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5/5 08:14 af E L |
i also recently saw some BCMA ADC's being stopped, one of them might have been Amgen also, can't remember
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5/5 08:13 af E L |
AMG 420 was halted a while back and is followed by AMG 701. but that wasn't going flawless either: AMG 701 Enrollment in the Phase 1 study has been paused while we discuss protocol modifications to optimize safety monitoring and mitigation with the FDA. Currently enrolled patients who are demonstrating benefit may continue to receive investigational product and the Company expects to resume patient enrollment in H1 2021
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5/5 06:49 af Helge Larsen/PI-redaktør |
Yellen hverken forudså eller anbefalede renteforhøjelser - GENT (link)
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5/5 06:48 af Helge Larsen/PI-redaktør |
Onsdagens aviser med Pandora, Jyske Bank og Huscompaniet (link)
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5/5 06:41 af Helge Larsen/PI-redaktør |
Go morgen. :-)
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4/5 22:20 af Bulder |
Ikke så vidt jeg kunne se
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4/5 22:19 af Bulder |
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4/5 21:57 af Sukkeralf |
Anybody remember if Janssen saw peripheral polyneuropathy with thair BCMA/CD3 candidate
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4/5 21:55 af Sukkeralf |
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4/5 21:55 af Sukkeralf |
Amgen saw two cases of peripheral polyneuropathy in a 42-subject study of its rival bispecific AMG 420. The BCMA bispecific is no longer featured in Amgen’s pipeline.
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4/5 17:02 af E L |
i agree it is mainly about market exclusivity , but i do think that can be important with the rapid development of copy cats and generics. But i agree that it would only be for a small part of the market they may eventually target, as we know that they wouldn't get orphan for the whole NSCLC indication (if they decide to go for that broader label)
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4/5 16:48 af Sukkeralf |
Here were it is the first indication they go after its almost of no importance
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4/5 16:47 af Sukkeralf |
Agree
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4/5 16:30 af Bulder |
As I see it "market exclusivity" is most important. A good thing to have of course, but not nescessary.
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4/5 16:27 af Bulder |
The prevalence must not be more than 5 in 10.000, so they (Janssen) tried in vain to narrow it in.
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4/5 16:25 af Bulder |
Sponsors who obtain orphan designation benefit from protocol assistance, a type of scientific advice specific for designated orphan medicines, and market exclusivity once the medicine is on the market. Fee reductions are also available depending on the status of the sponsor and the type of service required. (link)
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4/5 16:23 af Bulder |
I don't know how important an orphan designation is? Gives some priviliges, but else?
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4/5 15:35 af E L |
and NSCLC is too large a disease to fall under orphan
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4/5 15:34 af E L |
my interpretation is that JNJ tried to narrow the definition of the targeted disease to a small subsector of NSCLC in an attempt to get orphan status; in a nutshell: EMA rejects that subsector definition
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4/5 15:30 af JørgenVarnæs |
I do find the EMA argumentation a bit confusing
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4/5 15:26 af E L |
yes, i would say it is a fair argument by EMA, we'll see if JNJ will appeal, but it is good that it is clarified, ie. the reason is not effectiveness or something like that, on the contrary, EMA seemed rather positive about the drug
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4/5 15:17 af JørgenVarnæs |
It’s the EGFR “subset” of nscl that cannot be considered well-defined
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4/5 15:16 af JørgenVarnæs |
Thanks EL - seems this is the pertinent part: The variable nature of the EGFR mutations in the proposed condition and the overlap with other oncological conditions with EGFR alterations could not be clarified by the sponsor thus raising doubts about the distinctiveness of the proposed condition. There are no international classifications that define the proposed condition as unique.
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4/5 15:12 af E L |
good to know that at least 1 person tries to read
it ;-)
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4/5 15:11 af E L |
correct link (link)
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4/5 14:52 af Sukkeralf |
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4/5 14:51 af Sukkeralf |
Pfizer hits the brakes on their pivotal trial for a BCMA/CD3 bispecific on safety concerns, reports an FDA roadblock is holding up Duchenne MD PhIII
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4/5 14:34 af Sukkeralf |
Wrong link?
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4/5 14:09 af E L |
Committee for Orphan Medicinal Products (COMP)
Minutes for the meeting on 16-18 March 2021 -interesting to read the reasons for declining orphan status for amivantamab last march (link)
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4/5 13:25 af E L |
Revlimid revenue Q1 $2.944bn, still amazing, but losing steam (last year Q4 was 3.280, Q1 2.915)
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4/5 12:08 af Vitus |
Det minder mig lidt om en bankgaranti.....
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4/5 12:05 af Vitus |
Det vil ikke undre, hvis du også får ret StockBull....det har du jo før haft :-)
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4/5 11:47 af StockBull |
ind til vidre har han jo haft ret
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4/5 11:47 af StockBull |
Tror også det er derfor Jan kommer med disse små indikationer om 2-3 dopling af kursen som support for de almindlige investors
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4/5 11:45 af StockBull |
Ja det hele er lidt presset. M.t.h Genmab p.t og kan selvfølgelig også være andre aktier så er det altid sådan at der er masser af insiders som ved mere end os almindelige. Der er store investors som ved mere og som har networks, de kan købe info og de kan holde kursen som det passer dem og derved have en fordel overfor os almindelige. Tror bare man skal have is i maven det næste års tid
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4/5 11:36 af Bulder |
Der er ikke meget, der ikke er rødt i dag. Ofte set mønster på disse dage: Liften op den første time, og så ellers ned ad den røde piste.
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4/5 11:26 af StockBull |
fedt=fede
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4/5 11:25 af StockBull |
Det er jo det der er det fedt ved aktie picking - nemlig at kunne spotte de aktier som har fået for mange bank så som Genmab og Gravity - dermed ikke sagt at de begge kan falde 10% mere inden bøtten vender mod nye ATH
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4/5 11:21 af StockBull |
reward - risk ratio er i den høje ende hvis man kan vente 1 års tid. Er da enig der er andre som også kan rykke meget så som Gravity som har fået en del bank på det sidste . GRVY - burde kunne rykke 100% på 1-2 år
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4/5 11:14 af StockBull |
Jovist Vitus men potentialet er mega i Genmab hvis pipelinen basker og en CEO der snakker om 3 dopling. Det er er ikke mange andre firmaer som kan stikke. Hvis du har andre interessandet aktier i samme klasse lytter jeg gerne
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4/5 11:05 af Vitus |
Genmab har allerede Godfather på.....dog den forkerte vej..
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4/5 11:02 af Vitus |
StockBull...med dine forbehold så kan det bestemt ikke gå galt....men det kan det vel ikke med ret mange aktier...
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4/5 10:55 af Peter Panik |
Enig...ser jeg da frem til..men der vil nok komme nogle gevaldige bump undervejs.
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4/5 10:50 af StockBull |
Ja det må man sige. Hvis ellers kommende pipeline data er gode burde vi ligge mindst over kurs 3500 om et års tid hvis ellers det globale marked generelt er positivt.
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4/5 10:32 af Peter Panik |
Luften skal da vist tages helt ud af Genmab inden regnskab.
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4/5 07:07 af Helge Larsen/PI-redaktør |
Tirsdagens aviser med negative renter, grøn aftale og skattesag (link)
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4/5 07:06 af Helge Larsen/PI-redaktør |
Asien: Store regionale forskelle på lukkedag i Tokyo og Shanghai - NY (link)
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4/5 07:03 af Helge Larsen/PI-redaktør |
God morgen. :-)
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4/5 06:32 af transalp |
Go morgen.? :)
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3/5 18:55 af Vitus |
For mig er der stor forskel på Vitus og virus....hvis du ikke ved det :-(
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