That's right. Unless any new results are remarkable, the phase 2A and 2B studies both raise questions that I think the FDA will want addressed i.e. why does the 0.07 dose work but not the 0.15 dose etc.
LOR also does not appear to act as a DMOAD, since no significant difference in medial joint space width was observed between between LOR and PBO groups after 18 months of follow up.
I also wonder whether the FDA would request confirmatory trials to be conducted by an independent CRO.
I'm not convinced the current set of trials are enough to receive registration for LOR, unlike for PAR, since PAR's set of clinical trials are a lot more comprehensive.
Biosplice are taking quite the gamble looking at NRS pain reduction at 12 weeks as their primary endpoint in the P3 trials.
That's right. Unless any new results are remarkable, the phase...
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