fantom, all good points and questions. I have emailed about this very subject. Although Dr. Chan has responded to my email, he is not able to provide an answer to these questions.
I agree...it was March or April when we got the designation. I think the delay is ridiculous...even with COVID still active. Dr. Chan mentioned in a previous PR that we would know very soon. That was a couple of weeks ago. It is very frustrating to watch the paint dry on the wall.
What the hell is the status of the FDA approval? Do we need a trial, as most think, or don't we? The answer to this question is material news. The fact that we don't know leads me to believe that they don't know. 6 months! Pick up the phone.