Re: The Analyzer and testing
in response to
by
posted on
Mar 14, 2015 07:35AM
Paramagnetic Beads and QL Analyser are Proprietary Products
The company already answered question 1 and 3. Look at your post "Testing Status".
As for question 2, I would assume that the testing was fine since they stated : Once the pilot testing is concluded, testing for regulatory approval will be initiated.
From the 10K, page 8
"Currently, our TnI test product is in the pilot testing phase. Although pilot testing is approximately 50% complete, testing has been suspended until the Company can raise additional funds to cover the remaining costs associated with the pilot testing program. Once the pilot testing is concluded, testing for regulatory approval will be initiated. The filing for U.S. and European regulatory approval is expected before the end of 2015. Upon receipt of FDA approval, we intend to market the QLCA and the Cardiovascular Tests through a major IVD distributor. We have initiated preliminary discussions with several of the Tier 1 IVD companies, and we anticipate that we will commence negotiations with one or more distribution partners before we receive FDA approval. In accordance with industry practice, we intend to enter into a license agreement with our distribution partner for the manufacture and distribution of our products."