room with the results, and these guys would come back in and say, oh, here s your results from running our test. we had listed on the web page, like, 200 different assays. we had no more than half of those actually validated to be working even in the lab at that point, let alone on the edisons. because it s trying to do multiple analysis. you need so much hardware inside the machine, it was totally impra impractical. they were very adamant about the machine being this big. it s got to be this big. i said, we can t do this. the laws of physics don t allow us to cram all this stuff that we decided that needs to go in there into this little box. can the box be bigger? and a common response at theranos was something along the lines of, maybe you re not a silicon valley person. maybe you should go work for another person if you don t believe in the vision of the product. and what would start off as a
the fda with vague, exploratory letters, trying to stall for time till the edisons could do all the tests that theranos advertised. and that could take years. in the meantime, the theranos operation in palo alto was being regulated by cms, the federal agency in charge of clinical labs. theranos was also playing games with them. even though some patient tests were performed on edisons, theranos never reported those. the company only gave cms the data from third-party machines. the decision was, let s send what was on the imulate and the semens advia. let s not send the edison results. that really freaked me out because that was suggesting, okay, we didn t trust the edison test. here we were able to make that discernment of what was the appropriate one to send, but we weren t doing that with patients. and when cms came in for the inspection, sonny and elizabeth only showed them the lab with