Synes den her var bra.
“For patients this means that they may gain access to a medicine up to 2 years earlier than otherwise.”
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Fin den nye videoen også. Går langt i antyde at Betalutin oppregulerer CD20.
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Hva med: for noen minutter siden 
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Nordic Nanovector’s Betalutin® Receives Promising Innovative Medicine (PIM) Designation in the UK for the Treatment of Follicular Lymphoma
Oslo, Norway, 25 October 2018
Nordic Nanovector ASA (OSE: NANO) today announces that Betalutin® (177Lu-satetraxetan-lilotomab) has been granted a Promising Innovative Medicine (PIM) designation by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of patients with advanced relapsed/refractory follicular lymphoma (R/R FL). The designation was granted based on data from the first part of the Phase 1/2 LYMRIT 37-01 trial.
Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: “We are delighted by the MHRA’s decision to award PIM designation to Betalutin®. This acknowledges the high unmet medical need of this patient population as well as the potential of Betalutin® to offer therapeutic benefits to FL patients. Both the PIM and Fast Track designations (granted by the FDA in June) are very encouraging, as they provide opportunities for enhanced dialogue with health authorities and the potential to bring Betalutin® to patients more quickly.”
PIM designation constitutes Step 1 of the UK Early Access to Medicines Scheme (EAMS). EAMS aims to give patients in the UK early access to medicines that do not yet have a marketing authorisation but meet a medical need that is currently not being met. PIM designation means that a medicinal product is a promising candidate for the EAMS, for the treatment, diagnosis or prevention of life-threatening or seriously debilitating conditions with an unmet need.
For further information, please contact:
IR enquiries
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44 7561 431 762
Email: [email protected]
International Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 638 9571
Email: [email protected]
About Betalutin®
Betalutin® is a tumour-seeking anti-CD37 antibody (lilotomab) conjugated to a low-intensity radionuclide (lutetium-177). It has shown promising efficacy and safety in the first part of the Phase 1/2 LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL). A global, randomised Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to anti-CD20 immunotherapy (including rituximab, RTX) is currently on-going.
Betalutin® is also being investigated in the Phase 1b Archer-1 study in combination with RTX in second-line FL patients, and in the Phase 1 LYMRIT 37-05 study in patients with R/R diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin’s lymphoma (NHL).Betalutin® has been granted Fast Track designation (in June 2018) in the US for the treatment of patients with R/R FL. Betalutin® also received Orphan Drug designations for FL in both the USA and Europe in 2014.
Betalutin® is selective for CD37, which is highly expressed on the surface of B-cell non-Hodgkin’s lymphoma (NHL) cells. When bound to CD37 on tumour cells, Betalutin® is internalised, causing DNA damage and cell death.About Nordic Nanovector
Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company aspires to become a leader in the development of targeted therapies for haematological cancers. Nordic Nanovector’s lead clinical-stage candidate is Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin’s lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 20 billion by 2024. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets. Further information can be found at www.nordicnanovector.com
Nyheten er levert av Cision.
http://www.netfonds.no/quotes/release.php?id=20181025.Cision.20181024:BIT:0586:0
Litt av en hunch…
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Er det fremdeles noen som tviler på at resultatene vi får på ASH holder seg?! 
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Videoen er også betydelig endret siden jeg så den første gang for en måned siden! 
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Lol!
“Betalutin® is a wholly owned asset; clear plan to bring it to market independently in the US”
Fra siste presentasjonen.
Nå blir det jo bare spekulasjoner, men tidligere sto det major markets.
Magefølelsesen sier at det kommer på plass en partneravtale for Europa om ikke så altfor lenge.
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Hehe, ja, det minner vel om avtalen Algeta hadde med Bayer;)
Ja, bortsett fra at den var motsatt.
Der ble det 50/50 i US, mens de hadde royalties for resterende marked mener jeg.
NANO går for en større pott i hvert fall, det er sikkert.
Det applauderes over PIM.
Et solid, og helt nødvendig, steg mot EAMS (UK Early Access to Medicines Scheme) er et faktum.
Dette er så BULL som det kan få blitt.
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Støttes. En endring av det formatet sier mye.
Bravos uttalelse på sist kvartalspresentasjon (“we remain committed to bring Betalutin to readout with the cash we have at hand”) pluss endringer i beskrivelsen av selskapets ambisjoner tyder på at emisjon kanskje ikke blir nødvendig. Spent på å se hva som materialiserer seg fremover og med hvem.
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Må bare minne om at Endocyte, som nettopp ble kjøpt av Novartis for ca 17 milliarder, gikk 1700% på ca 1 år. Så hvis Nano leverer fremover er alt mulig.
Litt hausing må være lov når børsene stuper WW. 
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Det er en risiko nå for at det kommer et skred med positiv informasjon, inkl ASH, og det hele toppes med partneravtale i Europa. Så kjører NANO us-markedet direkte på egen kjøl.
If it looks like a duck, swims like a duck, and quacks like a duck, then it probably is a duck.
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Den klart mest aksjonærvennlige og profitable strategien.
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Når det kommer til partner så tror jeg det vil komme noe i forbindelse med finansieringen av Humalutin. Dette er altfor bra produkt til å ligge i skuffen å støve ned. Når CD37 er validert som target innenfor NHL og lutetium177 også viser seg effektivt, så sier det seg selv at Humalutin er et lavrisiko produkt som ikke fortjener å ligge på hold.
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Haha 
Well done Nostradamus
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Vet du, det er en j… god løsning. Partner for Europa og independent for US. Nano caset blir bare mer og mer gullkantet, om den faller stort mer nå så må jeg snakke med banken.
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For et sørgerlig selskap. Når man ikke får PRIME, så finner man en eller annen obskur designasjon i et eller annet merkelig land.
Dette er som å kjøre opp til bil på Otta.
Bravo. 
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