"ImaScientist Thanks for your comprehensive response.Yes again I...

"ImaScientist Thanks for your comprehensive response.

Yes again I am in agreeance with you.

I think it is probable that the FDA will provide two incongruous but simultaneous pathways:

1: they will allow the use of Rem-L in COVID patients via some form of approval given we are in a Pandemic;

2: simultaneously, they will want the trial to continue (probably in a less 'gold standard' format) to provide further evidence on all levels.

One final left-field thought: is it possible that they might approve REM-L for pandemic COVID-19 use, but demand a separate non-COVID ARDS Phase 2/3 trial for the use of REM-L in a new separate RCT so as to parallel REM-L effects on COVID ARDS. And the results of this new Phase 2/3 would inform the FDA on non-COVID ARDS label extensions? ....

This way they emphatically support trying to tackle COVID-19 while still obtaining gold standard REM-L data?

Thoughts anyone?