Skelly22,
10K states following
"On February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration to initiate clinical trials assessing the company’s HemaXellerate drug currently in development in patients with drug-refractory aplastic anemia."
Now read this:
FDA Receipt of the IND:
Upon receipt of the IND by FDA, an IND number will be assigned, and the application will be forwarded to the appropriate reviewing division. The reviewing division will send a letter to the Sponsor-Investigator providing notification of the IND number assigned, date of receipt of the original application, address where future submissions to the IND should be sent, and the name and telephone number of the FDA person to whom questions about the application should be directed. Studies shall not be initiated until 30 days after the date of receipt of the IND by FDA unless you receive earlier notification by FDA that studies may begin.
No one knows for sure exactly when FDA received the IND application. I hope I don't have to carry this discussion further.
