Betalutin. MHRA-Positive scientific opinion or a BLA from FDA
.............................. When ? Before summertime ?
From Internett
From Nordic Nanovecter : Primary focus on the clinical development of Betalutin® to achieve first regulatory filing in 3rd line FL, and in parallel to run additional trials in 2nd line FL with a combination of Betalutin® and rituximab.
-----------------------------
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.
The MHRA grants permission for all clinical trials to be conducted in the UK, after an MHRA scientific meeting
2nd line for Betalutin is ongoing with clinical trial - Lymrit 37/01 and 37/07
Link for 37/07 from WHO - 3 different country - Norway / EU / Great Britain
http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2017-004506-18-NO
---------------------------------------------------
The PIM designation, granted after an MHRA scientific meeting.
PIM is the first stage in the UK's Early Access to Medicines Scheme (EAMS), which aims to provide a way for patients with serious diseases to get access to new therapies before a European license has been granted. In the UK, for example, the program is called "early access to medicine scheme" or EAMS. If a company that wants to provide a drug under EAMS, it must submit its Phase I data to the Medicines and Healthcare products Regulatory Agency and apply for what is called a "promising innovative medicine" (PIM) designation.
After the PIM designation, the next stage is the Early Access Scientific Opinion. If the MHRA decides that doctors can prescribe the drug, the positive scientific opinion lasts for a year. The company can then apply to renew it. A positive scientific opinion through the Early Access to Medicines Scheme, adults in the UK can gain access to a new drug, before the drug is granted marketing authorization / licences
The Early Access to Medicines is a process that aims to give people access to promising new drugs that are not yet licensed. The licensing process for drugs makes sure:
They are safe
They work
The benefits outweigh any possible side effects
The medicines might still be part of ongoing research or they may be waiting to be licensed.
Licences confirm the health condition the medicine should be used for, and the recommended dosage, but MHRA allows using a medicine at a higher dose than stated in the licence, after a Scientific Opinion from MHRA. ( restrictions to the maximum dose or maximum daily dose )
--------------------
Zinzani PL
Radioimmunotherapy for Follicular Lymphoma achieves long term lymphoma control in first line and at relapse: 8-year follow-up data of 281 patients from the international RIT-registry
https://www.ncbi.nlm.nih.gov/pubmed/30515751
------------------------------
The positive scientific opinion lasts for a year.
From Internett
From Nordic Nanovecter : Primary focus on the clinical development of Betalutin® to achieve first regulatory filing in 3rd line FL, and in parallel to run additional trials in 2nd line FL with a combination of Betalutin® and rituximab.
-----------------------------
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.
The MHRA grants permission for all clinical trials to be conducted in the UK, after an MHRA scientific meeting
2nd line for Betalutin is ongoing with clinical trial - Lymrit 37/01 and 37/07
Link for 37/07 from WHO - 3 different country - Norway / EU / Great Britain
http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2017-004506-18-NO
---------------------------------------------------
The PIM designation, granted after an MHRA scientific meeting.
PIM is the first stage in the UK's Early Access to Medicines Scheme (EAMS), which aims to provide a way for patients with serious diseases to get access to new therapies before a European license has been granted. In the UK, for example, the program is called "early access to medicine scheme" or EAMS. If a company that wants to provide a drug under EAMS, it must submit its Phase I data to the Medicines and Healthcare products Regulatory Agency and apply for what is called a "promising innovative medicine" (PIM) designation.
After the PIM designation, the next stage is the Early Access Scientific Opinion. If the MHRA decides that doctors can prescribe the drug, the positive scientific opinion lasts for a year. The company can then apply to renew it. A positive scientific opinion through the Early Access to Medicines Scheme, adults in the UK can gain access to a new drug, before the drug is granted marketing authorization / licences
The Early Access to Medicines is a process that aims to give people access to promising new drugs that are not yet licensed. The licensing process for drugs makes sure:
They are safe
They work
The benefits outweigh any possible side effects
The medicines might still be part of ongoing research or they may be waiting to be licensed.
Licences confirm the health condition the medicine should be used for, and the recommended dosage, but MHRA allows using a medicine at a higher dose than stated in the licence, after a Scientific Opinion from MHRA. ( restrictions to the maximum dose or maximum daily dose )
--------------------
Zinzani PL
Radioimmunotherapy for Follicular Lymphoma achieves long term lymphoma control in first line and at relapse: 8-year follow-up data of 281 patients from the international RIT-registry
https://www.ncbi.nlm.nih.gov/pubmed/30515751
------------------------------
The positive scientific opinion lasts for a year.
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Frontmasta
25.05.2019 kl 21:56
3785
Sperimentazioni 2019...........
For de første 50 pasientene, ca. 25 for hver arm, vil en midlertidig analyse utføres for å vurdere ugunstighet i fase II .Målet er å evaluere effekten av 40 mg lilotomab / 15 MBq / kg Betalutin sammenlignet med 100 / 20
https://sperimentazionicliniche.it/
Lymrit 37 01.....................
https://www.orpha.net/consor/cgi-bin/ResearchTrials_ClinicalTrials.php?lng=IT&data_id=116181&Nom%20d
https://www.ospedale.al.it/wp-content/uploads/2016/11/News_Sperimentazioni_2019_10.pdf
For de første 50 pasientene, ca. 25 for hver arm, vil en midlertidig analyse utføres for å vurdere ugunstighet i fase II .Målet er å evaluere effekten av 40 mg lilotomab / 15 MBq / kg Betalutin sammenlignet med 100 / 20
https://sperimentazionicliniche.it/
Lymrit 37 01.....................
https://www.orpha.net/consor/cgi-bin/ResearchTrials_ClinicalTrials.php?lng=IT&data_id=116181&Nom%20d
https://www.ospedale.al.it/wp-content/uploads/2016/11/News_Sperimentazioni_2019_10.pdf
Redigert 20.01.2021 kl 19:46
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Her høres det ut som du har noe relevant info. Kan du please skrive mer sammgengende og linke til informasjonen din ( med linker som fungerer)
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Frontmasta
25.05.2019 kl 20:57
3850
Les hvorfor media i bla USA og UK publiserer nyheteter om Betalutin ...... NN har ikke kapasitet til å levere nok doseringer, derfor vil mange produsenter etablere nye produksjonslokaler leste jeg på Internett ..........Bravo søker partnere, men partrene får beskjed om å må vente til avlesningene av 25 i hver arm av Paradigmene er ferdige, før videre forhandlinger fortsetter. Bravo vet at inngangsbiletten blir høyere når myndighetene på andre siden av nordsjøen har sagt sitt. Bravo har det ikke travelt når BP ringer
Some of our past and current clients include ......... MGB Biopharma, Nordic Nanovector, Novexel (acquired by AstraZeneca), ThromboGenics and Transgene........
www.citigatedewerogerson.com
Is Nordic Nanovecter the new clients to ...........................
Some of our past and current clients include ......... MGB Biopharma, Nordic Nanovector, Novexel (acquired by AstraZeneca), ThromboGenics and Transgene........
www.citigatedewerogerson.com
Is Nordic Nanovecter the new clients to ...........................
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TeeJay
24.05.2019 kl 21:44
4089
Vi er for dumme masta, du må hjelpe oss.
Jeg søkte, fant siden... men den forteller meg infenting av verdi
Jeg søkte, fant siden... men den forteller meg infenting av verdi
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Frontmasta
24.05.2019 kl 20:51
4131
Så kom bekreftelsen på avlesningene fra ledelsen, og aksjemarkedet får ingen info om resultatene som beskrevet over.
Søk på bla følgende info i helga, så skjønner man hva ledelsen mener med partner
Medicon Valley Alliance is continually adding new life science companies and organisations as members. These companies and organisations have decided to join forces and strengthen their ties within the region, thereby anhancing their visibility with national and international companies looking at life science in Medicon Valley.Below is a list of the companies that have recently joined the Medicon Valley Alliance!. Take a look and see if one of them is your new business partner. ........
Søk på bla følgende info i helga, så skjønner man hva ledelsen mener med partner
Medicon Valley Alliance is continually adding new life science companies and organisations as members. These companies and organisations have decided to join forces and strengthen their ties within the region, thereby anhancing their visibility with national and international companies looking at life science in Medicon Valley.Below is a list of the companies that have recently joined the Medicon Valley Alliance!. Take a look and see if one of them is your new business partner. ........
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Sydney
13.05.2019 kl 11:33
4439
Dette er linken?? Vi bruker 100 Mill i kvartalet og du linker til at Nano har fått 75000 i offentlig støtte??
Redigert 20.01.2021 kl 19:46
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Frontmasta
13.05.2019 kl 11:30
4450
Kilde:
Forskningsrådet
Prosjektleder:
Chief Scientific Officer Jostein Dahle
Prosjektnummer:
299917
Søknadstype:
Prosjektetableringsstøtte
Prosjektperiode:
2019
Tildelt:
75 000 kr
Midlene er mottatt fra:
PES2020 — Prosj.etabl.støtte H2020
Organisasjon:
Næringsliv Næringsliv NORDIC NANOVECTOR ASA
Geografi: Oslo / Oslo
Sammendrag
The purpose of this EU project is to bring Betalutin®, to the market as the treatment of choice for relapsed refractory 3rd line Follicular Lymphoma patients. NHL is the 10th most common cancer and the most common type of blood cancer. Follicular lymphoma (FL) accounts for roughly 22% of NHL cases. FL is an incurable disease characterised by alternating periods of remission and relapses, and there is a need for new treatments less toxic than chemotherapy, particularly in patients who have already failed many prior lines of therapy
d) the development of the regulatory documents necessary for filing the biologics licence application.
Forskningsrådet
Prosjektleder:
Chief Scientific Officer Jostein Dahle
Prosjektnummer:
299917
Søknadstype:
Prosjektetableringsstøtte
Prosjektperiode:
2019
Tildelt:
75 000 kr
Midlene er mottatt fra:
PES2020 — Prosj.etabl.støtte H2020
Organisasjon:
Næringsliv Næringsliv NORDIC NANOVECTOR ASA
Geografi: Oslo / Oslo
Sammendrag
The purpose of this EU project is to bring Betalutin®, to the market as the treatment of choice for relapsed refractory 3rd line Follicular Lymphoma patients. NHL is the 10th most common cancer and the most common type of blood cancer. Follicular lymphoma (FL) accounts for roughly 22% of NHL cases. FL is an incurable disease characterised by alternating periods of remission and relapses, and there is a need for new treatments less toxic than chemotherapy, particularly in patients who have already failed many prior lines of therapy
d) the development of the regulatory documents necessary for filing the biologics licence application.
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TeeJay
03.05.2019 kl 11:13
4851
Å som jeg hadde likt om det engang var noe substans i disse tåkete meldingene dine masta.
De gjelder jo ofte potensiell interessant info, men det er jo bare fragmenterte glimt som sjelden fører noen noe sted.
De gjelder jo ofte potensiell interessant info, men det er jo bare fragmenterte glimt som sjelden fører noen noe sted.
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Sydney
03.05.2019 kl 00:22
5096
Har du noe link? Haha du sa jo at det var aprtner avtale på gang også. Dvs at de ikke er ferdig med 50 pasienter i paradigme enda da?
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Sydney
03.05.2019 kl 00:00
5130
Phase III oncology trials compare the efficacy
of the new drug/regimen to the current standard of care and usually enrol hundreds of patients,
depending on the tumour type. If a drug is successful in all three clinical phases, a New Drug
Application ("NDA") or a Biologic License Application ("BLA") is submitted to the FDA. The
NDA/BLA contains all information obtained during the testing phase. The Regulatory Authority
then completes an independent review and makes its recommendations. The standard time of
review is 9 to 12 months. If the product is approved, then it can be marketed
of the new drug/regimen to the current standard of care and usually enrol hundreds of patients,
depending on the tumour type. If a drug is successful in all three clinical phases, a New Drug
Application ("NDA") or a Biologic License Application ("BLA") is submitted to the FDA. The
NDA/BLA contains all information obtained during the testing phase. The Regulatory Authority
then completes an independent review and makes its recommendations. The standard time of
review is 9 to 12 months. If the product is approved, then it can be marketed
Redigert 20.01.2021 kl 19:46
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Frontmasta
02.05.2019 kl 23:09
5217
Da ble det BLA søknad, og når avlesningsresultatene til første 50 pasientene i Paradigme er klare så vil dataene fremlegges for myndighetene i England og i Amerika. Dataene blir sannsynlig ikke fremlagt for markedet, men hva myndighetene bestemmer seg for er "hot news'
Etter at NN fikk innvilget den første milepælen i UK og USA er det bare å vente på neste steg................
I ventetiden fremover vil nok robottene herje med aksjekursen.
Etter at NN fikk innvilget den første milepælen i UK og USA er det bare å vente på neste steg................
I ventetiden fremover vil nok robottene herje med aksjekursen.
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Frontmasta
16.01.2019 kl 22:59
5990
Aksjemarkedet har fått melding om innvilget steg I - etter at godkjenningen var gitt. Ingen børsmelding er sendt aksjemarkedet om at de hadde søkt / skulle søke.
Får aksjemarkedet melding om søknad / behandling mv av steg II
Får aksjemarkedet melding om søknad / behandling mv av steg III..............preliminary positive opinion. Svar foreligger 45 dager etter søknaden er sendt.
Man må fullføre alle 3 stegene før man sender søknad om Market authorization for Betalutin en gang i 2020.
Er det slik å forstå at MHRA er bombastiske i utøvelsen av tidsfrister, før ledelsen sender søknad om Market Authorization Application for Betalutin ............NOPE
Les bl.a om : How long is the EAMS period ? While the scheme was originally intended to be in place for 12-18 months for eligible medicines, in practice the EAMS periods have been very brief with some in place for only a few weeks.
Fra denne linken
http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/adtc_collaborative/eams_operational_guidance/info_on_eams_in_nhsscotland.aspx
Nå holder ledelsen på med 4 studier, og husk at dette gjelder for alle.
Sometimes, trials may close early because one treatment / dose is clearly better than another. It is not ethical to continue to give you a treatment if the researchers know it is not as good as another treatment. If this happens, you are switched to the better treatment if possible.
Turboen er koblet inn i UK for ledelsen må få til en eller annen form for godkjenning, lenge før pengekassen er tom. Det må til før en partneravtale - aksjeutvidelse eller lån kan avtales
En ting er sikkert, kursen vil bli sendt opp og ned, opp og ned, og nedover og oppover av de som kjøper og selger promiller av aksjene. Gode meldinger .............. Før sommeren ?
Får aksjemarkedet melding om søknad / behandling mv av steg II
Får aksjemarkedet melding om søknad / behandling mv av steg III..............preliminary positive opinion. Svar foreligger 45 dager etter søknaden er sendt.
Man må fullføre alle 3 stegene før man sender søknad om Market authorization for Betalutin en gang i 2020.
Er det slik å forstå at MHRA er bombastiske i utøvelsen av tidsfrister, før ledelsen sender søknad om Market Authorization Application for Betalutin ............NOPE
Les bl.a om : How long is the EAMS period ? While the scheme was originally intended to be in place for 12-18 months for eligible medicines, in practice the EAMS periods have been very brief with some in place for only a few weeks.
Fra denne linken
http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/adtc_collaborative/eams_operational_guidance/info_on_eams_in_nhsscotland.aspx
Nå holder ledelsen på med 4 studier, og husk at dette gjelder for alle.
Sometimes, trials may close early because one treatment / dose is clearly better than another. It is not ethical to continue to give you a treatment if the researchers know it is not as good as another treatment. If this happens, you are switched to the better treatment if possible.
Turboen er koblet inn i UK for ledelsen må få til en eller annen form for godkjenning, lenge før pengekassen er tom. Det må til før en partneravtale - aksjeutvidelse eller lån kan avtales
En ting er sikkert, kursen vil bli sendt opp og ned, opp og ned, og nedover og oppover av de som kjøper og selger promiller av aksjene. Gode meldinger .............. Før sommeren ?
Redigert 20.01.2021 kl 19:46
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Frontmasta
13.01.2019 kl 15:12
6870
Det forskjell på en klinisk studie og et studieoppsett.
Nordic Nanovecter kommer nok til å søke full godkjenning når resultatene fra Paradigme foreligger. Nordic Nanovecter har for flere år siden lagt en plan sammen med myndighetene i Storrbritania og hva denne planen innebærer fult ut har ikke ledelsen fortalt mye om, men hovedgrunnen er at medisinen skal nå pasientene snarest mulig
Her er linken for Paradigme - Lymrit 37 / 01 - UK : Closing date 30 Jun 2020
https://lymphoma-action.org.uk/trial/paradigme-phase-2-trial-comparing-two-different-doses-betalutin-and-lilotomab-people-relapsed
----------------------------------------------------
At det vil komme gode meldinger i 2019 er jeg overbevist om og her er et litt mer fra Internett.
ABG Sundal Collier har i følge Blomberg datart 3 oktober 2018 identifisert 24 mulige oppkjøpskandidater i 2019 hvor bla Nordiv Nanovecter er nevnt. Marlene jobbet her for noen år siden.......
Are you ready ? Biotech stocks provide a compelling opportunity for risk-tolerant investors looking for rich rewards. Regardless of market sentiment, economic data or trade wars, a key regulatory approval or trial data can send prices rocketing. Referanse to Madrigal Pharma (MDGL), which exploded by nearly 150% back in May following positive Phase 2 results for a liver-disease treatment.
Aug 03,2018 – Positive Scientific Opinion Under Early Access to Medicines Scheme will Make Patisiran Treatment Available for UK Patients, Before Marketing Authorization
Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration (FDA) accepted for review the company’s Biologics License Application (BLA) for fremanzumab for the treatment of migraine. The potential therapy was also granted fast track designation for the prevention of cluster headache.
Nordic Nanovecter kommer nok til å søke full godkjenning når resultatene fra Paradigme foreligger. Nordic Nanovecter har for flere år siden lagt en plan sammen med myndighetene i Storrbritania og hva denne planen innebærer fult ut har ikke ledelsen fortalt mye om, men hovedgrunnen er at medisinen skal nå pasientene snarest mulig
Her er linken for Paradigme - Lymrit 37 / 01 - UK : Closing date 30 Jun 2020
https://lymphoma-action.org.uk/trial/paradigme-phase-2-trial-comparing-two-different-doses-betalutin-and-lilotomab-people-relapsed
----------------------------------------------------
At det vil komme gode meldinger i 2019 er jeg overbevist om og her er et litt mer fra Internett.
ABG Sundal Collier har i følge Blomberg datart 3 oktober 2018 identifisert 24 mulige oppkjøpskandidater i 2019 hvor bla Nordiv Nanovecter er nevnt. Marlene jobbet her for noen år siden.......
Are you ready ? Biotech stocks provide a compelling opportunity for risk-tolerant investors looking for rich rewards. Regardless of market sentiment, economic data or trade wars, a key regulatory approval or trial data can send prices rocketing. Referanse to Madrigal Pharma (MDGL), which exploded by nearly 150% back in May following positive Phase 2 results for a liver-disease treatment.
Aug 03,2018 – Positive Scientific Opinion Under Early Access to Medicines Scheme will Make Patisiran Treatment Available for UK Patients, Before Marketing Authorization
Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration (FDA) accepted for review the company’s Biologics License Application (BLA) for fremanzumab for the treatment of migraine. The potential therapy was also granted fast track designation for the prevention of cluster headache.
Redigert 20.01.2021 kl 19:46
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Er finansiering på plass nok til at «enda et studie» kan gjennomføres til uti 2020, eller..?
Redigert 20.01.2021 kl 19:46
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trump_vinner
13.01.2019 kl 13:56
7001
Bra rente det ketle ;-)
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ketle homeowner
12.01.2019 kl 22:30
7334
Enig med deg - de må fullføre et studie først.
I tid samstemmer det med den tid Bravo antydet, midten av 2020.
"Men for all del, ting kan endres" ... nja... det er ikke så lett å fremskynde slike studier, endringer blir da gjerne heller utover i tid.
I tid samstemmer det med den tid Bravo antydet, midten av 2020.
"Men for all del, ting kan endres" ... nja... det er ikke så lett å fremskynde slike studier, endringer blir da gjerne heller utover i tid.
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Frontmasta
12.01.2019 kl 19:03
7493
Ledelsen i Nordic Nanovecter og MHRA og NICE jobber sammen om å få Betalutin på markedet snarest mulig. Dette innebærer at medisinen kan godkjennes på et tidlig tidspunkt, og da er det tidlig avklart både pris, behandlingssteder og hvordan forpakningen skal være - distrubiusjon mv.
Så kan man bestemme dosevalget. Deretter sendes søknad om fullstendig godkjenning
Ledelsen har enda ikke blitt tildelt PRIME om de har søkt vet ikke jeg, men de viste hvilke problemer BREXIT vil by på. Derfor er det full fres i England fortiden
Fra internett
US shutdown and Brexit
As 2019 begins, both the EMA and the FDA have got major headaches which could delay their drug approvals this year: The FDA is currently without long-term funding because of the US government shutdown, resulting from President Trump’s demands for money to build a border wall being blocked by Congress.
The EMA is also in the midst of the huge undertaking of relocating from London to Amsterdam, because of the UK’s exit from the EU.
https://www.nice.org.uk/about/what-we-do/life-sciences/office-for-market-access/early-access-to-medicines-scheme
Så kan man bestemme dosevalget. Deretter sendes søknad om fullstendig godkjenning
Ledelsen har enda ikke blitt tildelt PRIME om de har søkt vet ikke jeg, men de viste hvilke problemer BREXIT vil by på. Derfor er det full fres i England fortiden
Fra internett
US shutdown and Brexit
As 2019 begins, both the EMA and the FDA have got major headaches which could delay their drug approvals this year: The FDA is currently without long-term funding because of the US government shutdown, resulting from President Trump’s demands for money to build a border wall being blocked by Congress.
The EMA is also in the midst of the huge undertaking of relocating from London to Amsterdam, because of the UK’s exit from the EU.
https://www.nice.org.uk/about/what-we-do/life-sciences/office-for-market-access/early-access-to-medicines-scheme
Redigert 20.01.2021 kl 19:46
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TeeJay
12.01.2019 kl 05:50
7807
Nei vi er ikke der, de må fullføre ett studie etter å ha fått PIM, altså Paradigme.
De må ha ett solid datasett, og det har de ikke før Paradigme data begynner å materialisere seg.
Som Bravo sa, så kommer de ikke til å søke før midten av 2020.
Men for all del, ting kan endres
De må ha ett solid datasett, og det har de ikke før Paradigme data begynner å materialisere seg.
Som Bravo sa, så kommer de ikke til å søke før midten av 2020.
Men for all del, ting kan endres
Redigert 20.01.2021 kl 19:46
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Frontmasta
12.01.2019 kl 02:03
7867
Nordic Nanovecter gjør det MHRA forlanger, de har også ansatt ny mann i England fra 2 januar 2018, før å få fyr på lunta til raketten. Han slapp å søke på stillingen.
Link som viser at Nordic Nonovecter har registret " FREMDRIFTEN" som MHRA forlanger i rett database = Great Britain er med i denne databasesøknaden, se på ur llinken, hvor det står div bokstaver , som henviser til landene, hvis du skjønner hva jeg mener, hvis ikke så kan du kan bruke Google eller Rambler.ru for dette blir komplisert for meg med små briller, og liten skjerm. ....................Kjerringa lagte hummer i kveld slik den serveres i Marina di Cecina, og vin fra området
NÅ har Nordic Nanovecter faen meg meg oppdatet linken i går kveld, normalt foreresten for det skjer om fredagskveldene.Den forrige var fra 18 desember 2018
HVORFOR HAR NORDIC NANOVECTER DET VELDIG TRAVELT FORTIDEN I ENGLAND........................
http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2017-004506-18-NO
TOK DU ANN..............Ok ...............?
Link som viser at Nordic Nonovecter har registret " FREMDRIFTEN" som MHRA forlanger i rett database = Great Britain er med i denne databasesøknaden, se på ur llinken, hvor det står div bokstaver , som henviser til landene, hvis du skjønner hva jeg mener, hvis ikke så kan du kan bruke Google eller Rambler.ru for dette blir komplisert for meg med små briller, og liten skjerm. ....................Kjerringa lagte hummer i kveld slik den serveres i Marina di Cecina, og vin fra området
NÅ har Nordic Nanovecter faen meg meg oppdatet linken i går kveld, normalt foreresten for det skjer om fredagskveldene.Den forrige var fra 18 desember 2018
HVORFOR HAR NORDIC NANOVECTER DET VELDIG TRAVELT FORTIDEN I ENGLAND........................
http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2017-004506-18-NO
TOK DU ANN..............Ok ...............?
Redigert 20.01.2021 kl 19:46
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ketle homeowner
12.01.2019 kl 01:51
7883
Da ringer jeg deg. Vær beredt om et par timer.
Redigert 20.01.2021 kl 19:46
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Frontmasta
12.01.2019 kl 01:48
7888
Ketle.......1 karmøydaler er kursen på 1 kg hummer utfra dagens pris. Jeg har egne teiner, så jeg slipper å spørre Åkra sjømat i Åkra om dagens kurs, men da jeg var innom for noen dager siden svømte levende hummer og torsk i lokalene, og prisen var helt ok. Hvor mye Merck har betalt Arne Kolstad vet ikke Åkra sjømat men naboen min, og jeg vet beløpene.....
Hvis du søker på se.eiendom.no så finner du ut hva Jostein betalte for huset, etter han solgte aksjene, husk at du må logge inn med bank ID
Jostein måtte også betale andre utgifter som bla restskatt...........
TOG DU ANN.......... Hvis ikke så ring meg.
Hvis du søker på se.eiendom.no så finner du ut hva Jostein betalte for huset, etter han solgte aksjene, husk at du må logge inn med bank ID
Jostein måtte også betale andre utgifter som bla restskatt...........
TOG DU ANN.......... Hvis ikke så ring meg.
Redigert 20.01.2021 kl 19:46
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Sydney
12.01.2019 kl 01:38
7897
If a company receives a positive PIM designation, it will have to complete a clinical development programme before moving on to the second evaluation process..
Hva menes med dette og er vi der??
Hva menes med dette og er vi der??
Redigert 20.01.2021 kl 19:46
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ketle homeowner
12.01.2019 kl 01:36
7901
"Roche and BP must pay more "Karmøydalaer" for the patent to Jostein Dale"...
Frontmasta - kan det være dette som var bakgrunnen for at Jostein Dale solgte så mange aksjer etter forrige emisjon - han visste at han var verdig til å få "Karmøydalaer" ?
Hva er forresten kursen på en Karmøydalaer mot EUR og NOK pr. i dag ?
Frontmasta - kan det være dette som var bakgrunnen for at Jostein Dale solgte så mange aksjer etter forrige emisjon - han visste at han var verdig til å få "Karmøydalaer" ?
Hva er forresten kursen på en Karmøydalaer mot EUR og NOK pr. i dag ?
Redigert 20.01.2021 kl 19:46
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Frontmasta
12.01.2019 kl 00:40
7948
Roche pay grant for a PI from Arne Kolstad and Johanna Olweus in 2014. 100.000 Euro / 800.000 NOK
Time goes and values increase.
https://www.google.com/search?q=PI+together+w%2FArne+Kolstad%2C+(postdoc+grant+900.000%2Fyr.+2013-16)%3A&oq=PI+together+w%2FArne+Kolstad%2C+(postdoc+grant+900.000%2Fyr.+2013-16)%3A&aqs=chrome..69i57&sourceid=chrome&ie=UTF-8
PI together w / Arne Kolstad, postdoc grant 900.000 / from 2013 to 2016........................
Roche and BP must pay more "Karmøydalaer" for the patent to Jostein Dale and Nordic Nanovector, granted in january 2018.
DE STORE GJEDDENE KOMMER SNART
Time goes and values increase.
https://www.google.com/search?q=PI+together+w%2FArne+Kolstad%2C+(postdoc+grant+900.000%2Fyr.+2013-16)%3A&oq=PI+together+w%2FArne+Kolstad%2C+(postdoc+grant+900.000%2Fyr.+2013-16)%3A&aqs=chrome..69i57&sourceid=chrome&ie=UTF-8
PI together w / Arne Kolstad, postdoc grant 900.000 / from 2013 to 2016........................
Roche and BP must pay more "Karmøydalaer" for the patent to Jostein Dale and Nordic Nanovector, granted in january 2018.
DE STORE GJEDDENE KOMMER SNART
Redigert 20.01.2021 kl 19:46
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Frontmasta
11.01.2019 kl 20:37
8084
From Internett
A report found that EAMS did not offer a step (similar to one found in the FDA’s “Breakthrough Therapies Designation” which sends positive early signals to investors about promising new drugs. Therefore, an additional stage of EAMS, introduce a new Promising Innovative Medicine (PIM) designation was proposed and is now included in the scheme. ( Early Access to Medicines Scheme EAMS in the UK )
Steve Bates : By being a country where there is a speedy and effective way to develop medicines and the new types of data needed for adoption, this scheme can help ensure the UK continues to be the ‘go to location’ where companies from around the globe want to develop and bring to market their innovative therapies.
EAMS is a three-step voluntary evaluation process and is aimed at allowing access to therapies that have completed Phase III trials, but may be applied to those that have completed Phase II trials in exceptional circumstances. If data is really outstanding and there is a significant unmet medical need, the MHRA will be flexible and assess Phase II data but companies have to provide solid data to demonstrate risk versus benefit of the therapy. When a positive PIM designation is obtained, applicants can then proceed to step II and Step III, the EAMS Scientific Opinion, where
the MHRA aims to be both fast and flexible and complete its opinion in 75 to 90 days. Step II is a pre-submission meeting with MHRA to ensure that your product is suitable for an EAMS scientific opinion application.
If a company receives a positive PIM designation, it will have to complete a clinical development programme before moving on to the second evaluation process – the EAMS scientific opinion assessment. In addition to having a PIM designation, companies applying for an EAMS scientific opinion must also attend a pre-submission meeting with the MHRA. The purpose of this meeting is to evaluate whether the suitability criteria for the scheme are likely to be met and explain the format of the data required to be submitted to support the MHRA’s benefit/risk opinion. Based on the outcome of this meeting, the MHRA will either designate the product a suitable candidate for the EAMS scientific opinion, or will reject the product and terminate the application process.
A positive PIM designation will signal to investors that a therapy is on the 'right track' with the regulators.
4 januar 2019 :
It’s great to see that Nordic Nanovector insiders own 2.6% of the company. I like to see this level of insider ownership, because it increases the chances that management are thinking about the best interests of shareholders.
Frem til gladmeldingene kommer vil de små gjeddene kjøpe og selge aksjer hver dag, og så poster de her hos Trygve hver javla dag hvor flinke de er.
Få heller frem noe med substans folkens.................................................. På forhand takk !
A report found that EAMS did not offer a step (similar to one found in the FDA’s “Breakthrough Therapies Designation” which sends positive early signals to investors about promising new drugs. Therefore, an additional stage of EAMS, introduce a new Promising Innovative Medicine (PIM) designation was proposed and is now included in the scheme. ( Early Access to Medicines Scheme EAMS in the UK )
Steve Bates : By being a country where there is a speedy and effective way to develop medicines and the new types of data needed for adoption, this scheme can help ensure the UK continues to be the ‘go to location’ where companies from around the globe want to develop and bring to market their innovative therapies.
EAMS is a three-step voluntary evaluation process and is aimed at allowing access to therapies that have completed Phase III trials, but may be applied to those that have completed Phase II trials in exceptional circumstances. If data is really outstanding and there is a significant unmet medical need, the MHRA will be flexible and assess Phase II data but companies have to provide solid data to demonstrate risk versus benefit of the therapy. When a positive PIM designation is obtained, applicants can then proceed to step II and Step III, the EAMS Scientific Opinion, where
the MHRA aims to be both fast and flexible and complete its opinion in 75 to 90 days. Step II is a pre-submission meeting with MHRA to ensure that your product is suitable for an EAMS scientific opinion application.
If a company receives a positive PIM designation, it will have to complete a clinical development programme before moving on to the second evaluation process – the EAMS scientific opinion assessment. In addition to having a PIM designation, companies applying for an EAMS scientific opinion must also attend a pre-submission meeting with the MHRA. The purpose of this meeting is to evaluate whether the suitability criteria for the scheme are likely to be met and explain the format of the data required to be submitted to support the MHRA’s benefit/risk opinion. Based on the outcome of this meeting, the MHRA will either designate the product a suitable candidate for the EAMS scientific opinion, or will reject the product and terminate the application process.
A positive PIM designation will signal to investors that a therapy is on the 'right track' with the regulators.
4 januar 2019 :
It’s great to see that Nordic Nanovector insiders own 2.6% of the company. I like to see this level of insider ownership, because it increases the chances that management are thinking about the best interests of shareholders.
Frem til gladmeldingene kommer vil de små gjeddene kjøpe og selge aksjer hver dag, og så poster de her hos Trygve hver javla dag hvor flinke de er.
Få heller frem noe med substans folkens.................................................. På forhand takk !
Redigert 20.01.2021 kl 19:46
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Frontmasta
09.01.2019 kl 23:59
8596
Nordic Nonovecter skal snart til Barcelona / Bioequity europe 2019 og forklare investorene at de har utvidet produksjonslokalene og snart er vel Betalutin klar .....
https://www.biocentury.com/articles?rsid=8ff318c1-1ffa-4847-bf0e-e0370d7f99d9
BLA for Nordic Nanovecter................in 2019 ?
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
Oslo, Norway, 12 June 2018
Nordic Nanovector ASA (OSE: NANO) announces that the US Food & Drug Administration (FDA) has granted Fast Track designation to Betalutin® (177Lu-lilotomab satetraxetan) for the treatment of patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies.
Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. The designation provides the opportunity for more frequent meetings with the FDA over the course of drug development. In addition, the Fast Track programme allows for Rolling Review, which enables a company to submit individual sections of its Biologic License Application (BLA) for review as they are ready, rather than waiting until all sections of the BLA are complete, as well as for eligibility for Accelerated Approval and Priority Review if relevant criteria are met.
https://www.biocentury.com/articles?rsid=8ff318c1-1ffa-4847-bf0e-e0370d7f99d9
BLA for Nordic Nanovecter................in 2019 ?
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
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.
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.
Redigert 20.01.2021 kl 19:46
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SHARE-IT
09.01.2019 kl 22:37
8770
Jeg legger for egen del stor vekt på de ansettelser NANO har gjort den senere tid. Det tyder jo åpenbart på at alt eller i alle fall det meste går som ønsket eller forventet om enn TTT også for NANO. BP følger åpenbart med NANO og med ytterligere bekreftelser på virkningen av Betalutin tror jeg det ikke tar lang tid før de er på banen og vil kjøpe eller samarbeide. Men må NANO støtte seg på BP? Kanskje for å oppnå raskere og stor markedstilgang, ved produktsuksess. Signalene går jo også mot at de ønsket å greie seg alene .... . Spennende er det.
Redigert 20.01.2021 kl 19:46
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