Genmab — Marts 2020

[Monforte]

Sidder her i Vejle og er i gang med den 75. sekvens af DARA. Læste lige det link som EL 08:32 henviste til om subkutan vs IV. Som jeg lytter mig frem til vil tiden for subkutan være præmedicin 30 min + subkutan 5 min + observation 20 min, så ca en time mod 2,5-3 timerfor IV.

[JKY_VH]

Super, tak og tlk med "jubilæet". Dara er et fantastisk præparat:-)

[E_L]

Nice @Monforte ! Is it still Dara mono? Do you currently still need to get pre-medication before your IV?

[Monforte]

It is still DARA-mono! And I get Pre-med 30 min before IV and saltwater 30 min after ( the observation time)

[Monforte]

And still no signs of the m-component

[E_L]

Nice to hear some good news these days!

[E_L]

EMA agenda this week, Day 180 list of
outstanding issues: 4.2.1. Darzalex - daratumumab - Orphan - Scope: “Extension application to introduce a new pharmaceutical form (solution for
injection), a new strength (1800 mg) and a new route of administration (subcutaneous
route).”
Action: For adoption

[Bulder]

So we can expect a chmp-recommendation on Friday?

[E_L]

i don't think so, probably more questions for JNJ
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/evaluation-medicines-step-step -but i would be happy to be wrong here...

[Bulder]

I see, theoretically it could be over now, if ema doesn't have further Q. But else 1 mth clock stop 2 and another 30 days until 210 days.

[E_L]

yes, i hope it doesn't get delayed with all that is happening right now. But i assume EMA people can easily do all of this from home

[Plimsoller]

God morgen

[Helge_LarsenPI-redaktør]

God morgen.

[E_L]

From Novartis: At this time, we do not anticipate any delays to regulatory submissions.
 Upcoming launches of ofatumumab, capmatinib, inclisiran all filed with respective health authorities.
Pre-launch activities continue as planned.
 Ofatumumab is manufactured in Switzerland https://www.novartis.com/sites/www.novartis.com/files/novartis-frequently-asked-questions-covid-19.pdf

[Sukkeralf]

Nice E L

[Sukkeralf]

The most problematic in my opinion is Genmabs CD20/CD3 - if it gets delayed due to hard times starting new clinical trials. Maybe even more important now to get a partner deal and BP on board. They can spend time planning and stuff while the Corona virus slow things down

[E_L]

yes, not easy to close a deal though when you can't meet anyone i imagine.. ideally you don't do this over the phone... cross fingers...

[E_L]

are we expecting anything from Symphony Health
today?

[bibob]

Yes E L. - Maybe silende.

[bibob]

Silence