Genmab — April 2020

[E_L]

Dara SC on the CHMP agenda again, under 'opinion'; bit surprised, was there no 'clock stop' after the march 180day meeting? ; could we get this done this week now?
https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-agenda-28-30-april-2020-meeting_en.pdf

[E_L]

yea, but it says that at every step

[E_L]

what is more interesting is that it is under paragraph 4.1, which is 'opinion'

[E_L]

maybe they dealt with it yesterday and declined it, and that is why we are down today

[Sukkeralf]

NBI was down 2% yesterday

[E_L]

ps. , @Hamming , Genmab is somewhat involved in a Covid trial via BMS-986253 https://clinicaltrials.gov/ct2/show/NCT04347226

[E_L]

i was putting a smiley Sukkeralf

[E_L]

but , hey , you never know, we are always the last ones to find out

[E_L]

and an example of that is here, on ADCT-301 https://www.fiercebiotech.com/biotech/one-ipo-attempt-pulled-a-drug-partial-hold-and-a-pandemic-but-adc-tx-tries-again

[E_L]

@gentogen remember? i thought it was fully accrued and you had doubts about that- it seems you were right...

[E_L]

'has been hit with a partial clinical hold'

[E_L]

(article also says: Cami is now on track to read out next year)

[Sukkeralf]

but timelines are changeable dependent on how the FDA handles this latest partial hold.

[Sukkeralf]

Not good

[E_L]

Gilead halted,
Remdesivir news?

[E_L]

market going wild

[E_L]

$GILD: Trial meets primary endpoint, positive data emerging for Remdesivir

[E_L]

fortunately every day trader is a Covid specialist these days sigh

[kkjoel]

Deres resultat er vel i denne omgang ikke noget helt vildt - de har vist at de får samme efffekt ved at behandle 5 dage som 10 dage. På pts, der allerede var hospitalsindlagte med symptomer på lungebetændelse uden behov for respirator. Godt halvdelen af disse pts kunne hjemsendes 14 dage efter deres deltagelse i studiet blev påbegyndt.

[kkjoel]

Men der er ingen sammenligninger med hvor mange af sådanne pts der blev hjemsendt uden samme behandling (eller en placebobehandling for den sags skyld), så man ved intet om hvor effektiv behandlingen er. De havde god bivirkningsprofil, ok. Det er fint. Men vi har et resultat, der viser at en vis procentdel af patienterne får det bedre efter at have være indlagt et stykke tid. Og det vifdste vi i forvejen. Vi er slet ikke i nærheden af en vaccine.