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.
The plant Agave americana, which is sometimes called American aloe, belongs to the Asparagaceae, a different family. The genus is native to tropical and southern Africa, Madagascar, Jordan, the Arabian Peninsula, and various islands in the Indian Ocean (Mauritius, RÃ©union, Comoros, etc.).