Genmab — November 2022

[Bulder]

Undskyld SB. Der er faktisk et maximum på 60 dage.

[Bulder]

Men det betyder så at epco ansøgningen er i god tid inden nytår.

[gentogen]

The timelines for NMEs and BLAs that fall under PDUFA V’s “Program”
Review Model are 10-months for standard applications and 6-months for priority reviews from the 60-day filing date (or 12 months
and 8 months respectively from the date of submission of the application).

[gentogen]

Alle detaljer findes her: https://www.fda.gov/media/78941/download

[kkjoel]

Hvordan kan det egentlig være at GEN får den store klump penge (nævnt forleden i opjusterings PM'en) ved accept af ansøgningen og ikke ved selve
godkendelsen? (eller måske de bare får en endnu større klump ved godkendelsen...?!)

[kkjoel]

(@Duoblo - Nej er på Nørrebro.. men har siden 80'erne holdt meget af "Humus med det hele".. senere kom Shawarma-kødet så bare med.)

[Legolas23]

Kender vi størrelsen af milestone for epco godkendelse?

[Bulder]

Det har også undret mig at de får Milestone ved acceptance. Men Andrew Carlsen bekræftede jo ved sidste q&a, at det gør de. Om de så får igen ved godkendelse må tiden vise. Hvad angår størrelsen, skrev de forleden i meddelelsen, at den var signifikant. Det er hvad vi ved - så vidt jeg ved.

[bibob]

GSK’s Blenrep fejlede endemål i MM. https://www.reuters.com/business/healthcare-pharmaceuticals/gsks-blood-cancer-drug-fails-main-goal-superiority-trial-2022-11-07/

[E_L]

ha, you beat my by a second

[E_L]

it looks like that one isn't going to give a lot of competition...

[bibob]

EL.

[bibob]

Yes one more out.

[E_L]

small mention of epcoritamab in the EMEA CHMP agenda for this week, under B.6.1. Start of procedure for New Applications: https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-7-10-november-2022_en.pdf

[E_L]

also talquetamab, under 8. Pre-submission issues - on the request for accelerated
assessment.

[E_L]

BioNTech Announces Third Quarter 2022 Financial Results and Corporate Update https://investors.biontech.de/news-releases/news-release-details/biontech-announces-third-quarter-2022-financial-results-and - Presentation - https://investors.biontech.de/static-files/49e8b81b-bc33-4d65-85ea-c935610dd6b2

[E_L]

Safety and preliminary efficacy data of BNT312 combination therapy in patients with advanced solid tumors are planned to be presented at the ESMO-Immuno-Oncology annual congress in December 2022. =GEN1042

[deleted-user]

Genmab sammen med Bava, har ingen omsætning i dag, så det er nok Hr. og Fru. Jensen der styrer markedet med de små handler.

[Bulder]

Esmo abstract Dec 1. At 00.05 https://www.esmo.org/meeting-calendar/esmo-immuno-oncology-congress-2022/abstract

[Bulder]

https://www.esmo.org/meeting-calendar/esmo-immuno-oncology-congress-2022/abstracts