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Too much of a risk for Alzheimers Drug

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Agreed with above comments. They are doing studies and you need a pet scan, ok pet scan are only reimbursed for clinical trials. They are hoping the IDEAs 2 trial will change payout landscape. If not that Medicare patient will have to pay out of pocket for multiple pet scans bc of aria. Dr will need to pick a patient that lives with someone for monitoring and socialization. If Covid around still physicians will not want to put patients on infusion and put pts at risk. Good luck.
 




If FDA accepts drug for review and it's approved there are no guarantees that the drug will sell or payers will reimburse without making providers and patients jump through multiple hoops. Time will tell. And Biogen has a history of patience when new products don't get out of the gates fast. Good luck to all
 




anonymous said:
If FDA accepts drug for review and it's approved there are no guarantees that the drug will sell or payers will reimburse without making providers and patients jump through multiple hoops. Time will tell. And Biogen has a history of patience when new products don't get out of the gates fast. Good luck to all
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As it has been mentioned before, who between the ages of 50-65 is going to #1) admit to having exhibited and self-realized consistent cognitive slowdown (no one under 80 ever admits to this)
#2) Agree to get themselves tested for signs of early Alzheimer’s at that young of an age to then find out they’re doomed to a debilitating mental disease
#3) so they can take a drug that may only work slightly on a very very small subset of patients that the company cannot clearly define, outside of marketing it as “give it a shot, you might be one of the lucky ones”

I hope this works and there is something there, but If it was clear and evident, this would have been put out there already
 
























Everything I’ve read is there is a small chance it gets approved late 2020 or early 2021. There is also a small chance it’s gets a straight up denial. Most likely scenario is FDA asks for more studies and approval happens early 2023
 




anonymous said:
Everything I’ve read is there is a small chance it gets approved late 2020 or early 2021. There is also a small chance it’s gets a straight up denial. Most likely scenario is FDA asks for more studies and approval happens early 2023
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I don’t think that you understand the politics involved. First of all, it was granted Fast Track with a rolling review, which means increased contact with the FDA as they have submitted the pieces which gives them a much better idea about the likelihood of approval. Secondly, the Alzheimer’s Association and their lobbyists are behind this approval, and if you have sold in the market before, you know that they have some serious leverage (they were the main reason that Namenda got covered by Part D so quickly). Look for the quotes from their chief science officer. Like the cancer community, they will take any glimmer of hope that they can find. Thirdly, Trump’s agenda included pushing the FDA to approve medications for serious, life-threatening diseases much faster, which it has been doing and with less concrete data. Who is Trump’s target audience? The old folks. No doubt that he would love to take credit for getting the first disease modifying AD drug approved quickly (not that he deserves it).

I am not saying that I agree or disagree with any part of the politics, but it doesn’t change the fact that they exist.
 








anonymous said:
In all likely hood the new sales force will not have the product in their bags for at least 6 months.
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Was just informed by somebody in the know that discussions are now underway for type and length of additional studies needed for approval. It is now almost a certainty that 2022 will be the earliest this drug is launched.
 




anonymous said:
Was just informed by somebody in the know that discussions are now underway for type and length of additional studies needed for approval. It is now almost a certainty that 2022 will be the earliest this drug is launched.
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If we go by Cafe Pharma’s track record for posts like this, then I like our chances.
 




















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