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rosemountbomber

04/14/22 7:01 PM

#374894 RE: Number sleven #374892

Sleven, I was thinking about the "FDA did recently lower the bar for Alzheimer's disease approvals" and this came to mind.

Medicare is a few days ago announced that it will only cover Aduhelm in clinical trials. So it may not be so easy for Vascepa to get covered (other than the fact that it is a ton less expensive than Aduhelm) if Medicare using similar guideposts. And, of course, we know the insurance companies will resist as much as they can and do.

So an easy access to approval might not be as valuable as hoped. But better to have successful data and then worry about the rest.
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ziploc_1

04/14/22 7:17 PM

#374896 RE: Number sleven #374892

Nsleven...Thank you for the essential info for the 'BRAVE study' on Alzheimers disease
Sponsor is VA office of R and D and collaborator is University of Wisconsin medical school...

Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Icosapent Ethyl on Alzheimers Disease Biomarkers in Preclinical Adults
Actual Study Start Date : June 8, 2017
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023