Genmab — Maj 2021

[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

[StockBull]

Tror også det er derfor Jan kommer med disse små indikationer om 2-3 dopling af kursen som support for de almindlige investors

[StockBull]

ind til vidre har han jo haft ret

[Vitus]

Det vil ikke undre, hvis du også får ret StockBull....det har du jo før haft

[Vitus]

Det minder mig lidt om en bankgaranti.....

[E_L]

Revlimid revenue Q1 $2.944bn, still amazing, but losing steam (last year Q4 was 3.280, Q1 2.915)

[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 https://www.ema.europa.eu/en/documents/other/committee-orphan-medicinal-products-comp-meetings-2019-2020-2021_en.pdf

[Sukkeralf]

Wrong link?

[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

[Sukkeralf]

https://endpts.com/pfizer-hits-the-brakes-on-their-pivotal-trial-for-a-bcma-cd3-bispecific-after-a-string-of-peripheral-neuropathy-cases/

[E_L]

correct link https://www.ema.europa.eu/en/documents/minutes/minutes-comp-meeting-16-18-march-2021_en.pdf

[E_L]

good to know that at least 1 person tries to read
it

[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.

[JørgenVarnæs]

It’s the EGFR “subset” of nscl that cannot be considered well-defined

[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

[JørgenVarnæs]

I do find the EMA argumentation a bit confusing

[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

[E_L]

and NSCLC is too large a disease to fall under orphan

[Bulder]

I don't know how important an orphan designation is? Gives some priviliges, but else?

[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. https://www.ema.europa.eu/en/human-regulatory/overview/orphan-designation-overview