Ann: Pre-Submission package lodged with the US FDA, page-11

Well at least its finally submitted. I have to say I find the lack of progress or urgency to be very annoying.

I have to say that Covid19 was the perfect storm for RAP really...there is hardly anyone sick, no urgency required to approve this or anyone's submissions and the FDA and other health bodies have downed tools on anything not Covid19 related.

Health bodies are also not going to buy into anything non Covid because they won't have the money.

ClusterF@#$%^ for the company....and not really its fault....just bad luck.