Cell Therapy News/Articles, page-16947

Interesting observation about the single arm trial - I picked that up too. In preparing such a comprehensive document, the FDA seems interested enough in the unmet need not just the treating of of acute and chronic GVHD but of preventing it. One may say that’s their job to provide guidance but it’s still positive that GVHD has come on their radar. I wonder if it’s partially motivated by the gap between actual performance and their expectation of Rux at the point of approval.

I contacted the company about the Type A meeting. It appears that they are prepared to provide more information and/or confirmation when they receive the minutes back from the FDA. They are supposed to get the minutes back within 3 weeks of 21 Sep. Hopefully, this better flow of information continues not just over the next few months when it will be most needed, ie. when the final potency work gets done to respond to the FDA’s request for further data.