Genmab — Marts 2019

gentogen

EL: About your comment 23:10 I think you should look at page 14 where the PDUFA date for Ribociclib 28/12 is explaines as the PDUFA date that 'normally' would have been the date but actually the drug was approved July 18

gentogen

So as I see it the table is explaining the advantage of RTOR

E_L

you are definately correct. I think Bulders' question was more if there was a different PDUFA date for an RTOR. I can not find anywhere that this is the case. The press release showed no date.

E_L

PDUFA dates are deadlines for the FDA to review new drugs and for priority review the FDA has 6 months to review ; i assume that is the same here, but this is only the MAXIMUM time; the RTOR is offcourse meant to make it much faster

E_L

looking at the other examples, i think there is a good chance we could get it somewhere at/towards the end of april? but it CAN take longer

StockBull

Altid noget Alligator Bio rykker lidt idag. Mon ikke den bunder her omkring 20-21 kr

StockBull

Men godt nok mager volumen

Bulder

I think you are right E L. The PDUFA date is 6 mths from submission. But only in the case that RTOR doesn't work. If the application is changed to normal/priority review. If RTOR works it'll be conciderably shorter, but still flexible.

AaBforever

Ja der er ikke meget "svung" opad på denne nyhed.

StockBull

Hvad er konklusionen m.h.t RTOR ? godkendelse inden 4 uger ?

Helge_LarsenPI-redaktør

Just a moment...

(www.proinvestor.com)

AaBforever

Konklusionen er nok at ingen ved det...

AaBforever

Gætværk..som vi siger heroppe nordpå..:-)

StockBull

også min konklusion

StockBull

måske man skulle spørge den ny informationschef

Bulder

Ja, havde det været R. Gravesen ville hun have svaret "soon".

Sukkeralf

....and Jan "very soon" or "within weeks"

Bulder

Den nye (Peron): mañana

AaBforever

Nå..alt er ved det gamle...positiv nyhed..aktien falder...dog kun en smule..:-)

peter12

2900 x dara (nye) i UK må da kunne ses på salget ? Et slag på tasken 0.4 mia$ pr år ?