Genmab — Januar 2021

[Klarussen]

Godmorgen @SEACOP: ved ikke hvordan den beregning er foretaget, men ingen protester herfra hvis det skulle blive aktuelt

[bibob]

Light- chain AL worldwide. https://storage.pardot.com/84702/176981/Zhang_N._Estimating_the_global_epidemiology_of_Amyloid_light_chain_Amyloidosis_wit.pptx

[E_L]

this approval was very fast, specially if you consider the pandemic... 'The FDA approved this application 7 weeks ahead of the FDA goal date.' https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-darzalex-faspro-newly-diagnosed-light-chain-amyloidosis

[Legolas23]

IT was also RTOR

[Klarussen]

Ja, der er fart på:
Purpose of the RTOR Pilot
The Oncology Center of Excellence Real-Time Oncology Review (RTOR) pilot program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible, while maintaining and improving review quality and balancing the review team’s workload through data and analysis standardization, and early iterative engagement with the applicant.

[E_L]

yes. Just like Amivantamab.

[Darvin]

Karussen 08.37 ganske enkelt. De 5.749 er hvis alle daværende udviklingsprogrammer lykkes. Indtil videre går det jo ganske godt

[Klarussen]

"Knock your socks off"

[Klarussen]

Vi kan kun håbe EMA er ligeså hurtige. Der blev ansøgningen sendt i november
(oktober til FDA)

[royal]

Nok ikke alt vil lykkes og når noget ikke lykkes kommer der ofte en overreaktion.

[Helge_LarsenPI-redaktør]

ØU i dag: "Genmab går mod nye højder i det nye år. Der er linet op til et kapløb mellem Genmab og Roche indenfor de bi-specifikke antistof-fer i NHL. Efter lidt konsolidering omkring det nuværende kursleje virker aktien nu klar til at bevæge sig op i nye højder i det nye år". ...

[Helge_LarsenPI-redaktør]

Nyheden fra i går aftes er i sagens natur ikke med i David Myginds artikel.

[Helge_LarsenPI-redaktør]

David skriver skriver dog, at de fantastiske ANDROMEDA-data, der blev fremlagt på ASH underbygger ræsonnementet, at lanceringssandsynligheden i AL er 100 procent. Det fik han så ret i.

[Helge_LarsenPI-redaktør]

Han forventer, at amy-loidosis-salget bliver 200 mio. USD.

[E_L]

in the first quarter?

[E_L]

TEPEZZA Short-Term Supply Disruption FAQ https://www.horizontherapeutics.com/media-center/horizon-resources/tepezza-short-term-supply-disruption-faq

[Stroka]

Medwatch: https://medwatch.dk/Medicinal___Biotek/article12693645.ece

[Helge_LarsenPI-redaktør]

E L. Unfortunately not the first quarter. That is the top sales estimate.

[E_L]

I was joking offcourse, but I think that is significantly too low. I think we can breach $400mio this year already.

[E_L]

Dara is fully established, it is not a new drug, most MD’s will already have had experience with it and a lot of them even with SC. You can see from the numerous twitter reactions how enthusiastic most MD’s are. It is the first and only therapy and It will go straight to first line.