RE: Phase 3 Trial16 Oct 2020 11:20
I know I just mentioned Clinigen with regard to the Phase 3 trial, but as we now know Synairgen will be using Parexel Biotech (ranked first among global CROs in 2019) to manage and run the trial. If you have 900 patient in the trial split between 20 countries that's only 45 total and not all will be on SNG001. Once they start administering, as has been said, beneficial results will be seen quickly (2 weeks max)...so my thinking is, if the doctors/consultants in these locations suddenly realise they've got a winner on their hands and they would like to start using SNG001, is that where Clinigen then could come in...'don't worry chaps, the cavalry is here. it's not regulated yet but we can offer it for you on a compassionate usage basis'...
So why 20 countries???
1. Speed of trial followed by possible immediate access to the marketplace pre-regulatory approval.
2. Wide cross-section of ethnic/cultural groups to better prove it's safe and works regardless.
When they pull this off chaps it will be a blinder...