Genmab — November 2018

[Plimsoller]

God morgen

[bibob]

God morgen.

[transalp]

Go morgen

[bibob]

Bliver der ladet op til R&D og MAIA Late breaker siden der er så stille, ?? . Eller er alle gået i winter mode.

[AaBforever]

De er måske ude for at hente pakker i diverse overfyldte pakkeshops..:-)

[JKY_VH]

Vi kan da håbe, at det er stilhed før stormen af outstanding nyheder bibob:-)

[E_L]

i am searching hard but this is the only 'news' i could find on MAIA https://twitter.com/szusmani/status/1068230695430975488

[E_L]

Dr. Ola Landgren Of MSKCC Selects His Top 5 ASH 2018 Myeloma Abstracts https://www.myelomacrowd.org/dr-ola-landgren-of-mskcc-selects-his-top-5-ash-2018-myeloma-abstracts/

[E_L]

Mohty https://twitter.com/Mohty_EBMT/status/1068264359397273600

[E_L]

https://twitter.com/Mohty_EBMT/status/1068288762680008704

[Plimsoller]

Do we know anything about RTOR?

[E_L]

no, I have asked FDA 2 times via twitter if there is a list of drugs on the RTOR program, but they did not even reply. I can't find anything on the FDA website

[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"