Lucira Health Inc (fka LHDXQ)

[BeamMeUpScotty]

Because as already stated by the company the FDA approval process is long winded and tortuous to say the least.

What they’re saying is that they expected to get approval about six months ago.

It is my understanding that the FDA doesn’t have a bank of in house experts that can just sit down confer and generally bang heads together. I believe that it’s more like they will find experts in whichever field it is that the application covers and get them to sign up to review the application.

Then I believe they get the relevant team to start reviewing the data, the review team asks questions, the questions are passed back to the company at strategic review points then the company is given time to answer then the reply is passed back to the review team etc etc etc ad nauseam!

You can see why it takes forever for the FDA to complete one review!

Saying all that the FDA has its place. The FDA reviewer who refused to give Thalidomide a final license in the USA was acknowledged with an award at a national ceremony.