Going forward, FDA has indicated a willingness to extend that accommodation further upstream in the process. Roughly 72% of the BTD denials relate at least in part to trial design or analysis problems, which suggests that sponsors must do more to engage with FDA prior to submitting their request.
Soave, from the Veneto in North East Italy, has a reputation for producing rather neutral, boring white wines. Its partly deserved. Pop into your local supermarket and buy their cheapest Soave. It will be a commodity wine, with some fresh acidity but rather neutral flavours.
While its name would indicate otherwise, the city of Southaven is actually in the northernmost corner of Mississippi. The name derives from the fact that Southaven is located south of Whitehaven, Memphis. Southaven hosts the Central Hockey League team, the Mississippi RiverKings, who play at the DeSoto Civic Center.