Genmab — April 2017

[E_L]

Can anyone explain how disruptive a suspension normally is? I assume they had to stop giving the drugs to all patients, thereby losing all previous d
ata? They have to start all over again?

[E_L]

By the way, i checked with Janssen on twitter to be sure, as there was no other source: "@JanssenGlobal It appears from http://clinicaltrials.gov study NCT02715011 is not 'suspended' anymore, could you confirm that? JNJ-63709178 " Answer: "Thank you for your ques
tion. Yes, the status has changed."

[gentogen]

Ikke den vilde nyhed, men der er forresten også kommet et hospital mere med på den anden duobody i Korea

[JKY_VH]

Thank you E L

[gentogen]

When a proposed study is placed on clinical hold, subjects may not be given the investigational drug. When an ongoing study is placed on clinical hold, no new subjects may be recruited to the study and given the investigational drug; patients already in the study are expected to be taken off therapy involving the investigational drug unless treatment continuation is specifically permitted by FDA in the interest of patient safety.

[gentogen]

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm362971.htm

[Bulder]

Før clinical hold var Primary completion date 2017-11. Nu er der sat dato på: November 1, 2017. Så studiet ser ikke ud til at være blevet forsinket.

[bibob]

Som gentogen sagde : De må have brugt pausen endda særdeles godt. Bliver spændende at høre fortsættelsen.

[JKY_VH]

Nu har selv "skarpe Langer" indset det, "Genmab har fået for mange tæsk efter en nyhed uden nævneværdig betydning i det store billede" http://www.business.dk/investor/vigtige-aktieindikatorer-viser-ny-robusthed-er-det-oplaegget-til-endnu-et?referrer=RSS

[Darvin]

Mit eget regneark siger min.! 192 mio $ i US salg og mht resten så er jeg i tvivl da jeg ikke har lagt det ind på månedsniveau. Forventer 450-500 på årsbasis her, så tror 70-80 i q1 er realistisk. For US har mit regneark stemt +/- 1 pr md hidtil

[E_L]

Dara is now approved in india and will be available commercially next week. https://twitter.com/SanjivSnavangul/status/850724006080786432

[E_L]

I dont know about affordability, maybe dara is priced lower. Also, insurance coverage in India is very low. But there are a lot of people in India...

[Bulder]

Det fine denne gang er, at vi får SH-tal dagen efter JnJ's. Og da JnJ oplyser us-tal, vil vi kunne få et vink om nøjagtigheden af SH's tal. De tre månedstal skal jo helst ikke afvige meget mere end 5 % fra JnJ's Q-tal. De 5 % er den del, der ligger uden for de institutionelle kanaler.

[Bulder]

E L ved du om det er mono i 4. linje, eller om det er kombierne i 2. linje?

[JonSnow]

Hvor god en nyhed er godkendelsen i Indien, hvis det er sandt?

[Bulder]

Kan fås i Mumbai for 1 Rs/unit. Ved nogen hvor meget det er? https://dir.indiamart.com/impcat/darzalex.html?price

[E_L]

didnt say what line tumelt, see if i can find that

[Budweis]

From Blood Journals:Daratumumab (anti-CD38) induces loss of CD38 on red blood cells bit.ly/2ouEhVB

[Budweis]

(www.bloodjournal.org)

[NextLifeDK]

@Bulder; 1Rs = 10 øre. Så kr.3600 pr pakning (dosis?)