Genmab — Juli 2018

transalp

Go morgen :.

bibob

God morgen.

Parasitism

God morgen

Helge_LarsenPI-redaktør

Træet morgenrystes.

Legolas23

Faldet er ikke specifikt, men generel for alle aktier. Is i maven og send en tanke til Trump´.

Legolas23

Tynd volume igen idag. Nordea hælder ud og de anonyme køber op.

Helge_LarsenPI-redaktør

ENS kommer måske fra baghjul igen i dag.I går så de lige feltet an om formiddagen før de stak af på købssiden.

bibob

Kunne være samme mønster i dag.

peter12

Dejligt med en købsalgoritme

E_L

Pharmacovigilance Risk Assessment Committee (PRAC)
Draft agenda for the meeting on 09-12 July 2018 / Medicines in the post-authorisation phase – CHMP-led procedures / 5.3.5. Daratumumab

E_L

Scope: Extension of indication to include the combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

E_L

Action: For adoption of PRAC RMP AR, PRAC RMP assessment overview and advice to CHMP

E_L

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European Medicines Agency (EMA) (www.ema.europa.eu)

E_L

deafening silence…

E_L

anyway, who has enough procedural knowledge to know, if PRAC gives a positive advice to CHMP, is it possible for CHMP to approve immediately in their next meeting?

mobbyduck1

from positive CHMP, it is still gonna take 67 days to approval??

Legolas23

@Bulder ? @Sukkeralf ? @Solsen ?

gentogen

Det hedder, at "The PRAC is responsible for assessing all aspects of risk management of human medicines" , så umiddelbart ville jeg gætte på, at det lige passer med tidsplanen til næste CHMP i slutningen af juli

gentogen

og at de altså reelt afgør det.

mobbyduck1

men det tager stadig 67 dage til approval derfra ikke??