at a public FFB event in Pomona on September 7. Check with the local chapter for details.