Apropos FTF: Har de noensinne tidligere vært oppe i så mye som 5,2 mill aksjer…?
Fristen i USA er 90 dager… Tipper de søkte ODD rundt oppdateringen 2. april. Mao kan det komme en oppdatering anytime nå.
1 Like
tror utgangspunktet er 5,6mill
1 Like
Er visst 5,2 mill som er utgpunktet ser det ut for…
FTFs beholdning i Nano ved ærskiftet: Nordic Nanovector 5 233 865 7,91 %
(tatt fra årsrapport https://www.folketrygdfondet.no/getfile.php/133373-1582616749/Dokumenter/Årsrapportering/2019/Aksjer%20per%2031.12.2019.pdf )
Da har de nok verken kjøpt eller solgt noe ser det ut for…
1 Like
Nano guider likefullt late q2/early q3, så tror det kan være lurt å forholde seg til det utfallsrommet…
1 Like
Og hvor man skal ta dato for henvendelse til FDA / møte fra er vel bare spekulasjoner.
Tipper juli/ august er mer fornuftig å forholde seg til.
Interim også.
Kommer det før er det jo artig.
Det som bør komme snart er ODD designasjon.
1 Like
Hvor artig er avhengig hva som kommer 
Møtet har vel allrede vært? Det er vel utfallet av dette vi venter på nå? Tror ikke dette har noe med 75-dagersfristen å gjøre.
Fra linken til @anon35004485:
Documentation of meeting outcomes, agreements, disagreements, and action items is critical to ensuring that this information is preserved for meeting attendees and future reference. FDA minutes are the official record of the meeting. The official, finalized minutes will be issued to all FDA attendees (with copies to appropriate files) and to the sponsor or applicant within 30 days of the meeting.
De har økt hele forrige uke til og med idag…men usikker hvor positivt det er!
Alle aksjer ble vel levert tilbake ifbm GF forrige onsdag – Blir spennende å se utviklingen i beholdningen deres framover… Kan vel nesten gå ut fra at alt som forsvinner fra den kontoen er utlån til short…
(Husk at aksjonærlistene har 3 børsdagers forsinkelse)
Noen med abb her? Moro å se hva DM skriver om MZL-OD
7 Likes
Jada, skjønner det, men liker fortsatt å se at FTF sine aksjer kom tilbake og det ellers skjer lite negativt på topp50.
så får vi se når aksjene fyker ut igjen da.
Nordic Nanovector has announced that Betalutin (177Lu lilotomab satetraxetan) has received a positive opinion from the European Medicines Agency (EMA) on the application for orphan drug designation for the treatment of marginal zone lymphoma (MZL).
The positive opinion is expected to be adopted by the European Commission shortly states the company.
“We are very pleased to receive a positive opinion on Orphan Drug Designation in the European Union for Betalutin in MZL. There is a clear need for new therapeutic options for MZL patients who no longer respond to anti-CD20 immunotherapy (rituximab), the current backbone of treatment in first and second-line patients. We look forward to receiving the final decision by the European Commission in the coming weeks,” says Lars Nieba, Interim Chief Executive Officer, Nordic Nanovector.
LYMRIT 37-01 Phase 1/2a trial
In the LYMRIT 37-01 Phase 1/2a trial, Betalutin showed a highly encouraging 78% overall response rate (ORR) and 44% complete response (CR) in the MZL patient group (n=9) – the highest response rates of any patient sub-population in this study. This followed a once-only administration of Betalutin in this heavily pre-treated group of patients with advanced disease.
MZL is a form of indolent (slow-growing) B-cell non-Hodgkin’s lymphoma (NHL) that accounts for approximately eight percent of all NHL cases. EMA orphan designation is designed to encourage the development of new treatments for life-threatening or chronically debilitating conditions that are rare (affecting not more than five in 10,000 people in the European Union). Medicines that meet the EMA’s orphan designation criteria qualify for several incentives to help support advancement.
Betalutin received Orphan Drug Designation for the treatment of follicular lymphoma in the US and Europe in 2014.
16 Likes
TGTX filer Umbralisib i FL og MZL
1 Like
Litt MZL benchmark
The MZL cohort was designed to evaluate the safety and efficacy of single agent umbralisib, in patients with MZL who have received at least one prior anti-CD20 regimen. In February of 2019, the Company announced that the primary endpoint of overall response rate (ORR) as determined by Independent Review Committee (IRC) was met for all treated MZL patients (n=69). The results met the Company’s target guidance of 40-50% ORR. Interim safety and efficacy data from the MZL cohort were presented in oral presentations in 2019 at the American Association for Cancer Research (AACR) annual meeting, the American Society of Clinical Oncology (ASCO) annual meeting and the International Conference on Malignant Lymphoma (ICML).
Og FL benchmark
The FL cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with FL who have received at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent. In October of 2019, the Company announced that the primary endpoint of ORR as determined by IRC was met for all treated FL patients (n=118). The results met the Company’s prespecified response target of 40-50% ORR.
1 Like
TG har vel holdt kortene svært tett til brystet her. Hva tror folk om denne behandlingen? Vi vet vel knapt noe mer enn at ORR (overall) er 40-50%.
