Genmab — Marts 2019

Bulder

So it took 7 weeks from initiation till full dosier. This is precisely according to the plan. From week 9 - 16. But the plan also says that now starts the PDUFA clock. If there is such a clock, I would have expected a PDUFA-date to be published as well.
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm612927.htm

E_L

i think the PDUFA date is still +6 months looking at the examples on page 13? https://www.focr.org/sites/default/files/Friends Annual Meeting Panel 3 Slides.pdf

Bulder

Well as I see it the PDUFA-date is a deadline not a period. Why have clock if not a deadline?

E_L

6 months from application submission today would be 12 september, so the clock is ticking until ultimately 12 sept

E_L

but hopefully much shorter offcourse

E_L

but that is just how i interpret it, maybe i am wrong

bibob

God morgen. :-). Ny FDA chef. https://medwatch.dk/Mennesker/article11248423.ece

transalp

Go morgen..

bibob

Lige en opfølgning på NICE fra i går. https://m.firstwordpharma.com/uk-myeloma-patients-offered-new-game-changing-option-second-line-treatment-through-cancer-drugs-fund

polle1

God morgen og god dag

Helge_LarsenPI-redaktør

Just a moment...

(www.proinvestor.com)

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.