Genmab — December 2018

[Bulder]

Nu nævnte Winkel april måned et par gange. Hvis godkendelsen kommer i april, så er det helt sikkert RTOR. Ikke engang PR ville kunne nås til april.

[Legolas23]

Men så må godkendelsen ligge lige om hjørnet, hvis der er søgt RTOR. Måske er det det den stiger på.

[Solsen]

Jeg mener, at med RTOR kan det gå noget hurtigere.

[Solsen]

Men gætværk alt sammen

[Bulder]

En anden vigtig ting i interviewet var oplysningen om den strengere måling af MRD-neg, som udelukkede VGPR-patienterne og kun medtog CR-patienterne. Kan forklare de "skuffende" 24%.

[peter12]

Det har @solsen nævnt før. Han siger endda confirmed CR

[peter12]

Altså JdW

[E_L]

it is also comforting they are conducting their own interviews with doctors, not only to estimate future sales, but they will also hopefully hear any concerns or bottlenecks.

[E_L]

13.500 patients in clinical trials, from 52.000 patients treated, imagine where we would be if those 26% of patients would also be generating revenue at the moment...

[E_L]

"they must know something"

[Joakim_Von_And]

could it be milestone tomorow???

[E_L]

that would be above my expectations; so I doubt it, but it would be super positive news, it would certainly knock my socks off

[Bulder]

Ifølge FDA's egen tidsplan for RTOR går der mere end 20 uger fra headline data til godkendelse. Derved er april ikke helt ved siden af. At det i et par tilfælde er gået hurtigere, betyder jo ikke, at det vil gå sådan hver gang. https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm612927.htm

[Solsen]

SGEN annoncerede topline data 1/10 og fik godkendelse 16/11 med RTOR - så det kan gå hurtigt. Vi håber det bedste. JW skulle have udtalt at MAIA opfylder alle kravene til RTOR....

[E_L]

in addition to that; it is a pilot program; i believe they will try this out with the Big Pharma, that have a lot of staff and experience with sBLA etc; so JNJ will be one of only a few that have a chance in my opinion, and Dara is their fastest growing drug, AND FDA has already goodplenty of experience with & and knowledge off Dara

[Solsen]

JW said today that two drugs was approved under RTOR up to now.

[Solsen]

Just heard the Børsen interview again. And no doubt that they are under RTOR review now. But there is a risk that they can be put to Priority review by FDA.

[Solsen]

Dara have 3% front line now and it could reach 10% by year end. Now we can begin calculate

[Solsen]

And my calculator says byond 200 dkk pr share - when dara reach +10bn uds

[Solsen]

If we listen carefully to JWs interview it seems that MRD measured on confirmed CRs could be the way to approval under RTOR....