Diskusjon Triggere Porteføljer Aksjonærlister

Nordic Nanovector ASA - Generell tråd (NANO)

Fin avslutning og over all forventning (Når jeg tar historikken til aksjonærene til betraktning).

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Tipper de kan kjøpe etter oppstart av Archer 1 og Paradigme. Akkurat nå så har de vel tett dialog med FDA og sitter sansynligvis med kursdrivende info.

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Costa kjøpte jo 2k på 86kr i juni. Han sitter vel med drøyt 80k til sammen, så spørs kanskje om han føler behovet nå uansett. Som du er inne på…er forhåpentligvis andre ting som ordner kursoppgang fremover :wink:

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“Nordic Nanovector’s Candidate Impresses with Strong Phase I/II Performance
Nordic Nanovector’s lead candidate, Betalutin, is a CD37-targeting Antibody-Radionuclide-Conjugate (ARC), which has been developed to improve the treatment of non-Hodgkin’s Lymphoma. An overall response rate of 60% was observed, a complete response was seen in 24% of patients, and 90% of patients’ tumors reduced in size. Betalutin’s safety profile was also impressive, with only reversible transient neutropenia and thrombocytopenia and a low incidence of infections observed.”

https://labiotech.eu/ash-hematology-blood-news/

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Har en tendens til å miste gangsynet. Fint å kunne zoome litt ut og se hva vi faktisk sitter med her. Medisin. :blush:

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Wow :clap:t2::clap:t2::clap:t2:

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Vet ikke om posta tidligere, men here goes lell:

- Nordic Nanovector ASA ligger i en tilnærmet horisontal trend på mellomlang sikt og videre utvikling i samme retning indikeres. Det ligger støtte i overkant av 68 kroner. På kort sikt stiger kursen på økende volum. Dette indikerer at det er mange kjøpere som vil inn, noe som styrker aksjen. Et brudd opp gjennom 86 kroner vil åpne for videre oppgang mot 110 kroner på kort sikt. Vurdering: Watch, skriver Taugbøl.

http://www.hegnar.no/Nyheter/Boers-finans/2017/12/Analytiker-Foelg-med-paa-disse-aksjene

Hvis du mener min TA med target 105 kr er hauss @Hakon bør du rette kritikken mot Investtech :rofl:

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Eller Dnb med 125, en annen med 145 og den grundige danske, basert på det fundamentale på 170? :grin: så var det en på opptil 220-260 kr også sist vinter/vår vel?

Strålende. :smiley:

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DnB har 145,-

Edit: https://tekinvestor.s3-eu-west-1.amazonaws.com/original/2X/c/cfe233987fe2b505195aa145eb1c574c0047895a.pdf

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Når jeg tenker meg om så finner du mye bra på Savepig sin nettside også, https://nanoinvestors.wordpress.com/nordic-nanovector-analyst-coverage/

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Måtte bare dele denne, selv om de fleste sikkert har fått det med seg :wink:

Remarks from FDA Commissioner Scott Gottlieb, November 30, 2017
Implementing the 21st Century Cures Act: An Update from FDA and NIH

With the advent of more targeted medicines, we’re sometimes able to observe earlier, and in some cases, outsized benefits. This is especially true when it comes to the field of oncology. These situations are compelling us to explore new ways to facilitate and expedite the development and review of these products.

For example, we’re currently examining approaches to better expediting review and approval of these products by leveraging FDA’s existing expedited programs.

Accelerated approval has typically been granted in circumstances where earlier-stage or smaller data sets show benefit for a serious unmet medical need.

But that showing of benefit is typically based on the drug’s effect on a surrogate endpoint.

In these cases, that endpoint, like tumor shrinkage, is judged to be reasonably likely to predict clinical benefit.

**What do we do when we have a targeted drug, introduced in a properly selected group of patients, which has an outsized effect on overall survival in a rare or deadly cancer, but where that benefit is seen in a small trial, where we would still need more evidence to fully understand how to best use the drug in clinical practice? **

We might want to approve such a product earlier, and require a post-market confirmatory study to validate the finding – similar to an accelerated approval approach.

Even though the observed benefit, in this case, is on a clinical endpoint – an early look at survival – and not a surrogate measure of benefit, we believe using an accelerated approval approach often could be valuable.
Congress clarified our authority under FDASIA to grant accelerated approval based on intermediate clinical endpoints. We want to better define what’s meant by intermediate endpoints to ensure that product developers with promising drugs take full advantage of this provision and can consider it in a broader range of such settings.

As the mechanism of diseases, like cancer, become more clearly defined, and drugs targeting these conditions are more carefully tailored to the underlying biology of disease, we’re going to see more such cases – situations where a new drug offers an outsized survival benefit in a selected population of patients in a smaller, early stage clinical trial.

One reason we’d want to consider accelerated approval in these settings is that it would include authority to require confirmatory evidence to support the continued marketing of the drug and an expedited withdrawal mechanism if that evidence fails to confirm the benefit.

We intend to further explore the application of these principles in additional policy work that we’re undertaking.

To fully leverage these opportunities, and in keeping with the spirit of Cures, we’re working on a similar proposal for cancer drugs already approved for one indication – approval for a supplemental application, where the approval concerns a second indication, can sometimes appropriately rely on a more targeted data set, like a single-arm study. We intend to issue guidance further clarifying the circumstances in which this is appropriate.

This may be suitable, for example, when there’s a clear and outsized treatment effect, and the second indication concerns the same disease as the first one, but for a new setting. For example, a targeted drug approved for a third-line use that shows benefit in a second-line indication.

Cures refashioned and modernized FDA’s footprint for enabling new technologies to reach patients more efficiently. It’s given the agency new authorities and resources to invest in our workforce – it shapes the spirit of our mission. We’ll continue to build on its framework.

I look forward to discussing our plans to fulfill and expand on these opportunities, and to answer your questions.

hele saken finner du hær: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587127.htm?utm_campaign=1130207_Statement_Gottlieb%20remarks%20from%2021st%20century%20cures%20Senate%20hearing&utm_medium=em

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Investtech er vel like troverdige som den gjennomsnittlige Hegnar bruker :joy:

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Noen sammenheng her med at NANO har fått brukt 2 linje pasienter?

samme tenkte jeg ;D men jeg vet ikke , men costa og co ser ut som de har tenkt på det meste… får vi gode data nå utover i 2018 på Paradigme studiet (forhåpentligvis med seamless design) og Archer-1 studiet ser det ut som dette kan gå rimelig fort :smiley:

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Klart en fordel at vi allerede har behandlet 2L pasienter og vet nå at Betalutin virker på disse. Det er vel 15 stk vi har behandlet. Blir spennende med archer-1.

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Leser litt på HO og jeg må det er litt artig å lese når “baisserene” bruker risikoen for at Arm 5 er enda bedre enn 20/100 som argument for å selge🤣

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Montebello har du fått svar på mailen du sendte igår!?

Tror nok dette er ment for en medisin som er godkjent for 3L, som de mener bør virke i 2L, så kan de lettere og raskere få AA på 2L.
Men med FDAs nye policy så mener jeg seriøst at Nano burde søke AA på Betalutin i 3FL, pga de beviselig gode resultatene og ikke minst små bivirkninger, spesielt kontra allerede godkjent medisin!
Når januar er nærmere februar så bør de ha enda mer konklusive data, ref dagens CC hvor de sa de ville ha safety og efficacy på flere pasienter “in a few weeks” . Send søknad på nyåret! :+1::+1: