Therma Bright Inc V.THRM

It occurs to me

[Bakunin6]

That we don't need hc or fda approval to sell in asia.
Perhaps that's why the k-one tone was full speed ahead...
With our primary Asia-based manufacturing partner, K-One MediTech, in place we are ready to begin production of our CE-approved AcuVid™ COVID-19 Rapid Antigen Saliva Test....and
 K-One MediTech will be granted the primary manufacturer rights for Asia of the Company's AcuVid™ COVID-19 Rapid Antigen Saliva Test Kits for a period of two (2) years commencing from the 1st production batch for the commercial market

[stockmonster6]

Correct. Those approvals are only for USA and Canada. They are good stamps of approval, especially FDA, but are not what is required in Asia.

[forrest6748]

But don't,t forget for the FDA:This wil surely help.. K-One Meditech, an ISO 13485 certified company, is a well-established medical device manufacturer registered with the FDA to supply medical devices and products

[TheeRook]

They are not  into testing devices.  This is all new for them so that is why no production until the 4Q. Currently  K-One is a Medical Supplies Provider We manufacture and distribute nasal swabs, ventilators and syringe safety needle caps to the healthcare industry. Which all have to be FDA approved to be sold in the USA. Medkaire Ventilator is manufactured by K-One under

[Bakunin6]

Im thinking they're going to start making them now for asian distribution. If it works, it works...why wouldn't they? what's stopping them? 

[TheeRook]

Approval. Each country has their own Medical Device Authority (MDA) Even in Malayasia  what they make has to be approved before commercial sale.

[TheeRook]

THRm ACUVid is still  missing the Limit of Detection,   PERFORMANCE CHARACTERISTICS and CLINICAL PERFORMANCE   data from their published information. Take a look at  the FDa Approved BinaxNOW™ COVID-19 Ag Card to see what is missing. https://www.fda.gov/media/141570/download

[Skipabeat22]

This could be why the results for Brazil are taking longer as they are putting all the data together to have a package to submit to the different Health Authorities in their respective countries.

[Smokey1958]

I don't know what your problem is TheeRock but THRM has been very clear on their results. In fact the results as presented on their website are conservative compared to what they appear to have achieved recently. If you were to look, which you're not, at all the evidence both with THRM and those countries that have enbraced rapid antigen testing, you would see that THRM is on track to

[Boudi1959]

Correct Smokey1958, he always appears when something is happening Just to leave people doubting!