RE:Speculation on earliest time frame for HC approvalwm23four wrote: 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.
So here are my thoughts on this. A bit of background: I was invested in Sona in February, I got most of my money out pretty early (Mid may). I sold the last bit of my sona position about a month ago. I have been called a basher by a lot of people on this board, but honestly, I was hoping Sona would work out, and there would be a vialbe test mass produced.
Here are my thoughts on Sona:
I think "not a priority" is a polite way of saying "This test does not meet the minimum standards". Rapid testing is still a priority in the USA, just not the sona test. Why would the FDA reject a test?
Sonas managment have not been transparent about the size of their studies or what the results were. . Other companies are getting approval daily now, some tests are being used as "research use only" (but validated independantly). To me that means Sona misses something major as no one uses it. No sales reported means no one uses it.
Secondly, they did their most important validation in the middle east. Why not use any of the hundreds of outstanding north american CRO's that could perform the test? Did they run out of cash? Who knows!? It was just suddenly done in Saudi Arabia. I would understand a bit better if the CTO or CSO was from the middle east and had contacts there, but nope, just no explanation.
Additionally, as I understand it, the national laboratory already did test their product, and it didn't work. The sona guys did some hand waving to explain "that the samples had been heated" or something like that. I tend to wonder if the test just didn't work, and the Sona guys just had to come up with an explaination. Seriously, throwiing shade on the national laboratory as if they don't know how to run the test was a bit desperate sounding (https://sonanano.com/sona-nanotech-provides-covid-19-antigen-test-progress-update/)
I might buy back in, if it goes under $1, but only if they explain what happened, and it makes sense. I feel bad for the people who bought at $16, but this company was showing obvious problems since May/June. Without believable news from the management, I think this company is not to be trusted. But that news might come in 2 hours or 2 weeks...