They won't be running another Phase 3. And the results from the recent Phase 3 weren't all that impressive. So the question on the table is whether Exact can figure out a way to capitalize on mediocre results. They don't have a second product to fall back on, so it's the colon test, or nothing. I'm afraid the writing is on the wall, and a slow bleed to low 2's is inevitable.
EXAS has little chance of getting FDA approval. Specificity not worth the cost.
Plus with current system of stool samples and a colonoscopy every 5 or ten years you get the same results but with a colonoscopy, the doc REMOVES the polyps DURING the colonoscopy.
EXAS is ame story as MELA a couple years ago.
Except the EXAS CEO can hype better than MELA's could.
Time to short this puppy to 0.
So colonoscopy is used as a screening test and yet most people having one do not have polyps removed, which means that it was unnecessary in the first place. That would equate to what I would guess is 5% specificity?
Given that Cologuard's performance exceeded the requirements stated by the FDA, EXAS has an excellent chance of gaining FDA approval. If you are using the argument that the 87% specificity not being worth the cost as a reason they would not gain FDA approval, you are confused. The FDA does not consider "worth the cost", they consider safety and efficacy. The specificity will be used as one metric to determine the reimbursement price that CMS will offer, not FDA approval.
Colonoscopy is fine, but people are not using it. That's why colon cancer accounts for the second highest mortality rate of all cancers.
Uhhh - This wasn't a phase three trial, please explain, with all your implied knowledge, why you think the results were mediocre with respect to the non-invasice competition. Reading between the lines, I get the feeling that you don'[t have any insight into this stock.