Post by
wm23four on Oct 29, 2020 7:41pm
Speculation on earliest time frame for HC approval
Bummed that FDA categorized Sona test as "not a priority". Unbeleivable. Cases in US are soaring. Yet US FDA decides that Sona rapid test is not a priority. Hard to believe.
So, we now hope that HC approves, and soon. Have some questions and hoping to get some serious feedback. Wondering what could earliest time frame for HC approval be? Keep in mind, HC category is now back to manufacturer for reply to their questions. (This is 3rd req for addl questions.) So, Sona needs to again reply and HC needs to review the response. How long will it take Sona to respond and how long will it take HC to review the response? Mr. Regan has not yet replied to my question on this.
Additionally, todays PR indicates that HC "has submitted the Company's tests to the Public Health Agency of Canada's National Microbiology Laboratory for evaluation, which is ongoing". Wondering if anyone knows when it was first sent to this lab. And how long is this process expected to take?
Once these questions are answered we may have better idea of expected time before HC approval. Some have suggested we could get HC approval as early as tomorrow. That would be great, but not sure that is in the cards. I am initially thinking it will be a minimun of two weeks, possibly longer. Base this on how long it took the Saudi lab and hoping canada lab will be faster. But to be honest, have no idea.
Any serious thoughts/ speculation welcome.
Comment by
jada13 on Oct 29, 2020 7:58pm
Trumps in power and he has the HERD mentality because he knows it will take along time for a vaccine and economically people have to work .No matter the cost to human life.And dont forget its America first and foremost,no Canadian company is going to make money where a US company can.
Comment by
JonT88 on Oct 29, 2020 8:00pm
Then why did VST get FDA approval?
Comment by
JonT88 on Oct 29, 2020 8:53pm
I'm just saying they are a Canadian company
Comment by
jada13 on Oct 29, 2020 8:04pm
2 weeks at the most or its all over in my books.
Comment by
Waco4505 on Oct 30, 2020 6:50am
The Company continues its manufacturing scale-up activities, having run multiple pilot production batches with a contract manufacturing organization, and is in advanced discussions with other manufacturers. The Company expects to be in a position to ship commercial tests to customers in November, subject to regulatory approval.
Comment by
Lovethegains on Oct 30, 2020 7:02am
If SONA reads on here, they really need a NR or CEO interview out now to calm investors. Imo