Paul Rennie interviewed on Marcus Today Podcast., page-12

My gut feel is that this could all hinge on compelling 6-month 008 data. In two parts...

1. Pain and Function. I believe we already have enough compelling data for Pain and Function that a reasonable person would expect us to meed the endpoints for Phase III - which are set at around the 8-week mark. If the 6-month data is compelling enough to show duration / separation from placebo at 6 months....I think that would really excite the potential suitors.

2. DMOAD. If the 6-month 008 data on biomarkers and structure is also compelling, and enough that Donna, Paul et al can go to the FDA/EMA and thrash out an achievable pathway to AA for Zilosul....

....I think we could finally be off the leash for an OA deal.

That's because:

a) There is increased certainty of passing Phase III

b) There is an achievable pathway to AA and DMOAD

c) a Deal will take time to finalise - no matter if we've been speaking with an organisations delegates already up to this point. If we get a realistic achievable pathway to AA after discussions with the Agencies, then the clock is already ticking. We can't waste time. We need a deal because we need to be able to hit the ground running as soon as we get a label, and if that is via AA it'll require pre-planning. It could become problematic if we are granted approval and don't have a deal in place - because the 3-year regulatory exclusivity clock starts ticking, the 25-year supply exclusivity clock starts ticking, and competition starts to mobilise.

I think we will be in a position at that point (pending all the things above happening) to strike a deal PENDING approval. Striking a deal pending approval does two things. It takes the risk off PAR because we have added certainty, and the doubt about approval is not baked into the deal we accept (so we leave nothing on the table); and it takes the risk off our partner who will therefore be able to offer the highest possible terms, knowing that there is no trial risk baked into their numbers.

Just my thought process. I don't know anything.