Looks like they are preparing for both possibilites,..
Manufacturing plans for drug substance appropriate for late phase testing and eventual market introduction are also underway.
I think Leo is telling us that a deal is about to be finalized (just after secondary trial results announced) and that they are already preparing all things for the future advancemnt of B-OM.
Looks like they are shooting for some sort of early FDA approval, probably based on the B-OM preventative properties.
"The next steps will be aimed at defining the most appropriate development plan to complete its evaluation prior to submission for marketing approval. This will involve consultation with the FDA and other health authorities worldwide, once full efficacy and safety endpoint data are available from the recent clinical trial".