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.
Sopes with green salsa. A sope (Spanish pronunciation: [Ëso.pe.]) is a traditional Mexican dish originating in the central and southern parts of Mexico, where it was sometimes first known as pellizcadas. It is an antojito which at first sight looks like an unusually thick tortilla with vegetables and meat toppings.