…are the words you really never want to hear, unless you are Amicus Therapeutics. In a rare reversal, the FDA, under the leadership of Scott Gottlieb, told Amicus Therapeutics they didn’t have to run expensive and lengthy safety studies before seeking FDA approval. Under the previous FDA leadership, Amicus was told to conduct extra safety studies, namely for GI symptoms, for their Fabry disease candidate migalastat. Many in the pharma industry are heralding this as a new era at the FDA. It’s a good time to be a biotech lately. As of press time, the iShares Nasdaq Biotechnology Index (IBB) is up 5.4% the past month, 7.1% over the past three months and 16.8% on the year. Can you hear that? That’s the sound of the VC community raising more money.