Noe for Stock DZ?
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Hi Investor1, Jeg synes det er et overtramp at du bruker PW sitt bilde for ditt profilbilde.
Medlem fra 10 november 2016 ser jeg, Hallo Per! 
Fortsett slik, du er dyktig!
Var et forsøk på humor, håper det ble bedre nå.
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@Don_suger On my late summer vacation, limited internet access to do more research, it s not like I don’t want to 
will be back!
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Overtramp er litt sterkt ord for meg, men ja det er kanskje ikke det smarteste. Ser gjerne at @pdx lager en policy på om det er ok eller ikke
Best å ha et unikt og eget profilbilde ja 
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Radfork på plass på arendalsuka, mulig pcib blir nevnt, jeg skal iallefall tune inn kl 2😊
Ingen som er i området som kan stikke innom? Sikkert muligheter for å låne Jónas Einarsson Litt etterpå
Arrangør
RADFORSK, Kreftforeningen
Dag
Tirsdag 14/8 2018 14:00 - 16:00
Arrangementstype
Debatt
Tema
Helse , Innovasjon
Språk
Norsk
Sted
MØR biffhus
Stedsbeskrivelse:
Rådstua
Om arrangementet
Regjeringen jobber med en ny Stortingsmelding om helsenæring. Dette er en næring som kjennetegnes av høy profitt og at den løser en av de største utfordringene vi mennesker har: Vi blir alle syke.
Norge bruker i snitt 65.000 kroner per innbygger på helse i året. Det er store summer å spare på å utvikle bedre helsetjenester, samtidig som det er store summer å tjene på å utvikle bedre helsetjenester.
Norge investerer årlig ni milliarder i helseforskning. Vi har kompetetente miljøer som utvikler bedre behandling: Men vi kan så mye mer. Hvorfor ikke bare satse slik vi gjorde med oljen på 1970-tallet og ta en ledende posisjon innen helsedata, kreft, neurologiske sykdommer og andre områder der vi er i verdenstoppen?
Medvirkende
Jónas Einarsson, Administrerende direktør, RADFORSK
Elisabeth Kirkeng Andersen, Kommunikasjonsansvarlig, RADFORSK
Anne Lise Ryel, Generalsekretær, Kreftforeningen
Ketil Widerberg, Daglig leder, Oslo Cancer Cluster
Ruth Grung, Stortingsrepresentant, Arbeiderpartiet
Ole Erik Almlid, Viseadministrerende direktør, NHO
Andreas Stensvold, Avdelingssjef kreftavdelingen, Sykehuset Østfold
Øyvind Kongstun Arnesen, Administrerende direktør, Ultimovacs AS, styreleder Oslo Cancer Cluster
Torill Eidsheim, Stortingsrepresentant, Høyre
Kontaktperson:
Elisabeth Andersen, Kommunikasjonsansvarlig, RADFORSK, 40492104, [email protected]
Nettside:
http://www.radforsk.no, http://www.kreftforeningen.no
Facebook:
www.facebook.com/radforsk/
Twitter:
@radforsk
Universell utforming
Rullestoltilpasset lokale
Rullestoltilpasset WC
Streaming https://twitter.com/radforsk
Servering
Ja
Sidevisninger
537
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Hi
Somehow managed to pull this one out 
This is related to ODD from EMA, link below go to page 27
Committee for Orphan Medicinal Products (COMP)
Minutes for the meeting on 11-13 July 2016
http://www.ema.europa.eu/docs/en_GB/document_library/Minutes/2016/09/WC500213115.pdf
I am just trying to do the math here: read this in page 27
“
2.2.17. Fimaporfin (in combination with gemcitabine) - EMA/OD/111/16
PCI Biotech AS;
Treatment of cholangiocarcinoma
COMP coordinator: Katerina Kopečková/Dinko Vitezic
The Committee agreed that the condition, cholangiocarcinoma, is a distinct medical entity and meets the criteria for orphan designation.
The intention to treat the condition with the medicinal product containing fimaporfin was considered justified based on clinical data in patients who achieved stable disease, partial responses and improved survival.
The condition is life-threatening and chronically debilitating due to biliary obstruction, late diagnosis and a median survival of less than 24 months.
The condition was estimated to be affecting less than 1.3 in 10,000 persons in the European Union, at the time the application was made.
The sponsor has also established that there exists no satisfactory method of treatment that has been authorised in the European Union for patients affected by the condition.
A positive opinion for fimaporfin, for treatment of cholangiocarcinoma, was adopted by consensus”
Assuming population in European Union is > 500 million, this gives approx 65000 people affected per year??? Why did they use 1.3 where they could have just said less than 5 per 10000 (which is a condition for ODD)
Is the market for fimachem bigger than we think in Europe, remember this is EMA, so who know better than them ???
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If you read in the same report about other ODD applications as example you can see that some are less than 0,01 or 0,1 or 1 or 3,3 … etc per 10000 in our case is less than 1,3 per 10000. So this number must have a background behind not just arbitrary number
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Good digging! The European population as per today is actually 742 millions. This then mean we are talking about 96.460 patients…
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They say European Union not European
512 million in 2018
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But why do pcib inform the market that we are dealing with 3000 patients? Are those numbers only based on US?
But who controls the areas outside EU? There are still over 200 million people outside the union and how do they get access to such products?
From Q1 presentation:
“Orphan indication, yearly incidence rate of 1-2 per 100,000 in the western world – higher in Asia”
1 Like
Mulig det er før det trekkes ifra de pasientene som i utgangspunktet ikke skal være med? Tenker da f.eks. at de targeter de som er inoperable og de med perihilar tumors. Kan også være at antallet går på totalt antall personer som har sykdommen nå og ikke hvorr mange pasienter pr. år som får det. Det hvil ihvertfall kunne senke antallet en god del. Likevel så vil jeg nok anta at Per Walday som i stort sett alt han sier er veldig konservativ har nok sørget for å heller gå i den lavre delen av skalaen når han informerer.
Det tyder også på at dersom de skulle bli brukt offlabel på andre gallegangskreft typer at potensialet fort kan være vesentlig høyere.
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Seems that EMA (COMP) uses prevalence rate in ODD applications rather than incidence rate, then the numbers make sense and we should stick to pci biotech guiding. In the link below page 2 you ll find how EMA calculate/define the prevalence rate
Prevalence is traditionally defined as the number of persons with a disease or condition at a specified instant in time in a given population. It is sometimes referred to as ‘point prevalence’ and expressed as a proportion.
The ‘prevalence criterion’, which is described in article 3 (1) (a) of Regulation (EC) No 141/2000, requires the demonstration through authoritative references that the disease or condition for which the medicinal product is intended, affects not more than 5 in 10,000 persons in the Community, when the application is made. Therefore, in the context of the orphan legislation the prevalence refers to the number of persons with the condition at the time the application is made, divided by the population of the Community at that time. In the application for designation, prevalence should be expressed as the proportion of persons affected by the condition, per 10,000. For instance, with an estimated population in the Community of 377.6 million (as of 1 January 2001) a total of 188,800 persons correspond to a prevalence of 5 in 10,000.
For the purpose of establishing the ‘prevalence criterion’, prevalence is expressed as a proportion, and the population at risk (the denominator) should always refer to the entire population of the Community even if the population at risk of the condition is just a subset of the entire general population (e.g., ovarian cancer in women, idiopathic respiratory distress syndrome in premature newborns).
For conditions of average duration of less than one year, prevalence data should be complemented with yearly incidence data (relevant to the year of submission of the application) and the sponsor should establish that the condition affected less than 5 per 10,000 persons during the year when the application was submitted.
In many situations, the true prevalence at the time of application will not be known and the demonstration of the ‘prevalence criterion’ will be based on the estimated prevalence of the condition at a certain point in time. Where this is the case, there should be reasonable evidence that the estimate provided is a good approximation of the true prevalence of the claimed orphan condition in the European Union, at the time of application.
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Bad news for profit hunters, but good news for patients 
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This is good to read about incidence rate
https://www.nature.com/articles/nrgastro.2016.51/figures/1#f1
1 Like
One of the best papers about CCA with incidence rates…etc
Cholangiocarcinoma: current knowledge and future perspectives consensus statement from the European Network for the Study of Cholangiocarcinoma (ENS-CCA)
https://www.nature.com/articles/nrgastro.2016.51.pdf
If you don’t like pdf you can find it in this link
4 Likes