fda, page-2

Good comments but not quite correct, as I'm sure others more qualified than me will point that out.

Simply

It is not a case of one being more accurate than another, it's a case of doing what it is supposed to do.

To prove that fact they were advised by the FDA that they could compare it with other tests as no such saliva test could be used as a comparison.

It turned out they were given 'bum' advice and as a result they will need to furnish more studies on the effectiveness of oraline.

The data is available but before they put the next step into place the company and the FDA reviewers will have to agree on what is required. This time I would make sure they get it in writing so as there is no confustion.

I feel sure the company is on to it already and in the meantime it is business as usual for them. The next company update (whenever that will be?) should outline the next steps and hopefully some time lines. I think they should also advise the importance of FDA clearance and as I have always said it will be a nice to have but it is not a company maker.

cheers