Wouldn't be setting expectations on near term on either AA or...

Wouldn't be setting expectations on near term on either AA or DMOAD.

Defining what is required for DMOAD is still an undefined scientific framework so FDA will need to work through carefully.

OA pain a function is P3 primary end points for NDA. This will be sufficient given the following key facts on OA:

Key facts

In 2019, about 528 million people worldwide were living with osteoarthritis; an increase of 113% since 1990 (1).

About 73% of people living with osteoarthritis are older than 55 years, and 60% are female (1).

With a prevalence of 365 million, the knee is the most frequently affected joint, followed by the hip and the hand (2).

344 million people living with osteoarthritis experience severity levels (moderate or severe) that could benefit from rehabilitation (3).

With ageing populations and increasing rates of obesity and injury, the prevalence of osteoarthritis is expected to continue to increase globally.

Osteoarthritis is not an evitable consequence of ageing.

Reference: Osteoarthritis (who.int)