By that, I'm referring to the upcoming FDA review that is scheduled take place on March 27, a little over 3 weeks from now. The fact remains, there is so very much potential for this test if endorsed by the FDA, that the company has an uncontested, unrivaled 3 BILLION dollar market opportunity on it's hands. HOWEVER (intentional caps here), IF the FDA rejects Cologuard as a superfluous and ineffectual adjunct to colonoscopy, the stock will likely fall to less than 25% from where it stands today, (or, below $4.00).
Place your bets ladies and gentlemen. We will have clearly identified a large number of "fools" by April Fools Day, no matter which side the FDA comes down on.
Just remember, "binary event" means there are only two possible outcomes. It *does not* mean that both outcomes are equally likely. I don't think that anyone who's looked at the results of the study feel that it's likely cologuard will be turned down. It's possible that's true, but even knowledgeable shorts know that betting on cologuard being rejected by the FDA is a long shot. Place your bets and hedge your positions accordingly.
You are wrong about the upcoming event, it is not binary, it is the single most important test for CRC screening since colonoscopy. Millions of people will be screened who would not otherwise consider due to its accuracy and non-invasive process. There is little doubt that this technology works, it will reduce mortality rates and from an investor's perspective there is the potential for many, many events ahead that will propel this little company into greatness. Sell some when " $hit happens" hold some for the ride of your investment times!
Even shorts have admitted on numerous occasions that cologuard will gain FDA approval when they write their published articials of condemnation .Their argument is compliance for the reason for failure, not FDA approval being denied.
Sentiment: Strong Buy
Cologuard is not superfluous since it provides a non-invasive method of cancer detection with performance similar to a screening colonoscopy. Even if it were, the FDA does not reject applications based upon whether or not something is superfluous.
The top-line data shows that Cologuard is superior FIT, which has gained FDA approval, laying to rest your "ineffectual" argument.
The EXAS CEO has repeatedly gone on record stating that the Deep-C Clinical Trial shows results clearly superior to FIT and unlike FIT, also good at finding precancers. I'm sure the FDA panel will be also be made aware that EXAS will be adding markers to find other cancers along the digestive tract, including pancreatic for which there is no non-invasive screening test. With tremendous pressure at the national level to reduce heath care costs, the FDA review panel would have to justify their negative decision in the face of overwhelming evidence to the contrary.
None of us know for certain the outcome of the FDA's decision, it would certainly be a bummer for the parallel review program to have its first test case fail the process. That certainly would not encourage others to participate in the future. Curious if the Longs are hedging against the unexpected and wondering what the shorts are doing to hedge against the expected.
Kind of hard to be concerned, as the management seems extremely confident of moving forward. Check out Exact Sciences website and look under careers. They are ramping up big time!!!!
Sentiment: Strong Buy