Biotech Values

[walldiver]

DNDN--It wasn't until Sept 2005 that the company was able to meet with the FDA about the feasibility of filing the BLA based on the 9901 trial, with 9902A to serve as the supportive study via the FDA's usual rule of thumb of having one stat sig randomized study and one supportive randomized study. So it's not quite a full year yet. Also, subsequent to 9/05, the company had to complete negotiating the amendments to the 9902B SPA, which they did in late November. They also had to break ground on the new mfg facility, moronically time a shelf offering smack in the middle of tax-loss selling season, and come up with a strategic realignment plan of the company's resources to focus on the dual preparation of the BLA and the mfg facility. So, there has been a lot to accomplish since the unblinding of 9902A, and they have continually said that their goal is to complete the entire BLA by 12/31/06.