I am expecting ph3 results to be better than p2b given OPT has ‘enriched’ aka juiced the trial to deliver a positive outcome.
Opthea has also been able to gain agreement from US and European regulators to enrich its patient population. This means that the primary analysis will be in patients with two particular forms of wet AMD, minimally classic and occult, which represents between 65%-80% of the market according to the company. There was greater benefit seen in these patient subgroups in the Phase IIb trial, with a mean 5.7 letter benefit.Across all lesions the benefit over the control was 3.4 letters, which was statistically significant. (The company has also excluded RAP lesions, which delivered a 4.4 letter benefit overall in the Phase II study.) Presumably if clear benefit is shown across all patients, then the company will be able to include all patient populations in its marketing label (excluding RAP lesions).Does anyone feel that ph3 results will be overall better than ph2b as they have excluded RAP cohort which performed significantly worse than the others in the trial?
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