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.
Of these, Anselmi no longer uses the Soave DOC: instead he labels his wines as IGT Veneto. It has to be said that this was a rather select bunch of wines tasted here, but none the less I was surprised by the interest and quality demonstrated. As with many more serious Italian wines, they are underappreciated in the UK.