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retinadoc

08/05/22 5:08 AM

#385284 RE: Whalatane #385277

ALZ's studies are among the most fraught in all of biotech. The trash heap of failed drugs is huge and any "success" will be dissected endlessly. Kiwi is correct that the best conclusion will be further study needed. These trials are incredibly difficult, ask Biogen. Focus on CV, that indication is big enough if the company can actually execute.

Birdbrain Ideas

08/05/22 1:47 PM

#385313 RE: Whalatane #385277

Thanks for your sobering and accurate post. As I think I've said in more distant posts, BRAVE is limited to 150 participants, thus only about 75 are taking Vascepa. And this language is contained in the description of the trial on ClinicalTrials.gov: "The overarching goal of this trial is to assess whether icosapent ethyl beneficially affects intermediate physiological measures associated with onset of AD in order to evaluate whether larger, multi-site, longer-duration Alzheimer's prevention trials are warranted to assess more definitive clinical outcomes."

So you're right in the sense that 150-participant trials don't normally give a company a big boost, even when they produce successful results. However, Alzheimer's is a different animal because almost nothing has been proven, even in a preliminary trial, to show promise for delaying its onset. I think a successful result would do several things: First, it would open the eyes of a lot of doctors who have been hesitant to prescribe Vascepa even for the purposes for which it is already approved. Second, there is such desperation in the Alzheimer's-affected community that a lot of people would begin using it on the mere chance that it might help, especially since a lot of that population is the same group of people who already qualify for insurance coverage of Vascepa because of heart-related and diabetes-related issues and because Vascepa has a safety profile akin to aspirin. And it helps that the woman leading the study is chair of the most influential government body advising on Alzheimer's. If she can't get funding for an immediate large-scale study, who can? And finally, BP is more likely to take a chance on Amarin as a potential golden ticket in the Alzheimer's space.