Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Fast Company, in “What It Will Take for Theranos to Make a Comeback,” by Christina Farr.
Following is an excerpt:
As he points out, Theranos made a grave error in hyping up its range of tests too early in its development. The company has only received a clearance from the U.S. Food and Drug Administration, or FDA, for one test: A $9 finger-stick test for herpes. But in the year prior to that approval, the company had heralded its technology as revolutionary and claimed to test for "hundreds" of diseases with a few drops of blood. It'll be very difficult to come back from that.
"They did all that promotion on the basis of inadequate data," he explains. "I imagine anything they release now will be greeted with skepticism." After a career helping companies navigate FDA regulations, he notes that a two-year lab ban on a company executive isn't something that an agency would ever take lightly. "They do it precisely because they've lost trust," he says.