Diskusjon Triggere Porteføljer Aksjonærlister

Nordic Nanovector - Fundamentale forhold 2019 (NANO)

Jeg tror at man gjør seg en bjørnetjeneste ved å kue forventningene noe hva gjelder rekrutteringstakten. 10 land er oppe, og det er ikke alle som har aktive sentre enda. Tror det tar lenger tid enn Q3 før vi når toppfart.

Tror du bør sjekke hva bjørnetjeneste betyr. :wink: Det er like positivt som bjørnemarked.

Du har helt rett, man skal være forsiktig med å forvente for mye om q3, men desto større grunn til å håpe at de har kommet NOE av sted ihvertfall.

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Er det en ting jeg ikke er nervøs for så er det rekruttering, det er kjent at radioimmunotherapy er mest skånsomt for pasienten og det er kun 1 behandling. Det er jo dette pasienter øsnker å få hvis de kan velge selv. PARADIGME vil rekruttere i 80-85 sentere i 20 land, det er klart at ting kommer til å gå fort når ballen begynner å rulle.

Tilbakemeldingene fra pasienter som har fått Betalutin er at behandlingen ikke kjennes på kroppen i noen negativ forstand, i tillegg tviler jeg på at pasienter vil være tilbakeholdne når man får høre om resultatene som så langt har blitt publisert fra de 77 pasientene som har fått dette i Lymrit 37-01.

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Et triks kan jo være å ha en liten pott du leker med, og en annen pott du holder lenger? Det er i allefall min strategi. Har 10% pott jeg trader med og en 90% pott jeg har sittet med siden mars i fjor (all in). Med tradepotten får jeg oppfyllt behovet for action i hverdagen mens jeg ikke mister nattesøvnen om aksjen plutselig stikker.

Solgte tradepotten i dag på 53.70 med gevinst og avventer ny inngang. På denne måten har jeg tjent penger samtidig som jeg kan sove rolig om FPD melding skulle komme i morgen. Begynner å kjenne aksjen såpass godt nå at det ikke var problem å selge på 10%+ opp i dag … :wink:

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Så svaret på spørsmået ditt @optimist1, JA - det er sånne typer på forumet her som drar prisen ned igjen…

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Jeg er godt i trettiåra, og først nå finner jeg ut dette. Hvor mange ganger har jeg fremstått som en idiot uten å være klar over det? Og dette er ikke unikt, høsten 2017 fant jeg ut at Brødrene Gaus, Roms og Brumund var kalt opp etter dalene. Brødrene Dal, you get it? Ikke jeg nei! #støttautismeforeningen #aspergerglein

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Stemmer for at vi kollektivt baisser innrulleringstakt. Evt. realitetsorienterer.

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Samme her. Ikke såå lenge siden jeg skjønte greia…
Satser på å være mindre slow i aksjemarkedet enn på tv programmer.

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Tviler på mitt salg eller salg av den typen har noe som helst å si for kursen, men det er jo kjekt å kunne tro det :slight_smile: Mitt tips om man er langsiktig er å ikke sjekke kursen intradag, men heller bare sjekke sluttkurs. På den måten slipper man å irritere seg over det som er helt naturlig utvikling i en aksje ila. en handelsdag.

La oss si aksjen slutter +3-4% opp. Om man bare sjekker sluttkurs tenker man “wow, dritbra!” om man har fulgt med intradag tenker man “oj shit, den var jo 10% opp! Hvorfor solgte jeg ikke?”.

Don’t hate the player, hate the game… :roll_eyes:

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Hey hey, jeg glemte kanskje en smily. Poenget var at det er tradere som river og sliter i kursen :smiley:

Jeg forstod det. Men det er ikke vits å prøve å spille fotball på glattisen liksom. Det jeg prøver å si er at man må ha en klar strategi, en plan og agere etter den, og justere planen etter terrenget. I de to foregående innleggene er det to konkrete tips til hvordan man kan gjøre nettopp dette.

Husk at tradere betyr likviditet. Hvis alle bare kjøpte og holdt på aksjene ville kursen stått bom stille. For at noen skal selge må det være noen der som vil kjøpe. Det er en symbiose som fungerer etter min mening. Så kan man hate tradere alt man vil for at kursen går opp og ned, men instead of hating kan man heller tenke at de samme traderne som selger nå, er de samme som vil kjøpe ved neste melding.

Og sånn går nu dag’an :wink:

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Hva slags konspirasjoner kan man vel ikke få ut av slikt? Tilfeldig? Neppe! Alarm Alarm! :open_mouth:

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Ikke glem de yngre slektningene i Brødrene Dal og Legenden om Atlant-Is da…
Mange som ikke helt tok referansen til Mikkel Rev, Satosk Rev og Lita Tavle heller…

Liker godt denne meldingen! Mens disse andre potensielt flotte norske selskapenes medisiner viser tall som er litt «hohum, øker dette standard of care da?», så har nano en medisin som fungerer utmerket alene, og potensiellt fantatisk i kombinasjon. Godt å bli minnet på det!

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Jeg vil si det er litt mer enn bare bra at de nå skal bevise at Betalutin gjenåpner/øker opptaket av selve gullstandarden i NHL, nemlig Rituximab :money_mouth_face::+1:
Tipper det vil drastisk øke interessen fra Big Pharma når de har dokumentasjon å vise til gjennom bl.a Archer-1.
Kanskje vi kan se et oppkjøpsbud innen 2019 er omme?
Edit: så fremst de får gode solide data å vise frem da. :+1:

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Nordic Nanovector Announces Betalutin® has been granted Fast Track designation in the US for Follicular Lymphoma

Oslo, Norway, 12 June 2018

Nordic Nanovector ASA (OSE: NANO) announces that the US Food & Drug Administration (FDA) has granted Fast Track designation to Betalutin® (177Lu-lilotomab satetraxetan) for the treatment of patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies.

Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: “We are pleased to have been granted Fast Track designation for Betalutin®. This designation is based on the promising safety and preliminary efficacy data in patients with relapsed/refractory indolent non-Hodgkin’s lymphoma from the first part of the LYMRIT 37-01 study, and highlights the potential of Betalutin® to be a new therapeutic option for these patients. We are now focusing the PARADIGME trial on 3L CD20-refractory FL patients, a population in urgent need of new therapies, and look forward to working with the FDA to advance the development of Betalutin®”.  

PARADIGME is a global randomised Phase 2b clinical trial comparing two Betalutin® dosing regimens (15MBq/kg Betalutin® following 40mg lilotomab pre-dosing; 20MBq/kg Betalutin® following 100mg/m2 lilotomab pre-dosing) in 3L FL patients. PARADIGME aims to enrol 130 patients across 80-85 sites in approximately 20 countries.

The primary endpoint for the study is overall response rate (ORR) and secondary endpoints include duration of response (DoR), progression free survival (PFS), overall survival (OS), safety and quality of life. An initial efficacy and safety data read-out for PARADIGME is targeted for the first half of 2020.

About Fast Track designation

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. The designation provides the opportunity for more frequent meetings with the FDA over the course of drug development. In addition, the Fast Track programme allows for Rolling Review, which enables a company to submit individual sections of its Biologic License Application (BLA) for review as they are ready, rather than waiting until all sections of the BLA are complete, as well as for eligibility for Accelerated Approval and Priority Review if relevant criteria are met.

-End-

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/Isabelle Andrews (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). CD37 is highly expressed in B-cell non-Hodgkin’s lymphoma (NHL), representing a novel therapeutic target. Betalutin® is internalised in tumour cells and prolonged exposure of the nucleus to radiation destroys DNA leading to tumour cell death. Betalutin® also has a crossfire effect limited to a radius of 40 cells, which destroys surrounding tumour cells. Betalutin® has shown promising efficacy and tolerability in the Phase 1/2a LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL) and is currently in a pivotal Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to standard-of-care anti-CD20-based therapy (including rituximab).

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 about the Company can be found at www.nordicnanovector.com

 

Ekstern link: http://news.cision.com/nordic-nanovector/r/nordic-nanovector-announces-betalutin–has-been-granted-fast-track-designation-in-the-us-for-follicu,c2545415

Nyheten er levert av Cision.

http://www.netfonds.no/quotes/release.php?id=20180612.Cision.20180612:BIT:1115:0

1 Like

Nordic Nanovector Announces Betalutin® has been granted Fast Track designation in the US for Follicular Lymphom

Oslo, Norway, 12 June 2018

Nordic Nanovector ASA (OSE: NANO) announces that the US Food & Drug
Administration (FDA) has granted Fast Track designation to Betalutin® (177Lu
-lilotomab satetraxetan) for the treatment of patients with relapsed or
refractory follicular lymphoma (FL) after at least 2 prior systemic therapies.

Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: “We are pleased to have been
granted Fast Track designation for Betalutin®. This designation is based on the
promising safety and preliminary efficacy data in patients with
relapsed/refractory indolent non-Hodgkin’s lymphoma from the first part of the
LYMRIT 37-01 study, and highlights the potential of Betalutin® to be a new
therapeutic option for these patients. We are now focusing the PARADIGME trial
on 3L CD20-refractory FL patients, a population in urgent need of new therapies,
and look forward to working with the FDA to advance the development of
Betalutin®”.

PARADIGME is a global randomised Phase 2b clinical trial comparing two
Betalutin® dosing regimens (15MBq/kg Betalutin® following 40mg lilotomab pre
-dosing; 20MBq/kg Betalutin® following 100mg/m2 lilotomab pre-dosing) in 3L FL
patients. PARADIGME aims to enrol 130 patients across 80-85 sites in
approximately 20 countries.

The primary endpoint for the study is overall response rate (ORR) and secondary
endpoints include duration of response (DoR), progression free survival (PFS),
overall survival (OS), safety and quality of life. An initial efficacy and
safety data read-out for PARADIGME is targeted for the first half of 2020.

About Fast Track designation

Fast Track is a process designed to facilitate the development and expedite the
review of drugs to treat serious diseases and fill an unmet medical need. The
purpose is to get important new drugs to the patient earlier. The designation
provides the opportunity for more frequent meetings with the FDA over the course
of drug development. In addition, the Fast Track programme allows for Rolling
Review, which enables a company to submit individual sections of its Biologic
License Application (BLA) for review as they are ready, rather than waiting
until all sections of the BLA are complete, as well as for eligibility for
Accelerated Approval and Priority Review if relevant criteria are met.

-End-

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/Isabelle Andrews
(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). CD37 is highly expressed in B-cell
non-Hodgkin’s lymphoma (NHL), representing a novel therapeutic target.
Betalutin® is internalised in tumour cells and prolonged exposure of the nucleus
to radiation destroys DNA leading to tumour cell death. Betalutin® also has a
crossfire effect limited to a radius of 40 cells, which destroys surrounding
tumour cells. Betalutin® has shown promising efficacy and tolerability in the
Phase 1/2a LYMRIT 37-01 clinical study in relapsed/refractory follicular
lymphoma (R/R FL) and is currently in a pivotal Phase 2b trial, PARADIGME, in
third line (3L) FL patients who are refractory to standard-of-care anti-CD20
-based therapy (including rituximab).

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 about the Company can be found
at www.nordi

Ekstern link: http://www.newsweb.no/index.jsp?messageId=453411

Nyheten er levert av OBI.

http://www.netfonds.no/quotes/release.php?id=20180612.OBI.20180612S5

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Holy shit!

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