Celebration Thread! Biogen is going to the FDA with Aducan.

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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Mon Jul 12, 2021 8:19 pm

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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Mon Jul 12, 2021 8:26 pm

We haven't explored much of the safety results from the pdfs. Above Tables are from the Med pdf from the recent FDA document release ~pdf page 164. The homozygotes have substantial ARIA-E at 10 mg/kg -- upwards of 64%. For some reason 44s have especially high relative risk (to the 34s) for ARIA-H.

The pdf then goes on to provide 29 patient narratives of their ARIA experiences.

First patient MCI 44 ARIA-E after 4th dose (1-1-3-3). Somewhat surprising that some of these patients developed ARIA even with 3 mg/kg dosing. If patients could be pre-titrated before (perhaps years before MCI onset much of the ARIA would be avoided. This would be particularly beneficial for the 44s.

Another MCI 34 ARIA after 4th dose; used plasmapheresis apparently with some success. Will be interesting to watch as different treatments are explored.

Another MCI patient ARIA after 5th dose. What caught my attention here was the patient was found on the floor on day 130 -- 3 days after the last known normal state. That is startling to me. Is there really no electronic monitoring offered to patients in the trials? Even something as simple as an electronic call-in/internet contact 3 times per day would make a great deal of sense. Very difficult to understand how there could be almost no monitoring-- could even be something passive such as a GPS watch etc..

Another MCI after 4th dose of 3 mg/kg followed by ARIA.

I went through all 29 of these accounts. What I find of interest is that the Mild AD patients appear to be somewhat underrepresented. 80% of the patients enrolled were MCI, so we expect that 23 of 29 would be MCI. Yet, in fact, it was 26 of 29 (~90%). One of the three Mild ARIA patients actually had an ARIA event during the placebo stage and then went on to have an ARIA event during the titration stage (after the 4th injection) of the long term extension-- and then had another ARIA event after the 5th injection. It would probably make a great deal of sense to have a slower titration schedule for any patient with history of ARIA. It will be very interesting to see whether they find that there is less ARIA in those with Mild AD.

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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Tue Jul 13, 2021 7:39 pm

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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Tue Jul 13, 2021 7:47 pm

This is another exciting figure from the recent FDA Medical report for aducan. The figure shows the occurrence of ARIA by the number of Aducan doses. What is of particular interest is the column on the right: the 29 patients who experienced serious ARIA. For me the fact that these serious ARIA events occurred so early in treatment is somewhat unexpected. In fact, 24 (0+ 1+ 2+ 11+6+ 4=24; 1-1-3-3-6-6 (assuming high dose)) of these 29 patients would not have yet received a 10 mg/kg dose during this titration phase.

11 patients had a serious response after the 4th dose which for patients on the dosing plan should be 3 mg/kg? This is a surprise. It would be of clearly significant importance to attempt to find some predictive (not sure whether I should say it) BIOMARKER that could screen out these patients. Perhaps these patients have significant CAA illness? 2 of the 29 patients had a serious ARIA on their first 10 mg/kg and only 5 of 29 on any 10 mg/kg dose?

The med report also later reports on a patient from the 104 study who had a single 3 mg/kg dose which caused severe side effects including unresolved severe dementia. The titration dosing schedule makes a large difference to the side effects that patients will experience. Hopefully, additional research will be conducted to optimize titration. As a basic observation, it seems that tripling the dose from 1 mg/kg to 3 mg/kg is too much too fast of a ramp up. The first and second dose at 1 mg/kg is generally quite well tolerated; only 1 patient of the 29 serious ARIA patients had a serious response to 1 mg/kg. Yet, there were 11 patients who had serious ARIA after the second 3 mg/kg dose. Adding a few extra months of titration possibly could help avoid some of these side effects, though it is entirely possible that there is a counter-intuitive logic at play.

I hope that patients will be actively involved in the decision making process related to titration. 26 of the 29 serious ARIA patients reported had MCI, so they were quite highly functioning before they experienced ARIA; for some it might be a tough call because they feel the time pressure of advancing dementia, though it still might be advisable to go somewhat slower on up titration. There is a wave of approaching anti-dementing drugs that could help at a wide range of impairment levels. Less of a sense of urgency would seem reasonable.

It also has me thinking that possibly an anti- anti-amyloid antibody strategy might be possible. Give the antibodies some decoy amyloid to lock down onto to clear them from the blood stream if a patient develops serious side effects. This strategy might be behind the plasmapheresis treatment noted above that a serious ARIA patient received. It's always reassuring if an antidote can be on hand when things don't go to plan.

Lots of great research to look forward to in addressing ARIA and other issues. Wonder what influence genetics (aside from APOE) might be involved in the serious ARIA incidents?

[The idea that the Mild patients might have lower serious side effect risk does not appear to be true. After the 29 "serious" ARIA patients were described other patients with additional serious responses were described which seemed to balance out the proportion of mild AD patients to around 20% (as expected).]

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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Thu Jul 15, 2021 9:03 pm

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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Thu Jul 15, 2021 9:21 pm

One of the recurring questions about the aducanumab clinical trials was: Which high dose trial was correct 301 or 302? You can't simply discard the trial that does not fit your own particular vision of reality; we cannot choose whichever objective reality we prefer the best-- reality is a given that we must adjust to. As I noted recently the fact that the 301 high dose is unable to align (even slightly) with the 301 low dose offers a strong clue, while the 302 high, low and placebo doses form a nearly perfectly straight line with almost the exactly expected regression slope.

The above figure highlights another aspect of the unalignment of 301. Which of the studies was the most stable from the interim to the final analysis? Which the most unstable? Presumably the trials that were the least changed had found their balance; they had found their equilibrium. They were stationary.

Interestingly, the 301 low dose was the most stable of all the trials. It barely budged from the interim to the final analysis 3 months later. Perhaps this should be expected for a low dose as the dosages did not change mid-way through the trial. The next most stable was the 302 high dose. It changed from -18% to -22% change on CDR-sb (moving from -0.28 to -0.39). [For some reason, -.28 to -.39 is not proportional to 18% --> 22%]. At least the percentage change was fairly stable and this is similar to other modern anti-amyloid results. 20-25% reduction in decline on CDR-sb has been replicated a few times now.

The biggest mover (the most unstable) was the 301 high dose. It changed from +15% to +2% over these 3 months (CDR-sb changed from +0.22 to +0.03). CDR-sb for the 301 high dose changed by 0.19 in 3 months? This was the largest change of all the trials. It is remarkable how rapidly the 301 high dose was equilibriumizing. Importantly, it was the one equilibriumizing to the 302 high dose and not vice versa. The green arrows are not fit to the scale of the graph, though are proportional to the CDR-sb changes. The 301 high dose was the most aberrant of the recent high dose anti-amyloid results and from the interim to the final analysis it appears to be in a hurry to get on side.

Of note, all of these aducan trials improved from the interim to the final reading. That seems unusual. Shouldn't the interim readout be an unbiased estimate of aducan's efficacy? Then why did they all show improved cognitive performance through time. Could we project this trend forward another 3 months and expect 302 high at -0.50 and 301 high at -0.16? How did these changes evolve through earlier time frames? One could expect that as patients with more aducan doses completed that they would have experienced greater cognitive benefits.

Another notable finding from the FDA Briefing Document that has not been highlighted as of yet is the 302 high dose result excluding post-ARIA observations. Apparently after experiencing ARIA many of the patients continued to be assessed. Yet, as
I could understand with the reports about the consequences of serious ARIA, there can be substantial lingering impairments through time while recovering from ARIA. Many of the patients experienced some level of ARIA including ~60% of high dose 44s. What happens to the CDR-sb if post-ARIA results are removed? FDA Briefing Document pdf page 232 CDR-sb -0.57 (n=172 from n=299; 33% reduced decline from 22% reduced decline for all patients). {Somewhat surprisingly for the low dose arms the ARIA adjustments actually reduced the aducan benefit.). -0.57 CDR-sb is quite a bit larger than the reported -0.39 that we have referred to. Of further interest is that there was also some mention that those who seemed to gain the most benefit from aducan had some level of ARIA - could removing amyloid robustly actually help AD patients? Yet, over the longer term we also saw that achieving amyloid negativity appeared to help prevent later large declines in cognitive functioning.

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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby lumia » Thu Aug 05, 2021 11:14 am

Stat News: Federal watchdog will review the controversial FDA approval of Biogen’s Alzheimer’s drug

the process used by the Food and Drug Administration to approve the Alzheimer’s drug sold by Biogen, which has caused unprecedented controversy over regulatory standards.

Specifically, the HHS Office of Inspector General will examine the accelerated approval pathway that the FDA increasingly uses to speed approvals for medicines to treat serious conditions and fill an unmet medical need. This was the pathway used by the agency two months ago when it OK’d the Aduhelm treatment for Alzheimer’s.

However, the agency endorsement is arguably the most controversial approval it has ever made and is generating intense scrutiny because of the circuitous path that Biogen took to convince FDA officials to greenlight the medicine. Consequently, acting FDA Commissioner Janet Woodcock asked the OIG to review the approval process. A consumer advocacy group made the same request.

Those requests followed a STAT report that Biogen launched a behind-the-scenes effort dubbed Project Onyx to convince FDA officials to approve its drug. The drug maker took this step in light of a complicated and confusing reanalysis of two clinical trials that initially cast doubt on Aduhelm’s efficacy.

Instead, the company reanalyzed the data and found that participants receiving the highest dose of the drug in one trial experienced a very modest slowing of cognitive decline, but participants in the other trial did not benefit at all. With potentially billions of dollars in sales at stake, Biogen targeted Billy Dunn, who heads the division that approved the drug and, therefore, was seen as a needed ally.

Consequently, the FDA played a proactive role in helping the company navigate the process, going so as far as drafting a road map on how the company could win approval. The disclosure, which experts have described as unusual, triggered outrage, especially after an FDA advisory panel of outside experts nearly unanimously recommended the drug not be approved at a meeting last fall.

Moreover, the panel was not told by the FDA that accelerated approval was an option being considered or that reducing amyloid, a protein in the brain that some believe slows memory and thinking, would be used as a surrogate marker for effectiveness. In fact, Dunn told the panel meeting last November that amyloid would not be used as a surrogate.

And so, the HHS OIG will review interactions between the FDA and “outside parties, as well as other aspects of the process, such as deciding on this pathway and scientific disputes,” the watchdog said. The review will extend to FDA policies and procedures, and determine whether the agency was in compliance by looking at a sample of drugs that were approved using the accelerated pathway. However, the OIG will not assess the “scientific appropriateness” of any of the drugs to be reviewed.

“We are committed to overseeing the integrity of FDA’s drug approval process, including the decisions informing how some drugs are selected for the accelerated approval pathway. Our planned work takes into consideration the concerns raised by stakeholders about FDA’s approval of the Alzheimer’s treatment drug Aduhelm,” an HHS OIG spokesperson said.

“As part of our comprehensive assessment, we will determine if the application of FDA’s pertinent policies and procedures allow for inappropriate relationships with pharmaceutical officials and other external entities. We are confident our findings and recommendations will provide meaningful information to stakeholders and promote optimal program administration at FDA.”

However, the report is not expected to be completed by 2023 and may be one of multiple reports HHS OIG issues as part of its review.

The approval has financial and health implications for millions of families, insurers, and American taxpayers. The wholesale list price is $56,000, greatly surpassing the $8,300 threshold that a nonprofit determined was the price at which the medication could be considered cost-effective. There are an estimated 5.3 million people 65 years and older in the U.S. with Alzheimer’s and another 200,000 younger patients with a milder form of the disease.

Initially, the FDA issued a broad label for the drug, meaning it could be prescribed to anyone, but the agency later narrowed that to people with mild cognitive disease or mild Alzheimer’s. But the debate over effectiveness prompted Medicare to schedule a meeting to decide national coverage and some private health insurers are either withholding coverage or waiting to see what Medicare will decide, leaving many people in limbo.

In a brief series of tweets on Wednesday, Woodcock wrote that the FDA intends to “fully cooperate” with the review and “welcomes the opportunity to provide clarity” on the accelerated pathway. “We are committed to ensuring the integrity of the accelerated approval program. … Should the HHS OIG identify an actionable items and provide the agency with any recommendations, the FDA would review those expeditiously to determine the best course of action.”

The FDA, however, has publicly defended its approach to approving Aduhelm. In a July 28 letter to the New England Journal of Medicine, Dunn and three other high-ranking officials at the FDA division that approves medicines argued that the accelerated pathway was appropriate and there is clinical evidence that the drug can benefit some patients.

“The decision fits squarely in the accelerated approval pathway, which was created to allow patients with a serious or life-threatening disease earlier access to a potentially important treatment. As scientific knowledge evolves, so should our thinking, and it should be reflected in our decisions. We believe current knowledge was appropriately reflected in aducanumab’s approval,” they wrote.

In a statement, Michael Carome, who heads Public Citizen Health Research Group, praised the decision by the OIG. The consumer group had urged the watchdog to review the approval over what Carome called a “collaboration that dangerously compromised the independence and objectivity of the agency’s review of the drug.”

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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Sat Sep 11, 2021 7:02 pm

Feeling great after a summer refresh!
Time to start banging on tables again and make this a better world.
(The success with aducan has only encouraged such behavior.)

All right, here it is.
I received my full genome scan a few months ago and there were a few shockers that were reported with the polygenic risk scores and help to explain features of my family experience.

As a teenager I developed severe hypertensive illness. Life was extraordinarily stressful for me which is to say my subjective evaluation of what might seem to be fairly mundane aspects of living: school -- family -- community created enormous subjective stress. To cope with this vast stress of teenage life I was prescribed valium, propranolol, anti-psychotics -- counseling ... . My high school days were profoundly stressful. How could this possibly be true? On the surface my life seemed quite average.

Family members seemed largely oblivious to my personal interpretations of a stress filled world. If anything they found it highly unlikely that such stress could be generated by the seemingly ho hum day to day existence of our life. Interestingly my subsequent experiences with online education have been completely devoid of these anxieties. Once entering into the online learning environment, the extreme stress that I had experienced vanished. There has not been any obvious need for a polypharmacy for me to cope with virtual reality.

Yet, other family members have also experienced in their own way with apparently similar subjective evaluations of stress, though their choice of self-medication has been more chronic drug and alcohol abuse. They have displayed a pattern of stress over-response that is highly consistent with my own behavioral repertoire. For example, recently some toast burnt because the toaster button had inadvertently been moved to the "well done" position; this caused a near mental health crisis. A leaking mini-fridge caused by a bent capillary tube was almost the end of the world. Other affected family members have engaged in verbal battles with unseen spirits which apparently is another manifestation of the response to this peculiar form of stress. Of course, the COVID vaccine has caused yet another stress crisis as the risks involved seem every bit as present as those from the Thalidomide tragedy. Family members have even refused urgent emergency medical care also apparently in some relation to the family stress condition.

The nature of the illness that has caused this unusual behavior has not been clear to me. A range of psychiatric/medical labels have been tossed around and this has caused some sense of shame and embarrassment and a reluctance to more openly discuss what has happened in the family. However, my full genome scan with polygenic scores appears to have found the somewhat unexpected cause. It is still somewhat preliminary and it might yet be somewhat complexified by additional genetic risk factors, though the primary driver of our families stress problem apparently was:

Post-traumatic stress disorder. My polygenic risk score for PTSD was well into the mid 90 percentiles-- about 7% of the population will experience PTSD, so the risk and the epidemiology match up.

A diagnosis of PTSD had never been on the table. I do not ever remember such a suggestion ever being made. The problem was presented more in the context of a straight mental health problem than an anxiety disorder. However as soon as I saw the genome report I knew that PTSD was the right diagnosis. The problems in our family are highly sporadic; when the toast burns there is an existential crisis and then there isn't until the toast burns again -- as soon as the stressor is removed the crisis resolves. In online academic environments, there is a flexibility in when assignments and testing can occur which largely eliminates the stress of learning. PTSD would seem to be the perfect fit for our experiences. It is the ultimate Dr. Jekyll and Mr. Hyde type illness -- the illness is only present under specific situations and then it can disappear. The response seems highly reproducible. Other psychiatric illness including schizophrenia and mood disorders should seemingly have a more persistent signature on neuroimaging and behavior.

Even still a PTSD diagnosis seems counter-intuitive: How can you have post-traumatic stress disorder when you have not experienced traumatic stress? This seems oxymoronic. I have lived a pleasant suburban life -- we wave at our neighbors they wave back-- it is scandoulous if we do not mow the lawn every week-- where's the trauma? Doctors probably steered clear from the PTSD diagnosis in such instances exactly because it might seem on the face to be ridiculous. The diagnosis could then simply be moved down the line and referred to as generalized anxiety disorder etc..

However, the polygenic score from the full genome score did report it as PTSD. This was near the top of any reported behavioral PGS. In my particular instance, what seems to have happened is that the PGS was so high that for me (and other family members) Life is a traumatic stress experience. With polygenic type traits the behavior typically would not be expected to run true through generations, however if there is substantial risk present on a single strand of a chromosome then you might then see multiple affected family members as we see in my family.

My impression is that PTSD has been probably underdiagnosed because of its association with traumatic experiences, while the life as a traumatic experience perspective has been neglected. The presentation in the Merck Manual illustrates how PTSD has been somewhat sidelined. Under Psychiatric Disorders there are ~10 main headings. PTSD is listed as a subheading under Anxiety/Neuroses. What I find of interest is that many of these other headings could be reconsidered as symptoms of PTSD. For example in our family experience drug dependence has largely been a symptom of the underlying PTSD. Many of the other headings could also blur into symptoms of PTSD.

It is important to get this diagnosis correct because there can be effective approaches to largely eliminate PTSD like behaviors. This has been clearly true in my personal experience. In a typical high school environment, I developed severe hypertensive illness, though in an online environment often with highly similar academic experiences (yet without social interactions) there was a near absence of PTSD like stress. There are possibly few pure psychiatric illnesses in which a cure is so highly dependent upon the environment. I would expect that manic-depressive or unipolar depression could so rapidly vanish merely by removing the stressors typically present in a physical environment.

These insights also pose a substantial challenge to medical legitimacy: If experts are unable to provide the correct answer, are they still experts? As can be seen above deducing the correct answer with PTSD like illness is of high relevance -- the right answer can allow for a functional cure to be achieved and with the rapid uptake of full genome sequencing, the right answer will now follow directly from the polygenic scores. The benefits that will accrue to the community for this one genetic condition could be substantial.
In a typical high school of 2,000 students perhaps 100 of the students (or more) might be silently struggling with unrecognized PTSD.
The decline of functioning at a school wide scale from the associated PTSD derived drug and alcohol abuse and other social pathology probably would be significant. Identifying these students early through genetic testing and then offering them alternative paths (such as online options, stress management instruction, etc.) could greatly improve their life outcomes and the well-being of the community.

I hope that this post is able to spark some change for those with PTSD like behavior and also initiate a conversation about how we could incorporate this new genetic knowledge to create healthier and safer communities for children and others.

We live in an internet connected world in which ideas can truly change the world. It is almost impossible for me to believe that this problem has existed right up to the present time and has largely went unrecognized. It is not so much that people are unaware of anxiety or PTSD, it is more that what I have posted about above did not cleanly fit into the correct category. It is only when you can enunciate the correct diagnosis of PTSD caused by high PGS that everything suddenly moves into focus. In my own experience no one in my community was able to figure this one out. It is startling! If you know what to look for PTSD like behavior can be recognized almost immediately. On a population scale, millions of people might have went unrecognized.

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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Wed Sep 29, 2021 6:29 pm

Everyone I think it is time to reactivate the thread!

Yeah! Yeah! Yeah!

It has been great to get away from all aducan all the time, though it appears that the cycle has now started up once again. Biogen has announced within the last few days that they will start a rolling submission of lecanemab. This is awesome!

I had not been totally sure when they would start this process; I mean they just got breakthrough status what in June?
Now it's September? And it's already to submit?
It is going to take a while until I get a handle on how all of the FDA processes work.
I thought breakthrough status was more of an honorific that might not have any practical significance for years!

Yet, here we are and leca is now in motion.
It might be about time to start up "Celebration Thread! Biogen is going to the FDA with Leca!"
I think that an extra exclamation mark is warranted as leca is a second generation anti-amyloid that is clearly superior to
Aducan. The ARIA rates for leca are substantially lower than Aducan; while the clinical outcomes appear somewhat better also than for Aducan.

I am very unclear why other online commentators seem to find it somehow objectionable that the flood gates of anti-amyloids have opened after the Aducan approval. For those who have family experience with dementing illness this would seem a blessing. If the water gets too high, then I guess we'll just have to swim. The next year will be the golden era of Alzheimer clinical medicine. There truly are a great number of anti-amyloids on the way that could help the tens of millions of those in need. Yeah! There could be a whole bunch of anti-amyloids in the regulatory cycle all at once. I am not sure how I'll be able to cope with it all. First world problem.

The FDA's decision to approve Aducan can now be seen as brilliant. I did not quite understand what was happening back in July, though in hindsight it is clear that Aducan's approval would inevitably encourage other anti-amyloids to file for breakthrough status and then file for approval. Clearly this is exactly what has occurred. These second generation treatments will reach the market sooner than they would have without Aducan's approval. This will be such a win for the community.

There have been so many people of high moral integrity working together on this that I suppose that it was all bound to work out for the best. I know I pulled as hard as I could for what I believed was right for the dementia community. Yet, there were a great many other stakeholders who also pulled with all their might and what we have arrived at is what I think is probably the optimal solution.
Aducan was approved, though the actual roll-out has been slow walked (really slow walked). There has been a great deal of resistance.

However, the lasting benefit of Aducan's approval is the acceleration of the next generation of anti-amyloids. Lecanemab and Donanemab and perhaps others now might reach the market years earlier than expected. Lecanemab could be ready for distribution exactly when Clarity ends. It would have been a year or more under ordinary circumstances. Aducan might soon be understood more as a transitional product before the arrival of lecanemab. In fact, it would not seem unreasonable that Aducan could at some point be withdrawn in favor of Leca, as these products have similar effects, while Leca has notably lower side effects.


Leca is an impressive product with quite low side effects. The timing to submit in late September suggests that the FDA could now move forward with the regulatory deliberation and when the final result for the Clarity phase 3 is posted give the final OK for product launch. The Clarity number should be essentially indisputable. From all of the back posts on this thread, we should have a very good idea of where the number should line up on the cognitive benefit versus amyloid removal grid. 800 patients all in a high mono-dose arm? This is going to be exciting! I will still want some wiggle room to work with (when you actually go through the process of constructing a framework to understand something (e.g., the correlations that appeared repeatedly on this thread regarding anti-amyloids you can have a concern that perhaps something might not line up as it should.) Yet, as noted earlier even the leca phase 2 lined up remarkably well once isodose treatment arms were combined to remove data noise), though the phase 3 leca result could be another bullseye. We'll have to wait impatiently to see what happens.

One problem that I have had with leca is that there does not appear to be much information to work with. Biogen's has a great many presentations on Aducan, though none for leca. Hope, I do not have wait for months for the FDA Briefing Document!

There is also quite a bit of general AD news to catch up on. The recent announcement from Davos about $750 million certainly will need to be scrutinized in a post. There is a lot in the in box that needs to make it to the outbox.

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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Thu Sep 30, 2021 7:47 pm

CDRsb phase 2.GIF
CDRsb dose.GIF
APOE + -.GIF
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