The longer study doesn’t make sense to me without a change to endpoints. The study doesn’t need to be extended to measure pain reduction?
The only justification I can see is that the company has been given the heads up of what the upcoming FDA recommendations are and that the goal posts have been moved significantly.
I am sceptical that a) they have been given that information b) it would be let slip this way and c) that the FDA would need such a long study.
I’m keeping an open mind until we hear confirmation.
Ann: Paradigm to Present at Evercore ISI HealthCONx Conference, page-102
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