Dekker dette bare EU eller US også?
Desperat opptakt til en emisjon, tenker jeg vi sier. Fint å skremme liv i den gamle tanta når emisjonen presser seg stadig nærmere.
Blir ikke poppis av å skrive slikt, men husk hboe du leste det først 
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Så du mener de valgte å få denne tilbakemeldingen fra EMA akkurat nå pga de planlegger emisjon…? Nyhetsflowen fra EMA er jo ikke noe de styrer selv akkurat, så at dette er et ledd i så måte tror jeg ingenting på!
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Når kan vi forvente mer archerdata?
Hvis det kommer en emisjon etterhvert så er det helt ok Da fortsetter Archer, og vi kan få MZL nærmere markedet.
Alernativet er at man kan forhandle frem en avtale med BP med enda et ess i ermet.
Jeg ser ikke problemet.
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Smeller ikke denne opp minimum 20% fra start forstår jeg ingenting!!
Champagnen sprettes:ok_hand:
« We look forward to receiving the final decision by the European Commission in the coming weeks
Denne alene løfter Nano om par dager 30NOK
Skal det lykkes en Biotec selskap i Norge etter Algeta så blir det NANO
In the LYMRIT 37-01 Phase 1/2a trial, Betalutin® showed a highly encouraging 78% overall response rate (ORR) and 44% complete response (CR) in the MZL patient group (n=9) - the highest response rates of any patient sub-population in this study. This followed a once-only administration of Betalutin® in this heavily pre-treated group of patients with advanced disease.Gratulere folkens Nano skal lykkes.Fra E24. Nordic Nanovector nærmer seg ny EU-godkjennelse
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MEN dette!?:
“Phosphoinositide 3-kinase (PI3K) inhibitors have shown excellent activity in iNHL, specifically in MZL, with breakthrough designation status for copanlisib and umbralisib, allowing off label use of this class of agents in clinical practice.”
Kan man bruke medisin off-label etter en BTD??? Om Betalutin får en BTD innen MZL etterhvert betyr vel det at det kan brukes i denne indikasjonen off-label etter en evnt godkjent paradigme-studie…?
( “with breakthrough designation status for copanlisib and umbralisib, allowing off label use of this class of agents in clinical practice.”)
Copanlisib mottok BTD basert på 23 pax. 78 % ORR og 13 % CR…
Objective responses by independent assessment were observed in 18 patients (ORR 78%) and CRs in 3 patients (13%); ORRs were 50% (2/4 patients) in MALT MZL, 87% (13/15 patients) in nodal MZL and 75% (3/4 patients) in splenic MZL.
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Forstår ikke helt hvorfor alle bekymrer seg stadig over emisjoner i bioteknologiselskaper. De har ikke inntekter, emisjoner er helt naturlig for videre utvikling. Alternativet er at det ikke er progresjon og null verdi til slutt.
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Hva er ODD og hvordan påvirker det nano? Forstår det slik at det er forbeholdt behandlinger som ellers ikke ville være lønnsomme på grunn av sjeldne sykdommer og lave pasientantall. Derav lengre perioder med ekslusive rettigheter etc. Er ikke helt oppdatert, men inngår mzl i paradigme?
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Designated orphan medicines are eligible for conditional marketing authorisation. In some cases, designated orphan medicines may be allowed to be administered to patients under compassionate use, a treatment option that allows the use of an unauthorised medicine outside a clinical study.
Inntektene kan komme fortere enn vi aner 
Lenger ned på linken
The Agency encourages companies developing orphan medicines to check if they can be classified as a micro, small or medium-sized enterprise (SME) . Such companies benefit from further incentives, including administrative and procedural assistance from the Agency’s SME office and fee reductions
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Orphan medicinal product designation
Positive opinions
The COMP adopted 12 positive opinions recommending the following medicines for designation as orphan medicinal products to the European Commission:
- Opinions adopted at the second COMP discussion, following the sponsor’s response to the COMP list of questions:
• Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains for treatment of multiple myeloma, FGK Representative Service GmbH;
• Lutetium (177Lu) lilotomab satetraxetan for treatment of marginal zone lymphoma, Nordic Nanovector ASA;
• Methotrexate for treatment of retinal detachment, Helio Vision Germany GmbH. - Opinions adopted at the first COMP discussion:
• (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acidhydrogen chloride(1/1)) for treatment of paroxysmal nocturnal haemoglobinuria, Novartis Europharm Limited;
• 1-((2S,4S)-2-((((S)-(4-bromophenoxy)(((S)-1-oxo-1-(((S)-pentan-2-yl)oxy)propan-2yl)amino)phosphoryl)oxy)methyl)-1,3-dioxolan-4-yl)-2-oxo-1,2-dihydropyrimidin-4-aminium chloride for treatment of hepatocellular carcinoma, Medivir AB;
Committee for Orphan Medicinal Products (COMP) meeting report on the review of applications for orphan designation
EMA/COMP/230411/2020 Page 2/7 Classified as public by the European Medicines Agency
• Adeno-associated virus serotype 9 containing the human ASPA gene for treatment of Canavan disease, Raremoon Consulting Limited;
• Autologous CD4+ and CD8+ T cells transduced with a lentiviral vector encoding an affinity enhanced T cell receptor specific to MAGE-A4 for treatment of soft tissue sarcoma, Adaptimmune Limited;
• Ile-Ala-Leu-Ile-Leu-Glu-Pro-Ile-Cys-Cys-Gln-Glu-Arg-Ala-Ala-(discrete-polyethylene glycol)24 for treatment of neonatal encephalopathy, Clinipace GmbH;
• Lumacaftor for treatment of non-traumatic aneurysmal subarachnoid haemorrhage, Qanatpharma GmbH;
• Rilzabrutinib for treatment of immune thrombocytopenia, Clinical Network Services (NL) B.V.; • Sodium phenylbutyrate, tauroursodeoxycholic acid for treatment of amyotrophic lateral sclerosis, Drug Development and Regulation S.L.;
• Viltolarsen for treatment of Duchenne muscular dystrophy, Medpace Finland Oy.
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Hva tenker dere?
Nano setter vel ikke i gang et nytt pivotal studie før Paradigme er i boks og 15/40 eller 20/100 dilemmaet er avklart?
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Noen som har en formening om hvorfor Lars fortsatt er interim CEO?
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Ikke godt å si, men mye kan jo skje her de neste månedene om interim passeres ila juni. Håper jo nesten at de ikke gjør for store endringer i Paradigme, parkerer en av armene og dermed går for AA.
Tror det må godkjennes på generalforsamling.
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Paradigme utvides med en mzl-arm el.l.
Det er jo fordi de vet at de blir kjøpt opp av BP snart og dermed trenger de ingen permanent CEO
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