yes, completely agree. Well done to you in checking the FDA site directly. I had forgotten to do that.
I believe for worse hotspots like USA, Sth America, India, Africa etc, the gov focus is shifting/has shifted to getting faster testing processes and results setup (respiratory, saliva, blood) as they can't hope to identify and control their enormous spread using std border control/talk/contact trace methods.
I believe Access Bio (Atomo) + NG Biotech test devices have a v good chance of getting approved in almost all the countries they are chasing and opening up the market for many many months/years of product supply.
Not to forget, a big side benefit (if one can call it that in a pandemic!) is Atomo's bread n butter sales & company growth comes from HIV, fertility and other infectious disease testing..which was already a growth market. There has been a marked reduction in testing resources/lab availability for a variety of other infectious diseases, with the strong global resource & lab focus on Covid19 tests. There are other cororavirus' also out there too that need to be tested for (though much lower infection/mortality rate).
All above = growing need for rapid, low cost, reliable test methods requiring minimum infection protocols and risk.
All this market +manufacturing exposure for Atomo for Covid19 will allow them to market themselves across quite a broad segment and enable more testing partnerships/sales. John Kelly has already said several times that board's goal is to grow into a global company (like Resmed, Cochlear, Nansonics etc) and not just focus on short term only. I am content to wait for them to continue kicking these goals as planned and reach $1-$3-$6-$12 growth over time.
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