Firstly, we can confirm that the FDA is back at work & not on...

Firstly, we can confirm that the FDA is back at work & not on Summer ! vacation as in Australia as per follow link.
Scroll down where you will see a number of releases in the last 2 days
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas

Secondly, assuming the customer is NanoDx, the delay in submission to the FDA is as previously posted here by Vetrani due to the various modalities.
https://testingmethods.crowdicity.com/post/3232360
Look at this latest post from Stewart Mackie from the U.K.

Hi PatrickI did get an update from the manufacturer - I had expressed the same concern about the delay. It comes down to the decision taken by the manufacturer to submit data for all three modalities: nasopharyngeal / blood / saliva. Whilst this a more comprehensive pathway, it does mean that it takes them longer to collect the data, hence the delay. I've been assured they expect to complete the data validation within the next couple of weeks and they have been in constant dialogue with the FDA, who have already assigned the product as breakthrough technology, and the FDA will not take long to issue the EUA after the data are submitted. The delay is the collection of the data for the 3 modalities.I too had a concern that there was a fundamental issue somewhere with the product and that was what was causing the delay, but I am assured it purely down the data collection, which was possibly the right decision from a scientific perspective but possibly not from a commercial one.I will absolutely let you know when the EUA is issued.Many thanks for your patience, but I think NanoDX know they have a revolutionary product and want to ensure all the i's are dotted and t's crossed for the FDA.Best regardsStewart

I would anticipate submission to the FDA and granting of EUA prior to the Dec quarterly.
Hopefully, some of the nervous long term holders that have started to become nervous about things & I even know some of them have lightened their positions will be able to RELAX now. We are in the HOME STRAIT !

Hopefully, the share price will firm up to a more realistic price of 14-15c prior to granting of EUA.