So, just thinking through what has to be done: 1. Attend the...

So, just thinking through what has to be done:

1. Attend the SAWP workshops and define the trial
2. Recruit enough suitable patients for the trial
3. Produce new product for the trial
4. Conduct the trial - say, 12 weeks of work?
5. Do the analysis and have the data approved by SAWP.

I guess, they are going to have to do it anyway for the FDA approval but this is going to require

a. Time
b. More Money

So 12 months is a conservative delay I think.

This is all just back of the napkin stuff for me, I welcome expert input.