Anavex HISTORISKE OG BANEBRYDENDE RESULTATER I ALZHEIMER!!!
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Anavex
@TDT123Kan du tolke på calls informationen? Jeg mener, $9 er jo ikke specielt meget. Taler vel for at kursen ikke bevæger sig meget over $9 i dag?
Jeg er ikke sikker på, at jeg helt forstår calls og puts. Reelt er det vel blot endnu en måde at gøre aktiemarkedet til et betting marked - lidt ala shorts.
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Biogen, FDA faulted in congressional inquiry into Alzheimer's drug approval
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Anavex Udmærket Seeking Alpha Biogen kontra Anavex.
Mange gode betragtninger omkring FDA´s afgørelse vedr. Lecanemab den 6. Januar kan have af betydning for Anavex og 2-73.
Bliver Lecanemab f.eks godkendt med restriktioner pga. de alvorlige bivirkninger og dødsfald (som Biogen havde glemt at fortælle om i det 3. tilfælde - det var familien der anmeldte det og ikke Biogen!), så vil Anavex og 2-73 stå meget stærk med en bedre effekt og uden alvorlige bivirkninger!Døm selv - hvad ville man selv ordinerer til et familiemedlem, hvis begge kom på markedet? - og vil Medicare understøtte FDA eller afvise Lecanemab ligesom Aduhelm?
En godkendelse til Levcamemab kunne uanset få en positiv afsmitning på Anavex - og snart med den komplette datapakke fra fase 2/3 ( sandsynligvis på JP Morgan den 12. Januar), så kan man of FDA lave en bedre direkte sammenligning af de to konkurrenter!
Biogen's Alzheimer's Drug Likely To Be Approved With Warning Labels
Dec. 29, 2022 1:41 PM ETBiogen Inc. (BIIB)AVXL, LLY11 Comments
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The Political Economist
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SummaryA new as-yet-unreported death among those taking Biogen's Lecanemab in an extended post-Phase 3 study has emerged.
Biogen's Lecanemab has a PDUFA date of January 6, 2023; the FDA will announce its preliminary (or final) approval or rejection.
Six days later, Anavex Life Sciences will likely announce the final results of its Phase 2b/3 trial for its Alzheimer's drug.
By the 13th, the future of possible Alzheimer's treatments will likely be much clearer.
MRI scan of human brain and skull
haydenbirdPeople can die from the side effects of drugs. It happens every day. Read the warning labels of your pharmaceutical products.
It's not shocking that Biogen/Eisai's (NASDAQ:BIIB) new Alzheimer's medication causes some terrible side effects for a tiny fraction of the people who take the drug, known as Lecanemab. Up until December 20, there were two known deaths from use of Lecanemab in an extension study, post-Phase 3, for Lecanemab.
As reported by Science magazine by journalist Charles Piller, the third patient died of brain swelling and brain bleeding on September 19, 2022, approximately two months before the presentation of final results for Lecanemab's Phase 3 drug trial. Biogen/Eisai did not mention this death in their Lecanemab presentation in November.
Information of the death has only emerged after the deceased's relatives sent medical records and MRI images to the journal Science. The deceased was a 79 year-old Florida woman who was apparently in good health (outside of her Alzheimer's diagnosis) before the drug trial. As reported by Science:
The newly revealed death comes on top [of] other reports of serious brain bleeding and swelling in the core clinical trial and two other deaths in the extension phase-the first reported by STAT and the second by Science-that some scientists have linked to lecanemab.
Biogen/Eisai apparently did not actively deceive. In their final presentation for Lecanemab, they stated that no deaths were caused by Lecanemab in the core study. Indeed, all three deaths occurred during the extension study, which involves 6 weeks of Lecanemab treatments after the core trial is finished.
Whether the woman received infusions of the antibody or a placebo during the core 18-month trial is unclear. But she did get the drug over 6 weeks in the extension phase-in which any participant can opt for treatment. Before the extension trial started, a brain scan revealed signs of a few microhemorrhages, but they were not serious enough to rule her out of the trial.
The woman's family provided Science with MRI scans of the woman's brain before and after use of Lecanemab. The MRIs are disturbing, as distinctive and much larger dark spots appear in the woman's brain MRI after treatment with the Biogen drug. From the photos published in Science, it looks like the woman lost a considerable amount of brain matter as a result of only 6 weeks of treatment!
Most people who see the images of the MRIs would probably conclude that some people likely should not take Lecanemab, especially if there is no benefit from the drug. According to Science, "some large subgroups in the [Lecanemab] trial, including women and people under age 65, did not benefit to a statistically significant threshold" from the drug.
Biogen/Eisai stated in their presentation that the vast majority of patients' brain swelling/bleeding problems occurred early in the use of Lecanemab. So, the fact that all three of the deaths occurred after the extension trial seems to indicate that the three who died were likely part of the placebo group and were being infused with the drug for the first time.
This may indicate that extra care must be taken after each of the first dozen or so Lecanemab treatments. One expert interviewed by Science suggested that 5 MRIs be taken each year while using Lecanemab.
Approval Still Likely
Nevertheless, I believe the FDA will approve Lecanemab. Why? Through its Phase 3 trial, Lecanemab demonstrated with high statistical significance that it can slow cognitive decline over the course of 18 months of treatment. In fact, it slowed cognitive-behavioral decline by an impressive 27% on the CDR-SB (Clinical Dementia Rating scale Sum of Boxes) measurement scale.
While some may see a 27% reduction in decline as clinically insignificant, from the perspective of someone whose mother suffers from Alzheimer's, such a reduction in decline is valued to the extreme.
Furthermore, any given drug will affect different patients differently. It may benefit some people greatly. The average patient showed a 27% reduction in cognitive-behavioral decline. Perhaps some people will see a 50% reduction in decline.
Others, sadly, may potentially die from brain bleeding.
This is the case for most drugs; they help some people and for others, the side effects are too onerous.
Finally, because there has been no effective treatments approved for general use for Alzheimer's patients, I believe the FDA will grant approval when the PDUFA is reported on January 6. It may be preliminary or conditional, but it will be an approval in my view.
AVXL's Blarcamesine
But what if there are other effective treatments, without the brain bleeding? Anavex (AVXL) has presented initial results for a drug, Blarcamesine, which seems to be just as effective (actually better when using as a gauge the ADAS-Cog (Alzheimer's Disease Assessment Scale-Cognitive subscale)). The side effects of Blarcamesine are dizziness and confusion, not brain bleeding.
For a full comparison of the two drugs, see my previous article.
The Anavex drug causes no brain swelling or bleeding because it operates differently. The Anavex drug Blarcamesine is a Sigmar-1 agonist, manipulating the production of the Sigmar chemical in the brain. The Biogen and Eli Lilly (LLY) Alzheimer's drugs both clear amyloid from the brain, and in doing so they cause, for some, brain swelling/bleeding.
Anavex recently concluded a Phase 2b/3 trial for Blarcamesine. The FDA may wish to carefully examine the Anavex trial results before making a decision on the Biogen drug. After all, why approve a drug that has harsh side effects when there is another drug that works arguably just as well, without those deadly side effects?
Conditional Approval
NPR reported that
The [FDA] is expected to consider a conditional approval in early 2023 and a full approval later in the year. If approved, lecanemab is likely to be limited to people in the early stages of Alzheimer's. They make up about 2 million of the 6 million people with the disease.
It's not clear to me why Lecanemab would be limited to those people "in the early stages of Alzheimer's." It seems to me that the FDA would recommend use of Lecanemab for use in people who are least likely to suffer symptomatic brain bleeding.
The FDA may also require those taking Lecanemab to have MRIs done on their brains regularly. Furthermore, the FDA may require Biogen/Eisai to report the results of their extension study to the FDA, if they have not done so already.
By giving Lecanemab conditional approval, the FDA will give itself time to carefully examine Anavex's Blarcamesine results. Depending on that examination, perhaps the FDA can further limit or expand the use-cases for Biogen's Lecanemab. This seems the sensible path to me.
In its communication with Science, Biogen/Eisai already seems resigned to having numerous warning labels slapped on the drug. Eisai responded to Science inquiries in part by suggesting that "for many patients the benefits will outweigh the risks." Hardly a ringing endorsement of its own drug.
The ICER report
The independent review board known as the Institute for Clinical and Economic Review (ICER) is taking the issue of brain bleeding among Lecanemab patients seriously. In their draft review of the drug, they noted that at the time of their writing, two people had died as result of "cerebral macrohemorrhage" in the Lecanemab extension study. I assume they will now examine the third death carefully.
ICER puts a high bar on what are called Minimal Clinically Important Differences (MCID), meaning the minimum difference a drug makes in a patient that can be considered clinically important.
No dementia drug in any Phase 3 trial has ever achieved a MCID by the standards put forth by ICER. The only drug that has come close is Anavex's Blarcamesine. The MCID on the ADAS-Cog scale for Alzheimer's patients is a reduction in cognitive decline by 2 full points. Blarcamesine, on average, reduced cognitive decline by 1.85 points over the course of 48 weeks (11 months). Biogen's Lecanemab only reduced decline in their patients' ADAS scores by 1.44 points over the course of 18 months.
ICER stated that Lecanemab had not met the MCID. To me, this does not mean much. If it were a headache medicine, Lecanemab may not cut the mustard. But because there are no effective treatments for Alzheimer's, I believe the FDA will readily approve any drug that makes any difference.
The question is, how does the FDA take into consideration the side effects of Lecanemab?
Stock Price Predictions
If the FDA grants conditional approval of Lecanemab and tags it with a passel of warning labels, I believe Biogen's stock value finishes the day above 300.
If it is unconditional approval, the stock may break 350.
If the FDA outright rejects Lecanemab, Biogen stock may break 200 on its way down.
If the FDA approves Lecanemab, it will send a signal that Anavex's Blarcamesine, with similar qualities but without the terrible side effects, will certainly be approved in my opinion. The rally in that stock may be quite flagrant.
If the FDA approves but limits Lecanemab's use due to its side effects, it will also likely send AVXL stock up.
If the FDA rejects Lecanemab but only because of its side effects, that may send AVXL stock the highest out of all scenarios presented here, as it will indicate that Lecanemab's treatment results were good but that its side effects are unacceptable. With Anavex's results being better but with no lethal side effects, and with Lecanemab eliminated as competition, AVXL will soar, in my opinion.
If the FDA rejects Lecanemab solely because the FDA believes the medicine is ineffective in treating the symptoms of Alzheimer's disease, then it is unclear what will happen to AVXL stock. Some may buy, as the chief competition has been eliminated; others may sell, worrying that the FDA will also reject Blarcamesine.
Finally, Eli Lilly's Donanemab, on which ICER seemed noncommittal with a negative tilt, will be seen in the same light as Lecanemab. If Lecanemab is approved, Eli Lilly may rally some; if Lecanemab is rejected, LLY will likely take a hit.
In my previous article, I said that I would consider taking Biogen's Lecanemab only after taking Anavex's Blarcamesine for the first two years of treatment. As more information comes out, I lean further on the side of focusing any dementia treatment plan around Anavex's Blarcamesine. While that matter is not urgent, many of us whose parents suffer from Alzheimer's would like to get our hands on safe, effective treatment as soon as possible.
We will learn of the Lecanemab news on January 6, and on January 12, we may learn crucial details about Blarcamesine. Our future health outcomes, if not our financial outcomes, will become clearer within a fortnight.
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Du kan spille på at kursen rammer evt. 8 - 9 - 10 på en given dato, hvis ikke har du tabt din investering, udbyderen af spillet skal nok gøre sit til det ikke sker, så der skal noget positivt FA til hvis du har spillet på Bull, det samme gør sig gælden hvis du har gjort det modsatte....
Andre må rette mig hvis jeg har misforstået det
Mvh
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En kongresundersøgelse har beskyldt Food and Drug Administration (FDA) og Biogen (NASDAQ:BIIB) for at samarbejde "upassende" for at søge det regulatoriske nik for Aduhelm, som i 2021 blev den første amerikansk-godkendte behandling for Alzheimers sygdom i næsten to årtier .
https://seekingalpha.com/news/3921177-biogen-fda-faulted-in-congressional-inquiry-into-alzheimers-drug-approval?utm_source=dlvr.it&utm_medium=twitter -
Ja der er godt nok pudsigt, ha-ha!
Uanset hvad, kan det kun værre til Anavex's fordel, håber jeg.
Hele sagen stinker ad helvede til og er en kæmpe skamplet på FDA's ry! De opfører sig som små konger og følger ikke de regler som de selv har lavet.
Reuters
Congressional report: U.S. FDA broke own protocols in approving Biogen Alzheimer's drugAhmed Aboulenein
Fri, December 30, 2022 at 2:05 AM GMT+8By Ahmed Aboulenein
WASHINGTON (Reuters) - The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen's Alzheimer's drug Aduhelm, which was "rife with irregularities," a congressional report showed on Thursday.
The FDA's interactions with Biogen were "atypical" and did not follow the agency's documentation protocol, according to a staff report on the findings of an 18-month investigation conducted by two House of Representatives committees into the drug's regulatory review, approval, pricing, and marketing.
The FDA approved Aduhelm in June 2021 under an accelerated approval pathway over the objections of its panel of outside advisers, who did not believe data definitively proved the drug's benefit to patients.
It was authorized based on evidence that it could reduce brain plaques, a likely contributor to Alzheimer's, rather than proof that it slowed progression of the lethal mind-wasting disease.
The Medicare program restricted its coverage, which has led to severely limited use of the Biogen drug.
Biogen set an "unjustifiably high" price by initially setting Aduhelm's price at $56,000 per year despite a lack of demonstrated clinical benefit in a broad patient population, the report said, adding that the company's own internal projections showed it expected the drug to be a burden to Medicare and costly to patients.
"The findings in this report raise serious concerns about FDA's lapses in protocol and Biogen's disregard of efficacy and access in the approval process for Aduhelm," the report, prepared by the staffs of the House Committee on Oversight and Reform and House Committee on Energy and Commerce, concluded.
The agency should ensure that all substantive interactions with drug sponsors are properly memorialized, establish a protocol for joint briefing documents with drug sponsors, and update its industry guidance on the developments and review of new Alzheimer's Drugs, the report recommended.
Biogen and other drugmakers should communicate to the FDA any concerns over safety and efficacy to the FDA as well as take value and patient access into consideration when setting prices, the report said.
An FDA spokesperson said the FDA's decision to approve Aduhelm was based on scientific evaluation of the data contained in the application.
He pointed to the FDA's internal review finding its staff's interactions with Biogen appropriate.
"It is the agency's job to frequently interact with companies in order to ensure that we have adequate information to inform our regulatory decision-making. We will continue to do so, as it is in the best interest of patients," he said, adding that the agency will continue to use the accelerated approval pathway whenever appropriate.
The FDA has already begun implementing some of the report's recommendations, the spokesperson said.
"Biogen stands by the integrity of the actions we have taken," the Cambridge, Mass.-based biotech company said in an emailed statement.
"As stated in the congressional report, an (FDA) review concluded that, 'There is no evidence that these interactions with the sponsor in advance of filing were anything but appropriate in this situation,'" Biogen said.
Documents obtained by the committees show that FDA staff and Biogen held at least 115 meetings, calls, and email exchanges over a 12-month period starting July 2019.
The total number of meetings is unknown because the FDA failed to keep a clear record of informal meetings and interactions between its staff and Biogen representatives. The investigation identified an additional 66 calls and email exchanges that were not memorialized.
The FDA inappropriately collaborated with Biogen on a joint briefing document for the Peripheral and Central Nervous System (PCNS) Advisory Committee, the report said, with FDA and Biogen staff working closely for months ahead of the Nov. 6, 2020 meeting to prepare the document, which failed to adequately represent differing views within the agency.
"Using a joint briefing document afforded Biogen advance insight into FDA's responses and direct guidance from the agency in drafting the company's own sections. For example, in an exchange of the draft briefing document on October 9, 2020, FDA staff asked Biogen to move a paragraph drafted by the agency into Biogen's section of the memorandum-a change reflected when the document was finalized," the report made public to media organizations said.
When none of the advisory panel members voted to approve Aduhelm, the FDA pivoted to using its accelerated approval pathway - typically used for rare diseases or small patient populations that lack access to effective treatments - despite having considered the drug under the traditional approval pathway for nine months, the report said.
It did so on a substantially abbreviated timeline, approving it after three weeks of review, and for a broad label indication of "people with Alzheimer's disease" that was unsupported by clinical data, the report said.
Internal documents obtained by the investigation showed that Biogen accepted the indication despite its own reservations over the lack of evidence Aduhelm could help patients at disease stages outside of its clinical trials.
(Reporting by Ahmed Aboulenein; editing by Diane
Craft)https://us.yahoo.com/news/congressional-report-u-fda-broke-180535003.html
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Fox News
Parkinson's disease afflicts thousands more Americans than previous estimates: new studySome 90,000 people are diagnosed with Parkinson's disease (PD) in the United States each year - which is roughly a 50% increase from previous estimated incidence rates, according to a recent 2022 Parkinson's Foundation-backed study.
Hele historien her:
Yahoo News
The latest news and headlines from Yahoo! News. Get breaking news stories and in-depth coverage with videos and photos.
(us.yahoo.com)
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Antallet af syge med Alzheimers og Parkinson er at sammenligne med en epidemi jf flere artikler. Der er udsigt til massiv stigning i tilfældene og dermed voldsom belastning af samfundsøkonomierne.
Missling nævner jævnligt på den kendsgerning.
På den baggrund er det meget fascinerende, at han samtidig påstår, at Blarcamesine kan succesfuldt benyttes profylaktisk.
Anavex har i hvert tilfælde bevist påstanden i dyr - kunne det også vise til at være tilfældet i mennesker var menneskeheden godt hjulpet.
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Anavex "Skandalen og triumfen i kampen mod Alzheimer"
Et forslag til en titel på en bog/dokumentar på hele situationen vi ser og kommer til at se omkring udvikling af gennembruddet i Alzheimer.
Den lilles kamp mod korruption/manipulation i et grådigt system, hvor kolde dollars og ikke patienter velbefindende er hoveddrivkraften.
De store og overmagten, der ikke skyr nogen midler - mod den lille, der trods overbevisende fakta må kæmpe for at blive anerkendt og for første gang reelt at kunne tilbyde en behandling i Alzheimer.
Dette er ikke kun blevet til en "normal" investeringscase, men til et drama, hvor vi står midt i en skelsættende og historisk afgørende situation, der vil få betydning for millioner af patienter fremadrette.
Skal patienter virkelig affinde sig med risikoen for bivirkninger, som hjerneblødninger, opsvulmede hjerner og dødsfald eller er der andre og bedre muligheder, som Anavex, BIVI, SAVA mm.?Inden for de næste uger får vi nok den hidtil største kulmination på dramaet, med det efterhånden vingeskudte FDAs stillingtagen til Lecanemab den 6. januar og så hele datapakken fra Anavex - formodentlig senest på JP Morgan den 12. januar.
Med min naive overbevising om, at videnskaben vil sejre i sidste ende, så ønsker jeg jer herinde på PI, et rigtig godt nytår og tak for den fantastiske konstruktive dialog vi har haft og forsat vil have i det nye år!
Tasso1
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I sidste ende vil det bedste stof sejre.
Ofte er det first on market der er vigtig. Men Lacanemab er så forskellig fra Blarcamesine, at der ingen reel trussel er fra Lecanemab. Bivirkninger, virkning og det faktum at det skal indtages iv (Lecanemab) er afgørende.
Håber at de endelige data for Blacamesine holder, hvad vi forventer. Men tålmodighed skal vi stadig have.
Tak til Tasso1 for at gøre os opmærksom på Anavax og lad 2023 være året hvor aktionærerne belønnes og vigtigst de første pts får behandling.
Godt nytår.
Solsen
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Anavex Peer Review anbefaler nye forsøg med Lecanemab!
Samme Peer Review fra den 29. nov 2022, som iflg. Biogen skal være med til at danne grundlag for en godkendelse hos FDA konkluderer, at man bør lave nye forsøg med Levcamemab, for undersøgelse af den kun MODERATE effekt det har på den cognitive funktion og pga. de SVÆRE BIVIRKNINGER der følger med.
FDA kan derfor blot henvise til denne konklusion i Peer Reviewet og afvise en godkendelse af Lecanemab, med krav om yderligere forsøg/undersøgelser - i princippet meget enkelt!
Som Solsen skriver, så kan det være, at FDA har brændt fingrene så meget sidste gang på Aduhelm, at de denne gang gør det rigtige - trods stort pres fra Biogen, Alzheimer's Association mm.
Den meget kritiske rapport fra kongressen kom, som I har skrevet, på et ekstremt godt tidspunkt - FDA skal virkelig tænke sig godt om!CONCLUSIONS
Lecanemab reduced markers of amyloid in early Alzheimer's disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events. Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer's disease. (Funded by Eisai and Biogen; Clarity AD ClinicalTrials.gov number, NCT03887455 -
Ufatteligt at Anavex ikke er nævnt i denne tweet!
Jeg (og andre) har spurgt hvorfor der er tilfældet.Januar bliver spændende, den 6 januar kommer afgørelsen som bekendt om hjerneblødnings medicinen bliver godkendt eller ej og Missling skal tale den 12 på J.P. Morgan Healthcare Conference, der burde komme nyt før eller samme dag om morgenen ellers vil jeg blive meget skuffet.
https://twitter.com/ProfRobHoward/status/1609169226610130944
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