Genmab — Februar 2019
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this dara -ninlaro trial from Suspended to Recruiting -again . still expected to be completed in april https://clinicaltrials.gov/ct2/history/NCT03012880?A=9&B=10&C=merged
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the Oncopeptides 2018 report contained a few interesting referrals to Dara.
https://www.google.nl/url?sa=t&rct=j&q=&esrc=s&source=web&cd=55&ved=2ahUKEwiWy4iU7tHgAhXhMewKHQ-2AYgQFjA2egQIJhAC&url=https%3A%2F%2Fwww.oncopeptides.se%2Fen%2Fwp-content%2Fuploads%2Fsites%2F2%2F2019%2F02%2Foncopeptides-year-end-report-2018-190222.pdf&usg=AOvVaw3Qrn-FuyWSj10A1bH4jzMf -
Vedr. nyhedsflow: Vi kan også forvente Griffin-data her i H1. Der var primary completion 25. januar, så data kan komme når som helst. M.h.t. tidsplan så ser jeg Maia RTOR marts/april. Columba(sc) april/maj. Asclepios (ofa rms) i juli og hvis TV i LMHK færdigrekrutteres i april får vi data i november og ansøgning i beg. af 2020.
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First of all, RTOR filing. What I can say is that Janssen is right now filing in different parts -- pieces, the filing to speed up the process, and we think that by next month, that most of the components will be in at the FDA, and then it depends on how quickly the FDA can make up their decision to combi the label
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So it could be very rapid. That's probably all I can say about it. And apparently, it's a pretty big file, what I understand from our colleagues at Janssen. But I cannot go into details on how this filing is different from the other Phase III trials, James.
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Winkel svarede i november på mit spm.: The GRIFFIN study is a Ph 2 study for which the data will become available in the first
half of 2019. These data can then be published in a peer reviewed scientific journal
and may well be included in the compendium guidelines. This could make the
combination of DARA with VRD reimbursible in the US market... -
I hvert fald er gns.alderen 70 år og 37% er yngre end 65, hvilket gør dem asct-egnede, hvis der ikke er andet der forhindrer det. Så Griffin vil henvende sig til en meget stor del at populationen. http://www.bloodjournal.org/content/bloodjournal/early/2018/07/03/blood-2017-05-693606.full.pdf?sso-checked=true
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