If it is clearly not the case? This is clearly an unmet need...

If it is clearly not the case?  This is clearly an unmet need where the FDA has said they would "exercise flexibility" and that "safety is not really what is keeping drugs from coming to the market."  Something isn't right here.

Around 1:24:45
https://collaboration.fda.gov/p5ovxjy4vd9/?launcher=false&fcsContent=true&pbMode=normal

“I think that this is a good time to assure you that safety is not really what is keeping drugs from coming to the market. Again, we really recognize the severity of the condition and we take that fully into consideration as we [inaudible] assess? the risks and benefits of the treatment. And for diseases like Huntington’s we really [inaudible] safety issues before considering not putting the drug on the market. Again we want to exercise flexibility for conditions like this and we are fully aware of the major unmet need. Finally, I want again to thank you for coming today and I want to assure you we share the same goal which is to find a cure for this devastating condition and on the way to that, to find a new way to slow down the disease. If there are treatments that can be given before patients to be given before patients are symptomatic that certainly would be a very good area for targeting treatment.”

Eric Bastings, MD, CDER
9/22/2015
FDA Public Meeting on Patient-Focused Development for Huntington's Disease