Genmab — Januar 2019

[peter12]

Portugal har godkendt dara ? https://translate.google.com/translate?sl=pt&tl=da&u=http%3A
%2F%2Fviglya.com%2Finfarmed-novo-medicamento-para-tratamento-em-doentes-oncologicos-darzalex-daratumumab-avaliacao-previa-hospitalar-concluida%2F

[peter12]

Sorry http://viglya.com/infarmed-novo-medicamento-para-tratamento-em-doentes-oncologicos-darzalex-daratumumab-avaliacao-previa-hospitalar-concluida/

[E_L]

JNJ looking to remove QTc prolongation from the Risk Management Plan for Dara on the next EMA PRAC meeting:

[E_L]

"
Scope: Submission of study report of study SMM2001: a randomised phase 2 trial to evaluate 3 daratumumab dose schedules in smouldering multiple myeloma. As a consequence, the RMP is updated (version 4.1) in order to remove QTc prolongation as an important potential risk"

[E_L]

SMM2001 is Centaurus

[Raun]

JV: 14.39..... Skal jeg forstå det sådan at vi er enige omkring at "gribbene" kan styre aktien på nuværende tidspunkt.... - Og i givet fald. - Hvad skal der efter din mening til, for at "gribbene" holder sig væk!?

[jkj]

[Bulder]

thx E L. Didn't know that QTc pro was considered a potential risk.

[polle1]

jkj : Nu kan man jo ikke lave en "tommel op" her i chatten, men hvis man kunne, havde du fået én,

[polle1]

[bibob]

Bulder. hvad betyder det helt nøjagtigt. er der problemer med Centaurus studiet. ??

[E_L]

@bibob QTc prolongation is currently one of the risk mentioned on the leaflet for Dara (see II.A here https://www.ema.europa.eu/documents/rmp-summary/darzalex-epar-risk-management-plan-summary_en.pdf
)

[E_L]

i imagine that, whenever JNJ can get one of those risks of that list, they will ask EMA to do this.

[E_L]

I understand the agenda item to mean, that are trying to remove this risk from the RMP based on findings in the Centaurus study (so that is positive findings)

[Bulder]

OK. It was considered a potential risk, not an identified risk. But of course nice to have it removed.

[Bulder]

Godt nok længe siden, vi har haft så lav omsætning.

[bibob]

Thx E L.

[Skod]

"...hvad pipelinen indeholder er en helt anden diskussion - jeg påpeger blot, at dara-værdien ikke bliver afspejlet i kursen - og at pipelinen (I min optik) bliver handlet til negativ værdi"

[Skod]

Det er jeg s[dan set helt enig i. Er det ikke netop det der gør Genmab så interessant?

[Skod]

Man betaler for Dara (det meste i hvert fald) og får pipen gratis, eller mener du det er fair at pipen handles til negativ værdi?