Genmab — Juli 2018

[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??

[StockBull]

Ser ud til shorterne er begyndt at reducere lidt: April snit 4.25% shortet. Maj 4.14%, Juni 3.84%

[Sukkeralf]

Mobby - jo ca 2 måneder

[Bulder]

Mest sandsynligt at hvis PRAC ingen indvendinger har, så kommer det på CHMPs næste møde, og i tilfælde af anbefaling, EU-godkendelse 60 dage senere.

[mobbyduck1]

så vi snakker sept/Okt i bedste fald?