A few subtle items this past week and at the annual meeting are pointing towards close coordination between the FDA and CMS that for us implies some reasons for optimism: 1) a clarification on age guidelines had some body language in the queryby the CEO of Dr. Berger that "the label says up to 84 years-doesn't it?" Note the reference to "the label." Good progress behind the scenes...?! 2) CMS is obligated for the first week in September after 1 week of comments to the crosswalk presentation and we doubt, with the paralled coordination between the FDA and Medicare, that CMS will delay their whole package for the G-code (part of larger issue resolution) for an FDA decision. Hence, it seems that there may be coordinative pressure on FDA to get the decision on Cologuard out prior to the issuance of the G-code, not to mention that Cologuard has demonstrated efficacy, safety, and the saving of lives. In other word, CMS is living up to its end of the historical "parallel process...?!" Conroy encouraged sharehholders to get their comments in...! 3) Kaiser stats imply they raised FIT/FOBT tests from 30-40% compliance to 70-80%. That implies that for 10MM tests there were 20MM-30MM prescriptions written...?! At $500, this could add $3 billion with little effort?! Hence, Cologuard has a higher number to displace than originally thought with follow-up programs by EXAS! 4) Conroy clarified some progress on the molecular platforms for the pipeline of pancreatic, IBD and esophogeal cancers. Pancreatic cancer is very slow growing (up to 30 years) and with high mortality. So, these applications could add another $2-$3 billion WW in tests in the future." These subtle clarifications and data points indicate that everything is moving towards converging, positifve events that could lead to a $40-$60 valuation by September. Be patient, the details are painting a rosy, life-saving picture whether you are a fan of Cologuard for $$$s or saving your life. Yesterday's $15.99 price is a gift.
Heard pretty much the same from a friend who also attended the meeting.
The point that you make about the Kaiser compliance rate cannot go unnoticed.
So many scripts are written for FIT, but only a few actually get complied with and turned in.
Plus, with FIT you actually have to reach into the toilet bowl and handle the sample. Not fun.