<![CDATA[Genmab — August 2015]]>Fandt denne artikel med Jan på en Hollandsk hjemmeside. ‘Ik wil van Genmab het volgende Regeneron maken’ - http://www.gamechangersutrecht.nl/article/ik-wil-van-kanker-een-chronische-ziekte-maken

]]>https://dev.proinvestor.com/forum/topic/451485/genmab-august-2015RSS for NodeThu, 18 Jun 2026 12:08:12 GMTSat, 01 Aug 2015 04:09:01 GMT60<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 19:38:11 GMT]]>Tak Darvin for et godt indspark: http://www.proinvestor.com/?p=debat_1&postid=73067&thread=50&start=

]]>https://dev.proinvestor.com/forum/post/10100839https://dev.proinvestor.com/forum/post/10100839Mon, 31 Aug 2015 19:38:11 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 19:01:24 GMT]]>Her er også en lille teaser, imens vi venter http://www.biopharmadive.com/news/jjgenmab-unveil-promising-data-for-a-potential-multiple-myeloma-superstar/404734/

]]>https://dev.proinvestor.com/forum/post/10100841https://dev.proinvestor.com/forum/post/10100841Mon, 31 Aug 2015 19:01:24 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 18:46:37 GMT]]>😉

]]>https://dev.proinvestor.com/forum/post/10100843https://dev.proinvestor.com/forum/post/10100843Mon, 31 Aug 2015 18:46:37 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 18:46:23 GMT]]>Skrev lige en lille teaser eller opmuntring i debatten nu hvor vi ikke kan finde ud af at sætte den rette kurs

]]>https://dev.proinvestor.com/forum/post/10100837https://dev.proinvestor.com/forum/post/10100837Mon, 31 Aug 2015 18:46:23 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 18:06:44 GMT]]>NBI -3,1%. Så vi skal meget
gerne ha' nogle gode PMI-tal fra Kina i nat.

]]>https://dev.proinvestor.com/forum/post/10100836https://dev.proinvestor.com/forum/post/10100836Mon, 31 Aug 2015 18:06:44 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 16:51:39 GMT]]>US ser noget dyster ud her til aften:-(

]]>https://dev.proinvestor.com/forum/post/10100838https://dev.proinvestor.com/forum/post/10100838Mon, 31 Aug 2015 16:51:39 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 13:35:00 GMT]]>Ja. Ibrutinib er er vist en af ret få undtagelser, hvor det gik lidt hurtigere

]]>https://dev.proinvestor.com/forum/post/10100842https://dev.proinvestor.com/forum/post/10100842Mon, 31 Aug 2015 13:35:00 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 13:14:21 GMT]]>Sådan husker jeg de få eksempler man har fuldt på nært hold

]]>https://dev.proinvestor.com/forum/post/10100832https://dev.proinvestor.com/forum/post/10100832Mon, 31 Aug 2015 13:14:21 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 13:09:57 GMT]]>Var det ikke dig der forleden skrev at FDA normalt/altid bruger alle 60 dage til at beslutte om PR?

]]>https://dev.proinvestor.com/forum/post/10100833https://dev.proinvestor.com/forum/post/10100833Mon, 31 Aug 2015 13:09:57 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 13:08:11 GMT]]>Responsrater (ORR) er et surrogat endpoint - og BTD har vel nærmest pr automatik indbygget fast track og accelerated approval.

]]>https://dev.proinvestor.com/forum/post/10100835https://dev.proinvestor.com/forum/post/10100835Mon, 31 Aug 2015 13:08:11 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 13:07:51 GMT]]>Tak gutter.:-)

]]>https://dev.proinvestor.com/forum/post/10100829https://dev.proinvestor.com/forum/post/10100829Mon, 31 Aug 2015 13:07:51 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 12:39:06 GMT]]>Ja, det er noget andet: For purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is thought to predict clinical benefit, but is not itself a measure of clinical benefit.

]]>https://dev.proinvestor.com/forum/post/10100830https://dev.proinvestor.com/forum/post/10100830Mon, 31 Aug 2015 12:39:06 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 12:31:00 GMT]]>Så det er forklaringen på den hurtige behandling: The FDA is approving Imbruvica un
der the agency's accelerated approval program

]]>https://dev.proinvestor.com/forum/post/10100828https://dev.proinvestor.com/forum/post/10100828Mon, 31 Aug 2015 12:31:00 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 12:28:19 GMT]]>http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm374761.htm

]]>https://dev.proinvestor.com/forum/post/10100827https://dev.proinvestor.com/forum/post/10100827Mon, 31 Aug 2015 12:28:19 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 12:23:44 GMT]]>Går det ligeså hurtigt for dara er der kun 2 mdr igen til godkendelse

]]>https://dev.proinvestor.com/forum/post/10100831https://dev.proinvestor.com/forum/post/10100831Mon, 31 Aug 2015 12:23:44 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 12:20:13 GMT]]>Ja, dvs 4 mdr fra ansøgning indsendt til 1. godkendelse. Men havde de PR?

]]>https://dev.proinvestor.com/forum/post/10100824https://dev.proinvestor.com/forum/post/10100824Mon, 31 Aug 2015 12:20:13 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 12:16:42 GMT]]>
Access Denied

favicon

(www.drugs.com)

]]>https://dev.proinvestor.com/forum/post/10100823https://dev.proinvestor.com/forum/post/10100823Mon, 31 Aug 2015 12:16:42 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 12:16:17 GMT]]>FDA kan uopfordret bevilge PR, men man kan også som ansøger anmode om det. Den review clock omtalt i gentogens citat er tiden til den samlede behandling af ansøgningen. Og af den er der 4 mdr tilbage hvis PR bevilges (senest kommende søndag)

]]>https://dev.proinvestor.com/forum/post/10100834https://dev.proinvestor.com/forum/post/10100834Mon, 31 Aug 2015 12:16:17 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 12:14:53 GMT]]>Kan ikke huske det. Var det ikke 4 mdr?

]]>https://dev.proinvestor.com/forum/post/10100825https://dev.proinvestor.com/forum/post/10100825Mon, 31 Aug 2015 12:14:53 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 12:10:52 GMT]]>Hvor hurtigt gik det royal?

]]>https://dev.proinvestor.com/forum/post/10100821https://dev.proinvestor.com/forum/post/10100821Mon, 31 Aug 2015 12:10:52 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 12:04:07 GMT]]>Men når først FDA melder ud kan det gå stærkt. Som med Ibrutinib.

]]>https://dev.proinvestor.com/forum/post/10100840https://dev.proinvestor.com/forum/post/10100840Mon, 31 Aug 2015 12:04:07 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 11:56:45 GMT]]>Roger, men så er Rolling jo ikke nødvendigvis meget værd.

]]>https://dev.proinvestor.com/forum/post/10100826https://dev.proinvestor.com/forum/post/10100826Mon, 31 Aug 2015 11:56:45 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 11:55:20 GMT]]>f FDA accepts a portion of an application, this does not necessarily mean that review will commence or proceed before the complete application is submitted.

]]>https://dev.proinvestor.com/forum/post/10100820https://dev.proinvestor.com/forum/post/10100820Mon, 31 Aug 2015 11:55:20 GMT<![CDATA[Reply to Genmab — August 2015 on Mon, 31 Aug 2015 11:54:43 GMT]]>The review clock will not begin until the applicant informs the Agency that a complete BLA or NDA was submitted.46 After the Agency is notified of the complete application, we will make a filing determination within the usual time.

]]>https://dev.proinvestor.com/forum/post/10100819https://dev.proinvestor.com/forum/post/10100819Mon, 31 Aug 2015 11:54:43 GMT