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Re: Investor2014 post# 496166

Monday, 08/04/2025 2:58:13 PM

Monday, August 04, 2025 2:58:13 PM

Post# of 517269
Here's the thing: the "E" in OLE stands for extension. It's extra info that helps track long-term safety and efficacy -- for instance, does it cause cancer or does it lose effectiveness after a few years if people build up a tolerance? The dropouts that happened after the trial ended will provide useful information but that's not going to be the priority for the EMA review team. They're going to look at the data results while the trial was ongoing first and foremost, and that data is pretty solid. The OLE data from those who didn't drop out is also very solid. They'll add up those two factors to make a decision.

This could very well be approved under the guise of 'it's safe, appears to work well for a lot of people, but it's up to you if you can handle the dizziness."
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