Lets be honest, this company is run by scientists who have extremely poor management skills of any sort whatsoever! They should have put out an 8K WHEN they filed for the RAT designation. It's a material event! They didn't. So we have no idea that they ever filed other than some crummy blog post, that we have no idea even when that was posted! Poor and shabby management.
All I can say is my previous experience of the FDA requesting more information is not good as to the final result as they err on the side of caution.