Genmab — Maj 2018

[Solsen]

Det har du sikkert ret i Bulder. Jeg var lidt for hurtig. Spændingen og forventningen er ikke blevet mindre !

[KWC]

Ved ikke om det er relevant i forhold til Genmab.. https://www.fiercepharma.com/pharma/merck-s-keytruda-roche-s-tecentriq-may-be-hurting-some-patients-survival-fda

[KWC]

Merck's Keytruda, Roche's Tecentriq may lag chemo in some cancer patients, FDA says

[Bulder]

Vi havde det oppe d. 19/5 om fomiddagen

[Solsen]

Mon ikke man kunne søge godkendelse på 120 pts forudsat signifikans ?

[E_L]

Agree with Bulder and therefore believe the message is overall positive. Also, preparing for SC is very important.

[E_L]

It would be interesting to know now if the trial was already delayed REGARDLESS of the extra 30 patients. If not, we need to know why Janssen think 30 extra is worth delaying results by 7 months (Would a phase 3 require more patients?)

[E_L]

However, we have to realise, early public phase 2 results are mainly of interest for us; Janssen will have full insight anyway. If they can tweak this phase 2 a bit to kick start phase 3 as Bulder suggests they may even speed up the approval.

[E_L]

These guys are not stupid, I am sure there is a good reason.

[Bulder]

Solsen, teoretisk kunne man vel godt søge godkendelse med 120 pts, hvis data er tilstrækkeligt gode. Men det ville i så fald blive en betinget godkendelse (ligesom dara-pom-dex), hvor der under alle omstædigheder skal et fase 3 studie til.

[Bulder]

E L we don't know if preliminary data regarding the 96 pts will be delayed. But as Winkel said at CC, the level of details is uncertain.

[Bulder]

Nevertheless I am much more confident now than before, given the fact that Janssen is expanding the whole study. They wouldn't expand a dead cat. Smells bad. This expansion is almost as good as a read out. Surely we cannot know how good data are, but they are good enough to a continuation.

[E_L]

fully agree

[Bulder]

Omsætningen af GMXAY er usædvanligt høj, 113k

[Solsen]

Husk ARD er 1:10

[Bulder]

Jo, men der er vel heller ikke udstedt så mange som der er aktier?

[E_L]

trading slightly higher as Danish close anyways

[Solsen]

Winkel har givet udtryk for, at man har indblik i data og nu diskuterer, hvilke og hvornår data frigives. Samtidig ser vi udvidelse med 30 pts til i alt 120 pts ligeligt fordelt på to arme i forsøget. Jeg synes det lugter af pivotal trial !

[Thomas]

Er det efter reglerne hvis de har indblik i nogle fornuftige data og ikke melder noget ud til markedet?

[StockBull]

Morning