Information27 Sep 2020 09:10
Again doing a bit of searching and came across 2 reports which are not technical but give the current situation in simple terms. I would think that before the submission Avion would have had meetings with the FDA so when it went in there were no surprises. For me the approval seems to be a rubber stamp job the only questions are about the conditions the FDA will put on it
from sharecast.com:-
The AIM-traded firm said its licensing partner, Avion Pharmaceuticals, has submitted a special protocol assessment request to the US Food and Drug Administration (FDA).
It said the special protocol assessment process would see sponsors reach an agreement with the FDA on the design and size of clinical trials, so that they adequately address scientific and regulatory requirements for a study that could support marketing approval.
from IMM web site
Strong regulatory position
Lupuzor™ received Fast-Track designation from the US Food and Drug Administration (FDA), which expedites the drug’s approval process by shortening review periods. Lupuzor™ also received FDA approval to complete Phase III trial under Special Protocol Assessment (SPA) which effectively guarantees that the regulator will accept the trials’ results if they are positive.