The following is a reply i received to an email I sent Ralph in mid January. i have not been in touch with the company since then.
It will be interesting to see if the company will make an announcement to the ASX if they are notified by NanoDx that they have made their submission to the FDA or will they wait until EUA granted. Regardless, I do not expect it to take more than 2-3 days for the FDA to grant the EUA after receipt of submission. Hopefully, EXCITING days ahead !
Ralph emailed (exact wording)
"I am sorry to hear that investors are leaving due to not fully comprehending what we do and the value of that. Bottom line is we will be selling unpackaged sensors. These are microfluidic devices that take fluid and supply electrical information to a reader.
We build all our products on wafers. Once fully processed these wafers have hundreds of sensors. We ship these sensors and they are packaged in plastic carriers (by someone else as this is not our competency) to be inserted in the reader. To say this is a straightforward wafer is ridiculous. This is a highly sophisticated unique structure with days of processing with unique materials that when combined form the sensor. It took 18 months to develop with many PHD level people at the customer and Sensera to make operational. The information extracted from the sensors we provide is then put into a software algorithm in the reader that determines if a person has COVID or not.
Hope this helps but whatever “definition” people want to use for what we do, we will ship millions of them and have potential to ship at least $10M worth of product at 45-55% gross margin (all previously publicly disclosed). Our limitation will solely be the equipment to process and how much output we can get."
