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Re: mcbio post# 193722

Saturday, 07/25/2015 12:15:49 PM

Saturday, July 25, 2015 12:15:49 PM

Post# of 257442

ESPR—If it is truly a broader label for [Praluent], shouldn't that be viewed as a positive for ESPR in that it may be more likely that an outcomes trial won't be required before full approval?

You need to specify whether you’re talking about Praluent’s FDA label or its EMA label, which are widely different (despite the convoluted attempt by some ESPR longs to claim that they are similar).

In any case, I don’t agree with the notion that FDA/EMA approval of Praluent and Repatha before CVOTs generate data guarantees that ETC-1002 will get the same treatment.

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