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We are seeing more ARIA

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anonymous

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ARIA is rearing it's ugly head everywhere now that patients have been on the drug for 6 months. I am seeing a lot of it in my territory. This certainly has to affect how CMS will treat this drug. The published studies did not show additional reduction in cognitive decline, so who cares if it reduces amyloid? They were not able to demonstrate any reason to be on this drug. CMS is concerned about safety. This can only be played out in a clinical trial.
 




Thats why CMS will do the right thing and demand a clinical trial. Let us not forget that there is also a congressional investigation going on right now lookin at the Biogen/FDA dealings and FDA's B. Dunn. So many things in question and CMS has to know that is going on. Will CMS be impressed by the published studies? Of course not.
 








anonymous said:
ARIA is rearing it's ugly head everywhere now that patients have been on the drug for 6 months. I am seeing a lot of it in my territory. This certainly has to affect how CMS will treat this drug. The published studies did not show additional reduction in cognitive decline, so who cares if it reduces amyloid? They were not able to demonstrate any reason to be on this drug. CMS is concerned about safety. This can only be played out in a clinical trial.
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ARIA is a class wide problem with a-Beta antibodies. They all have ARIA-E/H.
 
























anonymous said:
The fact that Eli Lilly, Roche, Eisai, AbbVie, et al are doubling down on a-beta antibodies and using ARIA as a differentiator...shows that no one is leaving this modality for some time.
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Well of course not. Like Biogen, they all invested Billions.....but they are barking down the wrong tree. The amyloid hypothesis simply isn't the answer and it is sad they all continue to go in that directions like many of the other compounds prior to Aduhelm. Very, very sad. CMS will tell Biogen that the clinical trial stands. They need to do this now as the studies are sub-par. The whole world knows this. The FDA is being heavily scrutinized for jumping the gun and more information about this will be revealed soon. In the end, this compound deserves the scrutiny and if they are unwilling to move forward with the clinical trial, speaks volumes that they really deep down know that the efficacy just isn't there and hasn't been there.
 




anonymous said:
ARIA is rearing it's ugly head everywhere now that patients have been on the drug for 6 months. I am seeing a lot of it in my territory. This certainly has to affect how CMS will treat this drug. The published studies did not show additional reduction in cognitive decline, so who cares if it reduces amyloid? They were not able to demonstrate any reason to be on this drug. CMS is concerned about safety. This can only be played out in a clinical trial.
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You must be the same person who keeps posting about ARIA. Dude, we knew it would happen in almost half of the patients. You act like this is some kind of uncovered hidden mystery. The one study did show slowing of decline. If you are a TBM, then my question is how did you get away with being so clueless for this long? CMS isn’t primarily concerned about safety. They have made it very clear that its about clinical benefit.
 




anonymous said:
You must be the same person who keeps posting about ARIA. Dude, we knew it would happen in almost half of the patients. You act like this is some kind of uncovered hidden mystery. The one study did show slowing of decline. If you are a TBM, then my question is how did you get away with being so clueless for this long? CMS isn’t primarily concerned about safety. They have made it very clear that its about clinical benefit.
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There is no clinical benefit. Next question..
 
















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