Genmab — Februar 2019

[Solsen]

Jo alle de penge i fremtiden er gode nok. Men jeg påpeger blot at nuværende opgivende stemning ikke løses af nogle udviklingsaftaler. Men aftaler på lidt mere modne stoffer med højere upfront kunne give det løft i kursen alle sukker efter. Specielt håber jeg at data på CD3/CD20 kunne fremdrive en pæn aftale. Time will show.

[JørgenVarnæs]

Det er ved at være 3 uger siden vi fik RTOR meddelelsen - det kunne være forrygende med en af de gode gamle fredagsnyheder efter luk!!!

[Helge_LarsenPI-redaktør]

Åh nej..Den slags gjorte det så svært for mig at komme på arbejde lørdag morgen.

[JørgenVarnæs]

Du er sikker på, at det ikke var den resulterende rødvin, der skabte problemerne?

[transalp]

:))

[JKY_VH]

Det var den gang, hvor garageporten skulle beklædes med bladguld og der skulle graves ud til en stor vinkælder

[E_L]

where do you think we are on that RTOR timeline? i saw earlier in this onclive article "Janssen and Genmab have completed the first part of a supplemental biologics license application for daratumumab …." https://www.onclive.com/web-exclusives/fda-approves-splitdosing-regimen-of-daratumumab-for-multiple-myeloma?p=2

[peter12]

EL later it says : The agency is reviewing the sBLA under the Real-Time Oncology Review pilot program

[peter12]

BTW GMXAY is higher tonight so may some surprises around the corner

[nohope]

GMXAY is not a good indicator to GEN.

[E_L]

well yeah, that is part of the sentence, the question is, where are we in the RTOR, what part of the application have they completed , are we in week 6/9 or week 16?

[Solsen]

14-16 I belive - from top line data announcement.

[Solsen]

All we need is announcement on last dataset submitted. And after that we need a week or so.

[Bulder]

According to the timeline first submission takes place 6-9 weeks after top line. That was 3 weeks ago. Lets say week 12 now then. Which means another 4 weeks to last submission. And then another 4 weeks until decision. This is maximum. Could be shorter.

[Bulder]

Could also be within 4 weeks if data are ready.

[Bulder]

I guess that if they announce last submission, they'll also announce PDUFA date.

[Solsen]

You could be right. But the timeline are not that narrow or firm according to previously approvals under RTOR.

[JørgenVarnæs]

Der er lidt baggrund omkring de forskellige godkendelsesprocessen her - https://www.focr.org/sites/default/files/pdf/ROTR White Paper 1.pdf

[JørgenVarnæs]

Se specielt side 8 med diagrammer for kisqali og Keytruda rtor processer

[Bulder]

Ja i Kisqalis tilfælde gik der 3 uger fra full dossier til godkendelse. I Keytrudas tilfælde 5 mdr. Og vi ved jo ikke hvor lang tid Janssen er om at færdiggøre full dossier.