Genmab — November 2018

[gentogen]

Ifølge vejledningen fra FDA skal de først søge om det og derefter indsende en foreløbig ansøgning, der så kan blive til en ansøgning. Jeg tvivler lidt på, at de oplyser noget før en eventuel egentlig ansøgning er indsendt, hvilket ifølge standardplanen er ved cirka uge 16

[gentogen]

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm612927.htm#ROTR_FAQ_s

[E_L]

and from what date are you counting? October 29?

[Bulder]

According to the timeframe request for RTOR is submitted at the time of top line data. Should have been done long time ago After 4 weeks initial RTOR-meting with OCE. This is next monday. Exactly timed with the R&D-day.

[Bulder]

Well, not nescessarily on Monday, but the week starting with Monday.

[Sukkeralf]

Not that good comment in twitter link: I’d wager this doesn’t translate into Dara-based combinations dominating community practices in the US

[Sukkeralf]

Lets bet and hope Jan is right !!

[E_L]

comments like that are exactly why i wrote last week "but given this discussion, i now realise how important it will be to have the late breaker, to explain and discuss with MD's (i thought with this data it would have been a slam dunk"

[E_L]

the only disadvantage is that the late breaker is on the last day…

[Sukkeralf]

Yes and such a big difference between Jans expectations of capturing 50% of the market quite quick

[peter12]

@Sukker 13:22 Kommentaren er til D-VMP ? Som vist ikke bruges i US ?

[E_L]

i forwarded those Rajkumar comments from last week or so to Rachel, I am sure they are familiar with this discussion. I mean, at the end of the day they can not force anyone to use Dara, but they can debate the benefits and sell it strongly this weekend. I am sure JNJ will do its part.

[E_L]

Good News Is on the Way for Blood Cancer Patients - Barrons - https://www.barrons.com/articles/good-news-is-on-the-way-for-blood-cancer-patients-1543581000

[E_L]

Citi said that while bears may point to competitive threats from BCMA and CAR-T therapies, Darzalex is likely to be the “dance/combination partner of choice.” - via Bloomberg - https://www.bloomberg.com/news/articles/2018-11-29/drugmakers-set-for-multiple-myeloma-showdown-at-hematology-event

[Bulder]

Ja. kommentaren er til D-VMp og som sådan ikke overraskende. det vidste vi i forvejen. Men han siger "combinationS" i flertal. Det eneste der måske kunne tyde på at han mener, i det hele taget.

[Bulder]

Men man skal være endog meget skeptisk for at udlægge kommentaren negativt for D-Rd.

[Darvin]

Maybe the Dancing Queen

[bibob]

God weekend til alle. Psykologisk tror jeg det er vigtigt at ugen slutter over kurs 1000. Der er en meget vigtig konference i USA ( ASH ) som helt sikkert vil give nogle svar på mange spørgsmål ift . MAIA . Hvis G20 også kommer med lidt positivt vil vi se en positiv start på næste uge. Der skal ikke så meget til før stemningen skifter. Men lad os være tilfreds med en trods alt tilfredstillende uge.

[JKY_VH]

enig bibob og god weekend:-)

[transalp]

Lyder rigtigt bob, go weekend til dig også..:)