Further Comment by Dan Weiss (author of Seeking Alpha piece)
I posted a comment asking why he thought the FDA consideration period would be longer than the usual 90 days for a 510(k) application. His reply was as follows: "The typical length is 90 days, however, APPY has a significant amount of information in the filing which will typically result in more communication between the company and the FDA resulting in a more realistic timeline being approximately 180 days (although its always possible the period could be shorter). In terms of market potential the appendicitis test has an overall market possibility of $1 billion or more on a global scale (which is not far off from the market size of HGSI with lupus considering that company's split with Glaxo)." He goes on to say that he expects the ELISA to be approved by the end of the year "with the hopeful full approval of the AppyScore test coming late next year."