Genmab — Januar 2019

[bibob]

Så må vi jo bare håbe at det kan nåes ( såfremt der er søgt )

[Plimsoller]

Helt enig, og det er da bestemt ikke umuligt. Nedlukning eller ej, så regner man vel med at der ville være nyheder angående ansøgningsformen indenfor 3 uger alligevel?

[transalp]

Go morgen:)

[polle1]

God morgen

[E_L]

Rajkumar mentioning Dara in PGNMID
https://twitter.com/VincentRK/status/1085400163106123776 which is this trial https://clinicaltrials.gov/ct2/show/NCT03095118

[bibob]

Small study, but could be important . " There are no known standard effective treatments for patients with PGNMID "

[Teller]

Hvis FDA er gået i stå med godkendelsen af MAIA (er dette helt konkret blevet udtalt?), så betyder det vel at vi er under RTOR. Ellers ville de vel knapt være igang da der vel under normal godkendelses procedure er lidt ventetid.

[E_L]

Scott Gottlieb on PDUFA - We’ll get into February but how far into Feb is still very fluid https://twitter.com/SGottliebFDA/status/1085317226150969344

[Plimsoller]

Yes. Almost the same as in Børsen E L. So we can expect them to run out of money between 3-5 weeks including this week. That will hopefully leave enough time for the approval of 1.st line Darzalex or the budget.

[Solsen]

It will be close if RTOR is accepted.

[Plimsoller]

Yes Solsen, but also quite a potential upside if it happens, now that we have this shutdown to take into consideration.

[bibob]

I think that the guiding for 2019 wil be better if that happens. And we need a trustable good guiding.

[Bulder]

Anyways, it will be easier for them. In stead of a broad guidance from 3 to 3,5, they can narrow it from 3,3 to 3,5 bn.

[bibob]

Yes,- it would be a very nice guiding. Make it happen

[pauly]

Er der ikke lidt hysteri omkring denne nedlukning, herre gud en lille forsinkelse klarer vi nok

[JKY_VH]

Ja, vi klarer det nok pauly, men markedet:-)

[Helge_LarsenPI-redaktør]

Forsinkelsen er værst for patienterne.

[JKY_VH]

ja naturligvis.

[Sukkeralf]

301 Moved Permanently

(adctherapeutics.com)

[Helge_LarsenPI-redaktør]

Lægemiddelstyrelsen var på inspektion i dag på familiens fabrik og lager i Kvanløse. Vort nye medicinlager, GDP kvalitetsstyring-system samt dokumentation bestod trykprøvningen. En stor tak til Cand. Pharm Lone Jespersen - tidligere QA hos Genmab - for bistand med skemaer og dokumenter.