Genmab

	1/5 15:52 af troldmanden	Det er alle jo.
	1/5 15:52 af troldmanden	Who Are Unable to Receive Intravenous
	1/5 15:41 af Helge Larsen/PI-redaktør	Beklager nedetiden.
	1/5 15:38 af Solsen	Se EL 10.44 - det er vel ikke for sjov man få en sådan tilladelse. Eller er det mig der er gal på den ?
	1/5 12:31 af troldmanden	Enig med sukkerr. Det kommer ikke til at ske før der er en reel US godkendelse
	1/5 12:12 af Sukkeralf	Lægemiddelvirksomhederne må ikke opfordrer til OFF label brug, så det vil ikke ske her
	1/5 12:04 af Bulder	Jo,men de må vel ikke sende det ud på markedet, før det er godkendt. Med mindre det foregår i studie-regi.
	1/5 11:55 af Solsen	JNJ købte i Q419 et stort parti af det middel som dara skal opblandes i. Så de er vel parate.
	1/5 11:43 af Bulder	Off label brug forudsætter jo, at det er tilgængeligt.
	1/5 11:39 af Solsen	Markedet burde have kendskab til det i går i børsens åbningstid. Men et popup ville være dejligt at sælge på :-)
	1/5 11:33 af The Joker	Tror i godkendelsen af den subkutane version sender Halozymes (leverandøren af teknologien) nord på i dag? Eller bliver effekten ligeså beskeden som for Genmab?
	1/5 11:17 af bikube	Kunne være et godt spørgsmål til Jan ved et evt. komende Q&A, hvor meget det bliver brugt.
	1/5 10:48 af bibob	Thx E L. - That could spare some time for the Doctors. And time is ( big ) money. ;-)
	1/5 10:45 af E L	if you have a doctor that is a bit creative, i would imagine he could get his patients on, specially in covid time. But i am not sure if it is used
	1/5 10:44 af E L	not sure in europe, but in US there is Pre-Approval Access via (link)
	1/5 10:41 af bibob	C ould Dara sc possibly be used off label allready now. ???
	1/5 10:02 af lahn1	Exciting time ahead, but wouldn't mind a double bottom ;-)
	1/5 09:51 af E L	;-) yes, could be a great summer, for Genmab. (if markets don't crash again for a double bottom or something...) Jan will probably be in a good mood next week
	1/5 09:40 af Bulder	Så får vi ofa-godkendelse, TV-data og partneraftale lige oven i hinanden
	1/5 09:38 af Sukkeralf	:-)
	1/5 09:38 af Bulder	:-) :-)
	1/5 09:37 af Bulder	very very nice
	1/5 09:37 af Sukkeralf	?????? Was a smiley
	1/5 09:37 af Sukkeralf	Nice work E L ????

	1/5 09:17 af E L	In February, a variation to the marketing authorization application was submitted to the European Medicines Agency to expand the indication for Kyprolis in relapsed multiple myeloma based on data from the Phase 3 CANDOR study.
	1/5 09:17 af E L	The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020 for the supplemental New Drug Application (sNDA) to expand the Prescribing Information to include KYPROLIS in combination with dexamethasone and DARZALEX® (daratumumab) for patients with relapsed or refractory multiple myeloma based on data from the Phase 3 CANDOR study.
	1/5 09:17 af E L	from Amgen on KYPROLIS:
	1/5 09:07 af E L	So that’s something that’s ongoing. We’re working hard at. If they may very well come this quarter, okay, and we’re working toward trying to make that happen. We just put out that it may slip a little bit into the third quarter, just in case it does but we’re working hard to get this done in the soonest time frame possible. So I wouldn’t read too much into it. And you will hear about it soon.
	1/5 09:07 af E L	A: The most important thing with our data with TV is that this is potentially registerable. And we need to follow the data and follow the duration of the data and work with a third-party that puts these type of blinded data together and before we can present this and reveal the data.
	1/5 09:06 af E L	Q: it seems like the tisotumab vedotin readout maybe got pushed back a little bit, given this trial was fully enrolled.
	1/5 09:05 af E L	We’re conducting a pivotal Phase 2 single-arm simulation trial in women with recurrent or metastatic cervical cancer where there is no standard of care and outcomes are poor. We expect to report top line results late this quarter or into the third quarter.
	1/5 09:04 af E L	Turning now out or pipeline on the horizon with a clinical trial readout is Tisotumab Vedotin or TV which we are developing in collaboration with Genmab.
	1/5 09:04 af E L	same from Seattle Genetics' Q1 2020 Results - Earnings Call Transcript (link)
	1/5 09:01 af E L	SGEN - Tisotumab Vedotin innovaTV 204 Pivotal Trial Topline Results: Seattle Genetics and Genmab expect to report topline data late in the second or into the third quarter of 2020 for the innovaTV 204 pivotal trial of tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment.
	1/5 08:51 af E L	she refers to the fact that SC is a fixed dose, where IV is a dose that varies per patient, based on body weigth
	1/5 08:48 af GeorgeBest	Thanks E L
	1/5 08:46 af E L	Mateos. “The daratumumab subcutaneous formulation has the potential to transform the treatment experience for patients and physicians as it reduces time in the chair from hours to minutes, and, because it is administered as a fixed dose from the first treatment, it reduces preparation time and chances of error by eliminating the need for dose calculations.” (link)
	1/5 08:38 af Plimsoller	Den havde jeg overset. Tak GB og Pensionisten.
	1/5 08:36 af GeorgeBest	Iflg Bulder kommer godkendelse i løbet af 67 dage (se i går kl. 20:40)
	1/5 08:30 af Plimsoller	Hvornår var godkendelsen ventet?
	1/5 08:19 af GeorgeBest	- Så jeg tror, investorerne vil godt imod den tidligere end ventede potentielle godkendelse med en lille outperformance i forhold til det resterende marked, lyder det fra Søren Løntoft Hansen (link)
	1/5 07:13 af transalp	Go morgen.. :)
	1/5 06:56 af bibob	God morgen. :-)
	1/5 06:19 af Helge Larsen/PI-redaktør	God morgen. :-)
	30/4 22:21 af Mcjean	Mon det er i morgen at kurserne skal sydpå til en ny langvarig bundvending nøjagtig som godkendelsen tikker ind, timingen har aldrig været specielt heldig for Genmab, nå men falder nok kun 3% i morgen.
	30/4 21:43 af Bella1	Måske skal du fryse resten af pighvarren ned... :-)
	30/4 21:10 af Solsen	Godt vi har aktierne. Alt det bagefis er ikke til at holde ud ....
	30/4 21:03 af Solsen	Very good it includes all indications.
	30/4 21:01 af E L	Glad to see that confirmed
	30/4 21:01 af Solsen	Jeg købte lidt HALO i forventning til hurtig gevinst :-(