It appears the DREAM-HF trial definitely presents a conundrum...

It appears the DREAM-HF trial definitely presents a conundrum for the FDA.

It very well could be unethical to perform another trial for heart failure patients with diabetes and MI considering the benefit gained over the control group who were given maximal standard of care therapies. I suspect another trial could be requested for other aspects of the DREAM-HF trial that could be considered hypothesis generating, but what is not so clear is whether the FDA could request another trial that includes the pre-specified diabetic/MI subgroup.

So I take it the FDA will next request the multicenter study to be broken down to single sites to identify any potential biases in these subgroups prior to agreeing on a potential pathway to approval, which could include an application for registration and priority review designation? Considering the strength of the results and endpoints, the added benefit, safety profile, durability and the fact it's only a single injection, it's looking plausible.