Landis82
Registered: Jul 2006
Posts: 8580 |
01-18-13 04:29 PM
The FDA clinical trial for EXAS should be completed within a couple of months, with the top-line data from their "Deep-C" study announced in March.
The "Deep-C" FDA clinical trial will encompass 12,700 samples. The single biggest clinical trial ever attempted for a colon cancer screening test!
CRC is the #2 killer of Americans over the age of 50.
It costs Medicare $14 BILLION per year!
The manufacturing module was submitted back on December 7th.
The analytical module will be submitted in early February, with the final module... the clinical module submitted in March.
There is a parallel application to CMS/Medicare.
The Company will have CMS reimbursement within 90 days of FDA approval, instead of the usual 18-24 months that it has taken in the past, due to a new "fast-tracking" pilot-program that EXAS is involved in with CMS.
Buy the dips!
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