Genmab — Maj 2021

[E_L]

my gutfeel is that most epco response also are CMR, but if not ALL of them are, or if the trial criteria were not CMR they can not call it that

[E_L]

disclaimer; i am NOT a doctor

[lahn1]

Generelt, hvis man er på EMA’s agenda f.eks i denne uge/md. hvornår kan man så regne med at høre nyt når det handler om godkendelse eller ej ?

[Bulder]

Svært at sige. Sagen kan godt være på CHMP's dagsorden, uden at der bliver besluttet noget. Måske sender de sagen videre til PRAC (safety). Og så kan der gå lang tid.

[Bulder]

Men hvis sagen HAR været i PRAC, så kan det ske når som helst. De udsender hver fredag en meddelelse om hvilke stoffer, der er blevet godkendt/afvist.

[Bulder]

Vi har gennem tiden adskillige gange set dara på dagsordenen, men hvor der ikke er besluttet noget. Blot at sagsbehandlingen går videre.

[E_L]

On 20 May 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted two positive opinions recommending changes to the terms of the marketing authorisation for the medicinal product Darzalex
https://www.ema.europa.eu/en/medicines/human/summaries-opinion/darzalex-2

[Bulder]

So in a couple of weeks the EU comission will take the final, formal descision.

[Bulder]

Sometimes Genmab sends out messages, when CHMP recommends positive.

[E_L]

Amyloidosis
application was early november, pretty fast

[lahn1]

Tak Bulder

[peter12]

Bulder jeg tror CR er et RECIST kriterie og CMR et PET-CT men ellers ved jeg ikke

[Bulder]

Nederst i denne artikel står at recist-kriterier ikke kan bruges til lymfomer https://pri.rn.dk/Sider/19237.aspx

[E_L]

here is your release @Bulder . I was told they made it specially for you. https://ir.genmab.com/news-releases/news-release-details/genmab-announces-janssen-has-received-positive-chmp-opinion

[Bulder]

In the "old" days you could have these messages in your mail-box. What happenned to that arrangement?

[Helge_LarsenPI-redaktør]

Just a moment...

(www.proinvestor.com)

[E_L]

15:23 for me, but it had to travel further all the way to NL!

[Bulder]

Hvor har I meldt jer til? Jeg fik dem også førhen. Men pludselig holdt det op.

[E_L]

you did ask Jan some very difficult questions in the Q&A Bulder ; was that when the emails stopped ?

[Bulder]

Det lyder sandsynligt Mails er ikke for fattigrøve