Some points:
The NDA submission has now been combined to include cure and prevention whereas the earlier submission was just the cure (the "Lazarus" BV Phase 3 trial). So it is actually the major part (all of the medical and safety parts) of two submissions. The packaging and commercial aspects will obviously be handled in conjunction with the distribution partner.
These submissions are enormous.
Most "announcements" other than those referring to SPL internal research programs involve counter-parties and it takes two (or more) to tango, as the saying goes. The company might express its view of a timescale but the others will often have a different view.
While SPL will, I am fairly sure, have some budget targets for Fleurstat, I doubt these will be made public at the AGM. They will be included in the agreements between SPL and Aspen but I doubt we will be informed and I think this is right. SPL is aware of market research and Phase 3 participant feedback but that is a long way short of making revenue projections to shareholders.
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Some points: The NDA submission has now been combined to include...
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