Sona Nanotech Inc C.SONA

Interview from Friday

[Hightide22]

From the CEO Lexy911 Great interview with David Regan CEO David Regan was downplaying the news and indicated in an interview Friday that the decision by the Food and Drug Administration wasn’t totally unexpected. A developer of rapid, point-of-care diagnostic tests, Sona was informed by the FDA on Thursday that the company’s request for emergency use authorization for the marketing of its rapid COVID-19 antigen test in the United States “is not a priority,” which meant such authorization was not issued. Regan told me the FDA had recently updated the template for rapid antigen test applications, “and while we submitted (an application) some time ago . . . under their prior template, (the FDA) updated their template which put greater emphasis on the ability to distribute and manufacture. So, we figure that had a big bearing (on the decision).” Although Sona indicated the FDA decision did not comment on the performance of its test, Regan said he figures the fact that Sona is a small foreign company and not a large U.S. firm with significant capacity to manufacture and distribute tests was also a factor. Now, rather than focusing on the market of 360 million people in the United States, he said, Sona will be satisfied to concentrate on the Canadian market of 36 million people, “which is certainly a better match in terms of our ability to service demand.” Regan said Sona has limited manufacturing at its facilities in Dartmouth but the company has a contractor in England ramping up to begin making the antigen tests once Sona has been given permission to take it to market. But Health Canada has not yet approved the rapid COVID-19 antigen test, although the company has received additional questions on its application. Also, Health Canada has submitted the company’s tests to the Public Health Agency of Canada’s National Microbiology Laboratory for evaluation, which is ongoing. “We’re engaged with Health Canada, they’re working hard on it, we’re working hard on it,” Regan said. “You know, one of the challenges is (determining) the best use of these rapid tests, particularly in Nova Scotia, where we don’t have a backlog for (polymerase chain reaction) testing.” The best use for Sona’s 15-minute rapid antigen test would be at a single location, such as a nursing home, he said. The test would provide almost instant feedback on staff, visitors or residents who may have come in contact with the COVID-19 virus. The goal of the Sona product is not to be used in a doctor’s office to make a diagnosis, Regan said. “This is perfect for screening.” The company’s antigen test has been described as being a pregnancy-type lateral flow test that is easy to administer and interpret by non-experts without the need for either laboratory equipment or a device to read its results. Sona has large employers looking for a quick way to screen their workers to determine if anyone has been exposed to COVID-19, Regan said. If the antigen test indicates someone is positive, then they could go to a doctor for confirmation. “Our best use for this rapid test . . . is more for reopening the economy rather than a medical system device,” Regan said. “The challenge is it can only be sold if you get Health Canada approval.” At Health Canada, the only certification category for COVID-19 testing is for a medical diagnostic point-of-care device, he said. “And so it’s held to a very high threshold and yet everyone knows it’s not going to be used for that.” The company has reported that its antigen test showed 85 per cent agreement to polymerase chain reaction results in patients in an in-field study of 99 patients, and 96 per cent sensitivity in laboratory studies. The Sona lab in Dartmouth is steadily working on improving the tests using the company’s proprietary, patent-pending, gold-nanorod technology, he said. The next generation of test will use saliva samples but, Regan said, saliva tests will require a strong and large trial base before getting approval from health authorities. Sona is engaged in talks with several high-profile study groups about a trial of the saliva test, he said. Source: https://www.saltwire.com/business/local-business/roger-taylor-dartmouths-sona-nanotech-continues-on-despite-fda-rebuff-515479/

[zoe18]

[The devices referred to PHAC-NML for scientific evaluation by Health Canada include test devices with potentially good performance (such as data to support good sensitivity or specificity) and: that are fundamentally different from others in its class from manufacturers that are new to the Canadian regulatory environment for medical devices from manufacturers that provided

[Moemoney42]

Well this interview sure pokes a hole in alot of pumpers BS as well as the companies double talk via the tweets that were coming out lately..!!

[Hightide22]

You may have been right on a few points but the way you present your opinion gets many to attack  or to take you as a basher. There is nothing wrong in being humble when presenting your opinion. Your Sell at $16.00 was on the day it hit $16.00 not before and you make it like you called it and continue to drive home the point. after that you didn't call a drop or another high but came

[Moemoney42]

Well Hightide here's where you're wrong too... I called the SELL the morning of the day it crossed into $16+ territory so get your "facts" straight.. I've posted the post and time stamp many times.. if you don't want to recognize it that's your problem... its "FACT"..!! By the way.. the way I've been attacked by the pumpers the "arrogant tone"