RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:FDA IND NEWS!!!!!!!!!!!!!!!!!!
While it's probably based on FDA simply needing more information "to assess the risks to subjects" (Ground 4) since lasers are still somewhat sci-fi technology, I wouldn't be surprised if the clinical hold is based on Ground 5, questions around the potential for "risk of reproductive toxicity."
Not saying there is a risk, but maybe FDA had questions about the potential of laser light to affect women of child-bearing potential and possibly cause sterility? Or is our potential patient pool so much older that this concern is completely out of the question?