Replies to post #34297 on Dakshidin Corporation (DKSC)

[Q7]

On May 21, 2020, the U.S. Food and Drug Administration (FDA) posted a list of antibody tests that
are being removed from the “notification list” of tests being offered

Hangzhou Clongene Biotech Co., Ltd. COMBRA COVID-19 IgM/IgG Rapid Test Cassette



https://www.tchd.org/DocumentCenter/View/7223/HAN-Advisory---List-of-COVID-19-Antibody-Tests-that-should-no-longer-be-used-in-the-US-5272020


? Health care providers and local laboratories should no longer use the antibody tests removed from the FDA notification list. Health care providers and local laboratories should review this list regularly.
? Published scientific data are insufficient to determine whether serologic assays can or should be used to diagnosis COVID-19. Additionally, it is unknown whether having IgG antibodies against COVID-19 means that the person has developed protective immunity and cannot be reinfected. Until more studies are completed, results from serologic tests should not be used to make decisions about disease control (e.g., stop wearing PPE). CDC is evaluating the performance of several commercially manufactured antibody tests for SARS-CoV-2 in collaboration with other federal organizations; results from these studies are pending.
On May 21, 2020, the U.S. Food and Drug Administration (FDA) posted a list of antibody tests that
are being removed from the “notification list” of tests being offered under the Policy for
Coronavirus Disease-2019 Tests During the Public Health Emergency.
Antibody tests on this removal list are those which have been voluntarily withdrawn by the test’s
commercial manufacturer and those for which there is not a pending Emergency Use Authorization
(EUA) request or issued EUA. It is expected that this removal list will continue to be updated.

[stervc]

God_Father, with this key thought with the tests...

Thanks for posting this. I think what's important to note, within that article, it clearly stated and indicated that there are two kinds of approvals that are being referenced. The kits have been allowed to be used in the US by the FDA while awaiting FDA approval. The FDA have given them FDA Registration Number 3009414546.

So in essence, the FDA is allowing them to use their kits in the US until they are granted FDA approval. Here is the PR again and what it reads:

https://finance.yahoo.com/news/proven-pharma-named-exclusive-distributor-140700389.html
The test has been submitted to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) and is awaiting approval. The FDA is currently allowing the test to be made available in the U.S. as the agency reviews its EUA application.

The FDA is allowing Clungene® SARS-CoV-2 IgG/IgM Rapid Serology Test to be made available under its new policy dated May 4, 2020 (Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency):
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised

Also, as for that example I had seen, if DKSC is selling Coke in their store and someone buys that bottle of soda, there is some kind of revenue to be generated for DKSC (or that store) from such from being a distributor or supplier or however one chooses to label such.

More from that PR...

https://finance.yahoo.com/news/proven-pharma-named-exclusive-distributor-140700389.html
...As required, the completed EUA template and associated documentation were submitted on May 15, 2020 to the FDA. The submission (EUA#201121) included updated validation reports and additional clinical data. Clungene's establishment registration & device number on the FDA's website is 3009414546.

...The manufacturer has performed two clinical studies of the test, both of which were submitted to the FDA, and Proven Pharma is in the process of conducting a third trial in the U.S.

Proven Pharma has distributed Hangzhou Clongene Biotech products in the U.S. since 2018. Proven Pharma has performed multiple site visits of the Hangzhou Clongene Biotech facilities for quality assurance and supply chain efficiencies. Founded in 2004, Clongene is registered to sell 24 products in the U.S., according to the FDA, including the Clungene® SARS-CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Cassette.

To conclude...

From the very article that was posted, it clearly stated...

https://abc7chicago.com/covid-19-antibody-tests-faulty-test-fda-list-of/6202583/
Under pressure to increase testing options, the FDA in March essentially allowed companies to begin selling antibody tests as long as they notified the agency of their plans and provided disclaimers, including that they were not FDA-approved.

From the other article that was posted, it clearly stated...

https://www.nbcnews.com/health/health-news/unapproved-chinese-coronavirus-antibody-tests-being-used-least-2-states-n1185131
On March 16, after the Department of Health and Human Services said the pandemic justified the authorization of emergency use of diagnostics for detection and diagnosis, the FDA relaxed its policies, allowing tests to be sold even if it had not approved them.

Now read again the info from above and the post below:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=157618437

For me, I'm willing to take the risk to see what more is going to be coming from DKSC and its wholly owned subsidiary, White Chapel Holdings.

v/r
Sterling