March/April has been the guidance for the data release.
That has been known for awhile for anyone that has listened to the Company. As for "risks", if the data is solid the Company will be in a massive sprint to launch in Q1 of next year. They've already been preparing. One look at their Job Openings section on their website will tell you as much. Their lab in Madison is becoming CLIA approved.
The execution risk is GONE, if the data comes in solid with the primary endpoint being Cologuard vs Colonoscopy and the secondary endpoint being Cologuard vs FIT for detection of cancers AND pre-cancers.
As for Sales traction, I think that you'd be surprised to learn (if you listened to a conference call or presentation made by the management team) that 60% of the FIT tests out there are generated by just 6% of the primary care physicians. That means that just 6% control about 6 million annual FIT tests. It won't be difficult targeting those 6%.
What is really the KEY here is CMS reimbursement.
And this is a unique situation given that CMS has invited EXAS into a pilot-program by which CMS reimbursement will occur no later than 90 days after FDA approval.
This is unheard of.
It usually takes anywhere from 18-24 months AFTER FDA approval, for CMS to approve reimbursement.
And that has been the "killer" in the past for medical diagnostic companies.
This is ALL PUBLIC INFORMATION.
It's mind-boggling that some of the people here that have capital at risk are clueless to the fundamental basics and refuse to spend 30 minutes listening to the last earnings call from February ... yet don't hesitate to make grandiose unsubstantiated claims.
Strange.
