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Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours



If approved, AstraZeneca and Daiichi Sankyo’s Enhertu will potentially be the first HER2-directed treatment and antibody drug conjugate to receive a tumour-agnostic indication. Application based on results from DESTINY-PanTumor02 trial and supported by additional Enhertu data. Submission to be reviewed under FDA Real-Time Oncology Review and Project Orbis.

AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have received prior treatment or who have no satisfactory alternative treatment options.

The sBLA is based on data from the ongoing DESTINY-PanTumor02 Phase II trial where Enhertu demonstrated clinically meaningful and durable responses leading to a clinically meaningful survival benefit in previously treated patients across HER2-expressing metastatic solid tumours, including biliary tract, bladder, cervical, endometrial, ovarian cancers, and other tumours. Data from other supporting trials in patients with HER2-positive IHC3+ tumours in the Enhertu clinical development programme, including DESTINY-Lung01 and DESTINY-CRC02, were also included in the submission.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the second quarter of 2024.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Today’s Priority Review for the first tumour-agnostic submission for Enhertu reflects the potential of this medicine to redefine the treatment of HER2-expressing cancers. Biomarkers for HER2 expression are already established in breast and gastric cancers, but we must now define them across tumour types. We will continue working closely with the FDA to bring this potential first tumour-agnostic HER2-targeted medicine and biomarker to patients as quickly as possible.”

Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo, said: “The clinical benefit seen across HER2-expressing metastatic solid tumours in the DESTINY-PanTumor02 trial and ongoing data from the Enhertu clinical development programme continues to demonstrate the potential of this medicine beyond its approved indications. If approved, Enhertu could become the first HER2-directed therapy and antibody drug conjugate with a tumour-agnostic indication, providing patients with a potential new treatment option.”

The sBLA is being reviewed under the Real-Time Oncology Review (RTOR) programme and Project Orbis, two initiatives of the FDA which are designed to bring safe and effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners.

Results from DESTINY-PanTumor02 were presented at the 2023 European Society for Medical Oncology Congress and simultaneously published in the Journal of Clinical Oncology.2

The safety profile observed across the trials was consistent with previous clinical trials of Enhertu with no new safety concerns identified.

The Priority Review follows receipt of Breakthrough Therapy Designation (BTD) in the US in August 2023 for Enhertu in metastatic HER2-positive solid tumours.


HER2 expression in solid tumours
HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of various tissue cells throughout the body and is involved in normal cell growth.3,4 In some cancers, HER2 expression is amplified or the cells have activating mutations.3,5 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis.6

While HER2-directed therapies have been used to treat breast, gastric, lung and colorectal cancers, more research is needed evaluating their potential role in treating other HER2-expressing solid tumour types.4,7,8

HER2 is an emerging biomarker in solid tumour types including biliary tract, bladder, cervical, endometrial, ovarian and pancreatic cancers.5 Testing is not routinely performed in these additional tumour types and as a result, available literature is limited. In these solid tumours, HER2-positive expression, classified as IHC 3+, has been observed at rates from 1% to 28%.9,10 There is an unmet need for effective therapies for certain HER2-expressing solid tumours, particularly for those who have progressed on or are refractory to standard of care therapies as there are currently no approved HER2-directed therapies for these cancers.4,11

DESTINY-PanTumor02 is a global, multicentre, multi-cohort, open-label Phase II trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) for the treatment of previously treated HER2-expressing tumours, including biliary tract cancer, bladder cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer or other tumours.

The primary efficacy endpoint of DESTINY-PanTumor02 is confirmed objective response rate (ORR) as assessed by investigator. Secondary endpoints include duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, tolerability and pharmacokinetics.

DESTINY-PanTumor02 has enrolled 267 patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit

DESTINY-Lung01 is a global Phase II, open-label, two-cohort trial evaluating the efficacy and safety of Enhertu (5.4mg/kg or 6.4mg/kg) in patients with HER2-mutant (cohort 2, n=91) or HER2-overexpressing (defined as IHC 3+ or IHC 2+) [cohort 1 and 1a, n=90] unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) who had progressed after one or more systemic therapies.

The primary endpoint is confirmed ORR by independent central review. Key secondary endpoints include DoR, DCR, PFS, OS and safety.

DESTINY-Lung01 enrolled 181 patients at multiple sites, including Asia, Europe and North America. For more information about the trial, visit

DESTINY-CRC02 is a global, randomised, two arm, parallel, multicentre Phase II trial evaluating the efficacy and safety of two doses (5.4mg/kg or 6.4mg/kg) of Enhertu in patients with locally advanced, unresectable or metastatic HER2-positive colorectal cancer of BRAF wild-type, or RAS wild-type and RAS mutant tumour types previously treated with standard therapy.

The trial was conducted in two stages. In the first stage, patients (n=80) were randomised 1:1 to receive either 5.4mg/kg or 6.4mg/kg of Enhertu. In the second stage, additional patients (n=42) were enrolled in the 5.4mg/kg arm.

The primary endpoint is confirmed ORR as assessed by blinded independent central review. Secondary endpoints include DoR, DCR, investigator-assessed confirmed ORR, clinical benefit ratio, PFS, OS and safety.

DESTINY-CRC02 enrolled 122 patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit

Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads, (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4mg/kg) is approved in more than 55 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a (or one or more) prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in more than 45 countries for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/in-situ hybridisation [ISH]-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved in more than 30 countries worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally-approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 trial. Continued approval in the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial and/or DESTINY-Gastric02 trial.

Enhertu development programme
A comprehensive clinical development programme is underway globally, evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Daiichi Sankyo collaboration
Daiichi Sankyo Company, Limited (TSE: 4568) [referred to as Daiichi Sankyo] and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and datopotamab deruxtecan.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit and follow the Company on Social Media @AstraZeneca.

For details on how to contact the Investor Relations Team, please clickhere. For Media contacts, click here.


  1. FDA. Priority Review. Available at: Accessed January 2024.
  2. Meric-Bernstam F, et al. Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-PanTumor02 Phase II Trial. J Clin Oncol. 2023 Oct;42:47-58.
  3. ASCO. Breast Cancer. Available at: Accessed January 2024.
  4. Iqbal N, et al. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014; 852748.
  5. Omar N, et al. HER2-an emerging biomarker in non-breast and non-gastric cancers. Pathogenesis. 2015;2(3):1-9.
  6. Pillai R, et al. HER2 mutations in lung adenocarcinomas: A report from the Lung Cancer Mutation Consortium. Cancer. 2017;1;123(21): 4099-4105.
  7. National Cancer Institute. Enhertu Marks First Targeted Therapy for HER2-Mutant Lung Cancer. Available at: Accessed January 2024. 
  8. Siena S, et al. Targeting the Human Epidermal Growth Factor Receptor 2 (HER2) Oncogene in Colorectal Cancer. Ann Oncol. 2018 May;29(5):1108-1119.
  9. Yan M, et al. HER2 expression status in diverse cancers: review of results from 37,992 patients. Cancer Metastasis Rev. 2015 Mar;34(1):157-64.
  10. Buza N, et al. Toward standard HER2 testing of endometrial serous carcinoma: 4-year experience at a large academic center and recommendations for clinical practice. Modern Pathology. 2013 Dec;26(12):1605-12.
  11. Meric-Bernstam F, et al. Pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer (MyPathway): an updated report from a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2019 Apr;20(4):518-530.
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Ledamöter i kommittén En svensk kulturkanon förordnade




Ledamöter i kommittén En svensk kulturkanon (Dir. 2023: 180) har nu förordnats av kulturminister Parisa Liljestrand.

–Nu har vi en kompetent kommitté på plats. Jag ser fram emot att följa deras arbete med att ta fram en kulturkanon som ska bli ett levande och användbart verktyg för bildning, gemenskap och inkludering. Att ta fram en kulturkanon handlar om att göra svensk kultur tillgänglig för fler, säger kulturminister Parisa Liljestrand.

Kommittén ska bland annat

• utse konst- och kulturområden som ska ingå i en svensk kulturkanon,

• fastställa vilka kriterier som ska gälla vid valet av verk till en svensk kulturkanon,

• utse deltagare i expertgrupper utifrån sakkompetens inom respektive område,

• uppdra åt varje expertgrupp att självständigt, enligt de kriterier som kommittén fastställt, avgöra vilka verk som ska ingå i en svensk kulturkanon inom det område som gruppen svarar för,

• sammanställa en svensk kulturkanon av de verk som väljs ut av expertgrupperna,

• skapa en öppen och inkluderande process vid framtagandet av en svensk
kulturkanon där allmänheten ges möjlighet att komma med förslag, och

• föreslå hur en svensk kulturkanon ska kunna hållas relevant över tid.

Som ledamöter i kommittén förordnas:

Marlen Eskander, verksamhetsledare Läsfrämjarinstitutet                                         
Gunilla Kindstrand, journalist
PJ Anders Linder, chefredaktör Axess
Peter Luthersson, docent
i litteraturvetenskap


Regeringen beslutade den 21 december 2023 om direktiv till den kommitté som ska ta fram en svensk kulturkanon. Ordförande i kommittén är professorn och historikern Lars Trägårdh. Kommittén inleder sitt arbete den 1 mars 2023 och uppdraget ska redovisas senast den 31 augusti 2025.

Sara Persson
Pressekreterare åt kulturminister Parisa Liljestrand
Mobil: 076-112 78 19

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FX International AB (publ) avlämnar bokslutskommuniké för fjärde kvartalet 2023




Sammanfattning av perioden

Januari – december 2023

Rörelseresultat: -8 348 KSEK (-1 565 KSEK)

Finansiella intäkter och kostnader: 0 KSEK (185 KSEK)

Resultat före skatt: -11 975KSEK (-1 380 KSEK)

Resultat per aktie efter skatt: -0,21 SEK (-0,024 SEK)

Oktober – december 2023

Rörelseresultat: -3 477 KSEK (288 KSEK)

Finansiella intäkter och kostnader: -24 KSEK (42 KSEK)

Resultat före skatt: -3 501 KSEK (330 KSEK)

Resultat per aktie efter skatt: -0,61 SEK (0,006 SEK)

Kommande finansell kalender

Delårsrapport 31 maj 2024
Halvårsrapport 30 augusti 2024
Delårsrapport 29 november 2024
Bokslutskommuniké (Q4) 28 februari 2025

VD kommentar

Vi lämnar bakom oss ett minst sagt utmanande år med inflation och geopolitiska konflikter som bidragit till ett svårt ekonomiskt klimat för oss och många andra. För oss inom SME-segmentet med fortsatt tillväxtresa framför oss har det ekonomiska klimatet inneburit svårigheter att hålla i den uppåttrend som vi efter förra årsbokslutet såg framför oss. Jag och styrelsen har under 2023 fortsatt att arbeta utefter strategin som vi startade hösten 2020 och som vi sedan dess följt.

Vi har sedan 2020 genomgått en större omorganisation och tagit steget mot att utöka vår verksamhet med ytterligare investeringsprodukter samt förändrat bolagsstrukturen genom förvärv. Trots att turbulenta globala händelser utom vår kontroll avlöst varandra har vi fortsatt utveckla FXI med målsättning att skapa goda investeringsmöjligheter inom vårt fondbolag, AI2 SICAV plc, samt adderat ytterligare affärsmodeller till vår verksamhet genom förvärv. Vårt förvärv, och kommande förvärv, genomförs för att bredda vår verksamhet till att omfatta fler områden där olika affärsinriktningar bidrar till att skapa synergier och främja samarbete inom marknadssektorer, affärssegment och teknologi med syfte att skapa förutsättningarna för både organisk och förvärvad tillväxt.

Under 2023 initierade FXI förvärvet av ett danskt finansbolag som lyder under danska Finanstilsynet (Finansinspektionen), Villand Capital ApS. FXI har genom förvärvet nu möjlighet att agera rådgivare till institutioner, vilket skapar synergier med AI2 SICAV plc. Utöver ovan har Villand Capital ApS även en Corporate Finance verksamhet och försäljningsorganisation där nära samarbetsmöjligheter och synergieffekter med Genova Nordic SME Fund föreligger.

Det gångna året har för vår fortsatta tillväxtresa varit oerhört positivt. Nya affärsmöjligheter har tillförts och förberedelser för fortsatta strukturaffärer har initierats och när vi går in i 2024 gör vi det med fler affärsinriktningar och med förutsättningar att utveckla de affärsmodeller som FXI har.

Även om vi ser ytterst positivt på det gångna året så går det inte att bortse från att vi har varit tvungna att hantera negativa utspel och påståenden från företrädare från Tikspac AB, påståenden som varit osanna och grundlösa. Styrelse och ledning har tillsammans fått ägna allt för mycket tid på att hantera dessa utspel, vilket tagit fokus från vårt arbete med vår verksamhet och hindrat oss i vår affärsutveckling under 2023.

Framöver är det vår affärsfilosofi att fortsätta utveckla och förbättra verksamheten genom ytterligare förvärv där synergier mellan affärsmodeller skapar förutsättningar för internationell marknadspositionering, bidrar till affärsutveckling, kompletterar nuvarande affärsområden och medverkar till ett långsiktigt hållbart värdeskapande för FXI, investerare och aktieägare.

Våra driftkostnader under 2023 har ökat till följd av inflation och affärsutveckling, vi ser inte en fortsatt ökning av fasta kostnader under 2024. Den negativa utvecklingen i SME-marknaden har även påverkat våra investeringar. Vi har dock tillförsikt inför 2024 och en comeback för SME-marknaden. Framöver hoppas vi, som så många andra, att marknaden för små- och medelstora bolag vänder uppåt och att även de får större intresse under 2024.

Under 2024 förväntar vi oss en positiv påverkan på vårt resultat genom vårt nyförvärv Villand Capital ApS. Dessutom blir 2024 ett intressant utvecklingsår med fler möjliga förvärv inom den finansiella sektorn.

Vi tackar alla de som stöttat oss under det gångna året!

Sofie Danielsson, verkställande direktör

FX International AB (publ)

Sofie DanielssonCEO+46 (0) 708

FX international AB (publ) arbetar med egen förvaltning och erbjuder alternativa investeringsprodukter till professionella och instutionella investerare genom sitt fondbolag, AI2 SICAV plc. Bolaget innehar även en egenutvecklade valutahandelsplattform, Genova FX. Handeln sker genom statistiska modeller optimerade med artificiell intelligens.

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NSW Ambulance service i Australien rapporterar om goda resultat från ambulansstudie med MD100 Strokefinder




Medfield Diagnostics meddelar att New South Wales Ambulance Service rapporterar i en mediarelease om goda erfarenheter från användningen av MD100 Strokefinder i en ambulansstudie.

John Hunter Hospital, New South Wales Ambulance Service och Stroke Alliance genomför en ambulansstudie med MD100 Strokefinder. Paramedic Immediate Care Units (PICU) från New South Wales Ambulance Service har med hjälp av MD100 Strokefinder bedömt cirka 100 patienter i samband med larm om en misstänkt stroke.

Media release:” NSW Ambulance first in the world to trial new stroke care technology” Länk : NSW Ambulance first in the world to trial new stroke care technology –

A world-first collaborative trial will see cutting-edge technology used by NSW Ambulance as part of the rapid assessment and triage of stroke patients as they are transported to hospital.

A revolutionary new brain scanner, the Medfield Diagnostics Strokefinder MD100 helmet, is currently being piloted by NSW Ambulance paramedics in the Hunter region, the first time the Strokefinder helmet technology is being utilised on the frontline and outside of hospital.

Minister for Regional Health Ryan Park said this innovative trial could enable even faster stroke diagnosis and treatment, meaning more patients stand to benefit from timely stroke interventions in the vital ‘golden hour’.

“Stroke is a time critical emergency and is one of Australia’s biggest killers, so the earlier our paramedics and neurologists can assess and treat patients, the better the outcome,” Mr Park said.

“I am really proud our NSW Ambulance paramedics are the first in the world to use this device in the pre-hospital setting.

“This is a wonderful example of some of the truly collaborative projects taking place across the health system right now, where cutting-edge technology and our highly skilled hospital clinicians and frontline paramedics work together.”

NSW Ambulance Commissioner Dr Dominic Morgan said the technology is fast to operate and performs multiple brain measurements in 60 seconds.

“This exciting study brings together NSW Ambulance intensive care paramedics and John Hunter Hospital neurologists, and the Hunter Medical Research Institute, to evaluate the feasibility of the Strokefinder MD100 helmet in pre-hospital care,” Dr Morgan said. “When combined with an innovative telehealth app, our paramedics on the ground are able to consult with the neurology team in the hospital to optimise the care and overall outcome for the stroke patient.”

Acute Stroke Services Neurologist at John Hunter Hospital and study lead, neurologist Professor Chris Levi, said clinicians and researchers will work together closely to evaluate and refine how the stroke detection system and telehealth app can optimise frontline care.

“When a stroke occurs, rapid and accurate diagnosis is vital to speed up the delivery of treatment interventions and improve clinical outcomes for the patient,” Professor Levi said.

Preliminary data from the trial shows almost all patients were scanned within an hour of the Triple Zero call being made.

Minister for Medical Research David Harris said these results of the trial have been remarkable considering less than five per cent of stroke patients in Australia undergo a hospital CT scan within an hour of suffering a stroke.

“Although still in the research phase, this innovation allows paramedics to rapidly scan the brain, hopefully within what’s known as the ‘golden hour’ after a stroke occurs which is when we can optimise treatment outcomes for the patient,” Mr Harris said.Jack Di Tommaso, a 27-year-old gym owner and personal trainer from Newcastle, recently completed a marathon when an ischaemic stroke gave him and his family the shock of their lives. Jack didn’t know what to make of his sudden symptoms, which included slurred speech and reduced consciousness.

Thanks to this trial, the Strokefinder MD100 scan was performed on Jack within the ‘golden hour’ after suffering a stroke and his clinical information was captured in the telehealth app.

Jack said he felt lucky to be treated so quickly thanks in part to this ground-breaking trial.

“I’m grateful my mate called Triple Zero straight away, the paramedics arrived minutes later and were amazing from start to finish,” Jack said.

“I was scanned by the Strokefinder helmet and examined on a video call direct to the neurologist at hospital This collaboration and quick response was a major factor in making a full recovery.”

Minister for the Hunter Yasmin Catley said regional Australians are 17 percent more likely to suffer a stroke than those in metropolitan areas.

”In the Hunter New England Health District, around 1,500 residents experience a stroke each year, so it makes sense a trial like this would take place here,” Ms Catley said.

Member for Wallsend Sonia Hornery said she was proud clinicians from John Hunter Hospital are involved in the trial.

“Some of our best and brightest work at John Hunter Hospital, and for them to be involved this frontline research which is improving outcomes for people suffering a stroke is really fantastic,” Ms Hornery said.

NSW Ambulance in partnership with Hunter New England Local Health District, Medfield Diagnostics, Hunter Medical Research Institute, and Titan Neuroscience Research Australia, anticipate reporting trial results later this year.

För mer information kontakta:
Björn Larsson CEO, Medfield Diagnostics AB, tel+46 766 201 725

Medfield Diagnostics har som mål att underlätta diagnostiseringen av stroke och huvudtrauma. Om man på ett tidigt stadium kan avgöra om patienten har en stroke eller inte, skulle behandlingsprocessen kunna påskyndas och rätt behandling sättas in betydligt tidigare än idag. Därigenom kan det elimineras mycket lidande hos drabbade patienter och det skulle kunna sparas mycket stora vård- och rehabiliteringskostnader för samhället.

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