Wednesday, June 17, 2020 2:43:48 PM
A few things I no longer like about the current situation, but for which it is impossible to have a firm conclusion:
1. SEC website hasn't posted a response from DECN to May 20th filing and we are now 2 weeks past the June 3rd date. Either DECN didn't file or SEC is delaying (intentionally) the posting of the company response. Neither is a good scenario.
2. Today's PR, while positive on its face, also reveals however, that previous testing and their results were not satisfactory or providing accurate results and so the company is introducing a design change that it hopes will correct/improve the test results. Sounds great. Nevertheless, this means the company has been withholding the test results from us for a period of time that were previously promised to be revealed and the main comment in the PR is that the results will be faster.
However, it was previously stated that the tests had been tested and supposedly accurate. Well, since the HCT will now be included in each phase of testing, it means testing has to start over or the lab testing for FDA EUA never occurred. Neither of these are good scenarios as it means the company has not been truly transparent as to what stage and where development of the test strips are at.
Yes, they are making arrangements for distribution in foreign countries, but what is necessary for those countries to approve the sale of the kits and where is the company in that process?
Also confusing is that previously, the company described how lysing the blood cells was critical to be able to detect and get results for the existence of COVID-19. Now, today, the PR states that lysing won't be needed at all. I'm not a scientist, so I don't know what this means, but it sounds like the "final design" of the test kits has not yet been tested and so, while impedance technology can always provide rapid results, nothing has truly been stated on letting us know about the accuracy and ability to provide true and accurate results other than the early March PRs if I recall correctly stating that the test strips had already been tested in Daegu and the inference was that they worked.
The radio interviews stated that the company had a COVID-19 test and that it worked. It doesn't work just because it provides a result in 15 seconds. The inference is that it worked and had been thoroughly tested.
Today's PR reveals it had not been tested to a point where it worked sufficiently and it would be good to know what the tests actually revealed.
Because of this, I'm out until approval or true transparency of where and what testing has been done.
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