- Kalytera Therapeutics (OTCQB:KALTF) will meet with the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (“FDA”) on Tuesday, July 31, to discuss numerous aspects of company’s planned registration study evaluating cannabidiol (“CBD”) for the treatment of acute graft versus host disease (“GVHD”).
- Kalytera’s President and CEO, Robert Farrell, commenting on the meeting said, “The meeting with CDER is an important next step in the advancement of our program in treatment of acute GVHD. We recently submitted questions to the FDA as part of our pre-IND submission package. With answers to these questions and any additional information provided by CDER during the meeting, we will be in position to address any open issues or requests of CDER before submitting our IND. Once the IND is submitted and found to be acceptable to the FDA, we will initiate our planned registration study in treatment of acute GVHD.”
- Press Release
- Now read: Impact On Current Shareholders Of Seadrill Exiting Ch.11
Original article