According to Bob Shepard, media relations at UAB, two letters were delivered with instructions on how to proceed with the program. Shepard noted that there were two letters because UAB is conducting two studies, one for children and one for adults.
“Receipt of the letters from (the) FDA means that we can move forward with the remaining steps that must be completed,” Shepard said in an email. “The modifications requested by (the) FDA were minor.”
“We are elated that the FDA has given the study the green light and hope that Leni gets the relief that she needs from her seizures on CBD oil,” said Amy Young, mother of a child currently on the list to receive treatment from UAB.