Since our Covid customer has had a previous application on a similar platform approved last year by the FDA, I believe our Covid customer has been working together with their contacts at the FDA for the past 5 months in relation to the their Covid diagnostic platform.
Our customer knows exactly what the FDA requires from them and want to ensure that once they submit the application, they will receive EUA almost immediately.
For example, (these are my thoughts) the customer would want to have a product that has a very high level of accuracy, lets say 98%+ unlike most Covid rapid tests that are not very reliable at all. Who knows what additional studies the FDA would need for the above ?
We do know that any delays have nothing to do with the micro fluidic sensors from Sensera.
When they make the submission, they will submit with EVERYTHING that the FDA has asked them for.
As Ralph said, this should all happen shortly.
The above is MY ASSESSMENT of the situation.
SE1 Price at posting:
9.2¢ Sentiment: Buy Disclosure: Held
