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.
Agave nectar (sometimes called agave syrup) is most often produced from the Blue Agaves that thrive in the volcanic soils of Southern Mexico. Agaves are large, spikey plants that resemble cactus or yuccas in both form and habitat, but they are actually succulents similar to the familiar Aloe Vera.