I like that he addressed the question about "how can you achieve this by the end of 2014" because I think a lot of people misunderstand the process they are using. CLIA is not as involved as FDA approval which is why they chose to go this route and will continue to work toward FDA approval. Also, diagnostic trials are different than drug trials in their makeup, complexity, and timeframes. Dr. Kirby's experience is key here as GC mentioned. Read Dr. Kirby's quotes from Tuesday's PR and it should make you feel much more comfortable with where things are going. Glad the blog came out even though a lot of it went over my head.