Post by
dart321 on Oct 28, 2021 10:09am
Normal for the FDA
When they are unable to duplicate trial results in their own labs the always give a company one last chance with a quick short field trial. Good luck all I think you are going to need it.
Comment by
dmshediac on Oct 28, 2021 10:26am
This post has been removed in accordance with Community Policy
Comment by
hemi3tc on Oct 28, 2021 1:28pm
then why do many companies fail with such great results? thosr days of the FDA blindly accepting data is long gone since the days many bad tests got through.
Comment by
Yamaha on Oct 28, 2021 10:31am
Your post couldn't be more wrong It's a short performance test not a clinical study test, the FDA aren't questioning the test results, but want to know real life ease of use of test, this will be done quickly. One last tiny hurdle and it's off to the races... Very positive NR that most mis-read or don't understand?
Comment by
1518midas on Oct 28, 2021 10:36am
Agreed! People are tired of waiting and are overreacting. This is a gift!