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Korrekt, Umsätze sind erst ab Anfang Januar möglich, da erst am 31. Dezember das CE Mark erhalten wurde. Verkäufe sehen wir im nächsten oder übernächste Quartalsbericht. Ich erwarte aber ein paar LOIs.
Sona Secures Clinical Trial Authorization and Hospital Partner
This news release constitutes a ?designated news release? for the purposes of the Company?s prospectus supplement dated April 9, 2021 to its short form base prospectus dated March 31, 2021.
Halifax, Nova Scotia?(Newsfile Corp. ? April 12, 2021) ?Sona Nanotech Inc. (CSE: SONA), (OTCQB: SNANF) (the ?Company? or ?Sona?) a developer of rapid, point-of-care diagnostic tests is pleased to announce that it has been granted Health Canada Investigational Testing Authorization for a clinical trial of the Sona Saliva C-19 Rapid Test, a saliva sample-based rapid COVID-19 antigen test, with the Humber River Hospital in Toronto. The trial is expected to commence shortly, following final ethics review board sign-off of the trial protocol amendments required by Health Canada. The trial?s objective is to determine the clinical performance of the test when compared to RT-PCR, in symptomatic patients. Analytical validation studies would also be required to support any regulatory submissions.
David Regan, CEO, comments ?New, less invasive rapid tests are needed to support frequent testing and a test that works with saliva would make regular testing for everyone much more accessible and tolerable. Developing a rapid antigen test for COVID-19 that works with saliva is complex, as evidenced by the absence of any FDA or Health Canada approved saliva sample-based rapid COVID-19 antigen tests. Sona has invested several months in the laboratory to adapt and optimize the performance of its test to enable it to work with saliva samples and we look forward to working with the Humber River Hospital on this trial of our saliva test.?
I see and recognize a renewed interest in Sona Nanotech so I would like to take this opportunity to post a brief summary of recent events. I will use official sources and mark my own comments and possible speculation with a *. Let's get started!
Long time we didn't hear from Sona, the last NR from Sona was released on 12/31/20, a nice gift for New Year's Eve. "Sona Nanotech Receives CE Mark Approval for its Rapid COVID-19 Antigen Test" A great news, since then Sona has the permission to sell its COVID-19 Lateral Flow Assay in Europe.
Then on 02/18/21 a sudden rise in the SP, just before the close. A little later we heard a rumor *This run is related to saliva field results coming back at 99%.* Actually there is some truth to every rumor.
We received the next NR from Sona on 03/23/21 "Sona Announces Filing of Preliminary Short Form Base Shelf Prospectus". Great news, Sona now has the opportunity to raise up to $20,000,000 via an ATM shelf offering. You don't do something like this without an ulterior motive. To me, this NR was the most serious NR in Sona's history.
On 04/10/21 the ATM offering was officially confirmed. When exactly Sona activates the ATM we don't know but it says in the NR's"
The Shelf Prospectus, when made final, will enable the Company to offer up to $20,000,000 of common shares, debt securities, warrants, subscription receipts and units (collectively, the "Securities"), or any combination of such Securities from time to time, during the 25-month period that the Shelf Prospectus is effective.
Under the ATM Offering, Common Shares will be distributed at trading prices prevailing at the time of the sale. As such, prices may vary between purchasers and during the period of distribution. The volume and timing of sales, if any, will be determined at the sole discretion of the Company's management and in accordance with the terms of the Equity Distribution Agreement. As of the date of this release, no Common Shares have been distributed by the Company under the ATM Offering or pursuant to the Equity Distribution Agreement."
Then suddenly we received the redeeming news and it was on 04/13/21. "Sona Secures Clinical Trial Authorization and Hospital Partner" Up to this point, we shareholders are completely in the dark. I just spoke of the most serious NR in Sona's history but this NR was even better. "Sona Nanotech announce that it has been granted Health Canada Investigational Testing Authorization for a clinical trial of the Sona Saliva C-19 Rapid Test, a saliva sample-based rapid COVID-19 antigen test, with the Humber River Hospital in Toronto. The trial is expected to commence shortly, following final ethics review board sign-off of the trial protocol amendments required by Health Canada"
Sensational news! Also at Health canada we are now listed again under the approved studies section.
Speaking of videos, though, I forgot one thing. Shortly after the 99% rumor, a password-protected video was uploaded to the Sona Nanotech website, probably for study purposes because in the domain we find the combination RUO, Research use only.
On 04/22/21 another sensational news, is there actually an increase of most serious? "Sona to Commence Clinical Trial for COVID-19 Rapid Saliva Test" The Ethics Committee has approved the trial and it will start next week. A little from the NR: "Sona Nanotech is pleased to announce that it has received research ethics board approval for its clinical trial of the Sona Saliva C-19 Rapid Test. The trial, which will seek to test up to 500 emergency room patients suspected of having COVID-19, is expected to commence next week. The Company will update the market with results from the trial upon completion.
Clinical trial principal investigator, Dr. David Jacobs of Humber River Hospital, comments, "With the third wave now upon us, frequent rapid testing is crucial to identify COVID-19, limit spread, and decrease hospitalizations. This clinical trial is an important step in exploring the use of devices that are both more comfortable for the patient and safer for those administering the tests to ensure rapid and accurate diagnosis. Our primary concern will always be the proper care and treatment of our patients, and the safety of our front-line emergency room staff."
Dr. David Jacobs: I'm excited to announce that I'll be leading a clinical trial at @HRHospital investigating @SonaNanotech's #COVID19 rapid saliva test. Developed in Halifax. Manufactured in Toronto. Hopefully a game changer. The trial commences next week!
Now I want to talk a little bit about the Form 8 of 04/09/21 because there is some very interesting information there.
"Sona intends to use existing cash on hand to fund this trial (HC), which Sona anticipates could have a total cost of approximately $100,000 and is expected to deliver results within four to ten weeks of commencement, depending on prevalence of the disease at the time of the trial and resulting availability of a sufficient number of COVID-19-positive test subjects as are necessary to complete the trial."
We see that at this point Sona could only estimate how much time the study would take. As of today, we are in the middle of the third wave, there are more COVID-19 patients than ever before, Humber River Hospital is on the verge of collapse,* this trial will be completed very quickly in the current situation. I also want to clearly mention that Sona is testing symptomatically, that can be up to 100 participants a day at the Humber. * So I personally assume 4 weeks or less.
We are still in the Form 8. "If that trial is successful, Sona intends to commission the third-party analytical studies necessary for a submission to regulators. Sona expects to use a portion of the net proceeds of the Offering to fund these further studies, which Sona believes could cost between approximately $350,000 and $550,000. "
After the hopefully successful study, Sona will conduct third-party analytical studies. In return, the ATM will be activated at a presumably much higher SP, the dilution will be minimal.
Further clinical studies may also be commenced to support claims for authorization of multiple configurations of the test, to include, but not limited to, the use of the test in asymptomatic populations and self-testing. Sona expects to use a portion of the net proceeds of the Offering to fund these further clinical studies, which Sona estimates could cost between approximately $300,000 and $500,000"
I find this part particularly interesting because it will probably be an American study, which would be sensational!!
That would be Sona's ticket to the FDA. *Personally, though, I think Sona will apply for an EUA very soon, study data can probably be submitted later.
The shelf offering, by the way, is conducted by Canaccord Genuity Corp.. Canaccord Genuity Corp has sold about net $306,693 worth of stock since 04/10/21. Coincidence?
Last but not least, Sona's milestones:
Securing clinical trial for COVID-19 saliva test: April ? June 2021 - CHECK
Clinical trial results for saliva test: four to ten weeks from trial commencement
Results of analytical studies to support saliva test submission to regulators: Following trial conclusion
European CE Mark designation and potential submissions to regulators: Following analytical study results
* Deutsche Bank Real-Time Indikationen basieren auf Preisen von der Deutschen Bank emittierten Produkten. Diese Produkte versuchen, den jeweiligen Index 1:1 zu tracken.
Die Preisstellung erfolgt börsentäglich zwischen 09:15 und 17:15.