Ultimovacs (ULTI) Fundamentale forhold

[h3nk1]

Bodytekst

[polygon]

Foreløpig er dette skuffende lite mer enn hva som står i abstractet. Og det var heller ikke noen nyere cutoff, slik jeg riktignok forventet. Holom fikk p-verdien han etterlyste - 0.0985 (det var jo gitt at den lå veldig nærme i underkant av 0.1). Og så var det selve plottene. Sånn umiddelbart er det jo ikke noe positivt for å kunne si noe om effekt når et KM-plot krysser slik som i OS-plottet. Men det skjer altså på et tidspunkt etter median oppfølgingstid, slik at mange er sensurerte før dette tidspunktet. Med lengre oppfølging og mer modne data vil dette kunne endre seg. Det er altså tallene som er den viktige konklusjonen, og en HR=0.73 med en p-verdi på under 0.1 forteller at den humpen opp i kontrollarmen og den humpen ned i eksperimentell arm med 90% sannsynlighet er tilfeldig.

Men jeg hadde virkelig forventet mer opplysninger om responsdata - her trodde jeg vi skulle få både evt. CR, spiderplot etc.

[Fartin]

Du hadde nok fått cr om det var noen.

[Syvcys]

Iogmed at det kun er 1 pasient som vil bli et nytt punkt på kurven, nr at risk er 1 i UV1 armen, er det vel begrenset hvor annerledes kurva vil bli.
Dumt spørsmål kanskje, rekalkuleres KM plottet for hvert punkt som legges til, eller bare forlenges kurven punkt for punkt, dvs bare en forlengelse/ punkt til på KM plottet til UV1 gruppen?

[anon50125742]

Anne bekrefter på Twitter (som svar til LOLcat) at de sender pressemelding kl 07:00 mandag.

[docmartin]

Tenkte det selv, men fikk oppklart det i småprat

@Martins

@docmartin

Stemmer det at number at risk er 1 i Uv1-gruppa og 0 i kontrollarmen ved 30 mnd? I så fall er det vel straks komplette data og da kommer det ikke til å skje noen særlige endringer hverken den ene eller andre veien.

La oss si du får en medisin for 4 uker siden, H3nk1 får samme medisin for 2 uker siden og jeg får min i dag.

Da har man 3 at risk ved 0 tid, 2 at risk som har gått på medisinen i 2 uker og 1 at risk som har gått på medisinen i 4 uker. 0 at risk som har gått på medisinen i 5 uker. Selv om alle lever.

Nå husker jeg ikke helt, men er vel strekene på tvers som viser hvor langt hver pasient er i studieløpet per nå.

Så grafen for det jeg viser over ville vært:

Når grafene faller har noen dødd/fått progressjon, avhengig av om det er PFS eller OS man ser på.

[Martins]

Velkommen til en verden, hvor hele verden vet om UV1 på mandag. Det er verdien av ESMO

[anon50125742]

Ultimovacs har oppdatert selskapspresentasjonen med NIPU-resultatene, og jeg la også merke til at de har oppdatert “excel-arket” med de ulike kombinasjonsmulighetene sammen med CPIs, som de har vist frem i flere år.

Nå er det imidlertid inkludert en egen kolonne med “(Neo-)adjuvant”, og markert med grønt de ulike CPIene som er godkjent i disse settingene.

Ikke sikkert dette er nytt fra denne helgen, men jeg har ikke lagt merke til det før, og har ikke sett noen her som har kommentert det. Legger også ved innlegget fra @h3nk1 fra en tid tilbake, angående en mulig ny studie hvor det er snakk om bruk av UV1 i neoadjuvant setting.

Det skjer ting i og rundt Ultimovacs, og det er bare å glede seg til fortsettelsen.

Ultimovacs småprat

For dere som har lurt på hva skriveriene på insidertråden har dreid seg om, så er det altså dette: Forrige fredag dukket plutselig dette opp på Dagens Medisin. En samling foredrag fra et seminar om lungekreft. Siste foil i innlegget til en kliniker sentral i NIPU er denne: [image] UV1 skal altså inn i tidligfase. Det er et stort og viktig skritt for vaksinens rasjonale. Ref. blant annet det Gaudernack uttalte i et nylig intervju: I expect that UV1 will be used in earlier phases of tumou…

[Laaarsas]

Ajdå. Innebär ytterligare osäkerhet. Finns väl inga kliniska data för adjuvant/neoadjuvant behandling med UV1? Jag hoppas på 1L, inget annat.

[skipper]

Nå må du gi deg Lars!

[Laaarsas]

Åtminstone för de indikationer man nu kör som 1L/2L är det väl självklart att vi hoppas att man fortsätter på detta spår? Att byta riktning innebär såklart en ökad risk. Tex i mesoteliom nu med ganska lovande data. Och så talar det även för goda chanser för bra utfall i melanom. Varför det så konstigt?

[sjog]

@Laaarsas

Ajdå. Innebär ytterligare osäkerhet

Det er vel din gjennomførte “förmåga” å formulere innleggene med negativ undertone det reageres på Lars. Men nå er dette fundamental-tråden så jeg håper vi unngår diskusjon om motiver her.

[h3nk1]

@Laaarsas

Ajdå. Innebär ytterligare osäkerhet

Det virker i blant som du ikke har satt deg inn i caset. At all. At UV1 til slutt skal inn i tidligfase / profylakse er selve kongstanken bak vaksinen. POC og kombinasjon med CPI er steg én.

@h3nk1

UV1 skal altså inn i tidligfase. Det er et stort og viktig skritt for vaksinens rasjonale. Ref. blant annet det Gaudernack uttalte i et nylig intervju:

Den innovativa kraften bakom Ultimovacs cancervaccin

BioStock intervjuar professor Gustav Gaudernack, CSO vid Ultimovacs och en pionjär inom området cancerimmunterapi

I expect that UV1 will be used in earlier phases of tumour development such as the neo-adjuvant setting. I also believe that we will later move into the prophylactic setting, starting with patients having a high risk of developing cancer, either by exposure to carcinogens such as asbestos or by genetic disposition, such as variants/mutations in the h-TERT gene or other inherited cancer disposing genes.*

TET-plattformen, TENDU og PILOT (pluss andre initiativ som ikke er offentliggjort enda) er slik selskapet skal ta UV1 denne retningen. Det er ikke noe «ajdå mkt dåligt». Det er kommunisert og en sentral del av selskapets strategi.

Dette blir gjenstand for en egen «Investor / Research Day» i Q4.

At det var nettopp akademikerne involvert i NIPU som tok initiativ til PILOT sier jo litt om hva klinikerne tenker og mener (Helland / PI er sjef for Matrix).

[WernerVonHaussenberg]

@Laaarsas

Att byta riktning innebär såklart en ökad risk

Her benytter du stråmannsargumentasjon ved å tillegge selskapet en hensikt det ikke har. Det skal ikke “bytte” retning. De skal utforske en ytterligere retning, ved siden av det de allerede holder på med (og det har de forsåvidt gjort en stund, men det har ikke blitt snakka så mye om ennå).

Edit: Jeg skjønner virkelig ikke hvorfor du hopper til sånne konklusjoner.

[polygon]

Ultimovacs småprat

Har vært en del diskusjoner rundt KM plottene som vi nå har fått etter presentasjonen fra Helland. Som flere allerede har påpekt så er minste oppfølgingstid rundt 7 mnd. (data cutoff August), og det er ganske mange sensurerte. Disse kan enten være i live i August eller de har trukket seg fra studien. Vi vet ikke hvem som er hva, men vi vet de som er sensurert og i live vil kunne få en event ved senere oppfølging (jeg regner med pasientene vil bli fulgt opp videre). Tenkte å prøve illustrere hv…

[polygon]

@the1nonly

Edit: Forskjellen er fordi HR 0.8 er med 95% CI og HR 0.73 er med 80%CI.

Her skriver du nok noe feil. HR endrer seg ikke med forskjellige konfindensintervaller. HR er 0.73 uansett om konfidensintervallet er 95% eller 80%, det er bare bredden som endrer seg: HR of 0.73 (80% CI: 0.53-1.0, 95% CI 0.45-1.18).

De to forskjellige HR-verdiene er basert på to forskjellige analyser. En univariabel analyse er bare basert på selve KM-plottet. En multivariable analyse tar hensyn til alle andre data man har på pasienten ved baseline. Dette kalles også adjusted HR, og er hva som er standard å rapportere og skrive om. Når det bare står HR, så er det alltid adjusted HR som menes.

[the1nonly]

@polygon

Her skriver du nok noe feil. HR endrer seg ikke med forskjellige konfindensintervaller. HR er 0.73 uansett om konfidensintervallet er 95% eller 80%, det er bare bredden som endrer seg: HR of 0.73 (80% CI: 0.53-1.0, 95% CI 0.45-1.18).

Takk. Var opprinnelig ikke med, men plukket det opp fra chaten å la den inn i ettertid. Har kvernet på det i hele kveld fordi jeg ikke fikk det til å stemme med hvordan jeg har tolket Cox proportional hazards modell. Da var det slik jeg “egentlig” trudde, men ikke var trygg nok på å skrive.

[TekBot]

Ultimovacs Provides Complete Phase II NIPU Results Presented at ESMO 2023: Significant and Clinically Meaningful Improvement in Overall Survival for Patients with Malignant Mesothelioma Receiving UV1 Cancer Vaccine

• UV1, in combination with the checkpoint inhibitors ipilimumab and nivolumab
  from Bristol-Myers Squibb, met the study protocol’s predefined threshold for
  statistical significance and demonstrated a clinically meaningful overall
  …

Vis børsmeldingen

survival benefit with no added toxicities, compared to ipilimumab and
nivolumab alone, in the second-line treatment of patients with malignant
mesothelioma

• First demonstration of universal cancer vaccine efficacy in randomized Phase
  II clinical trial; Proof of Concept supporting further clinical development

• Webcast presentation by Principal Investigator Professor Åslaug Helland
  (https://www.esmo.org/about-esmo/biographies/aaslaug-helland), MD, PhD, and
  Ultimovacs management will take place today, Mon, Oct 23, 2023, at 14:30 am
  (CET). The slide presentation is attached to this announcement. The webcast
  can be accessed live or as a replay (link
  (https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20231023_2)).
  Company presentation, incl. NIPU data is available on the Ultimovacs
  website. (Presentations and Publications - Ultimovacs)

Oslo, October 23, 2023: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-
stage biotechnology leader in novel immunotherapeutic cancer vaccines, today
announced the full dataset from the NIPU clinical trial (NCT04300244
(CTG Labs - NCBI)) presented at the ESMO Congress
2023 in Madrid. NIPU is an investigator-initiated, randomized, multi-center,
open-label Phase II clinical trial for second-line treatment in patients with
malignant mesothelioma (MPM).

The data from the study was published initially
(NewsWeb) in a late-breaking abstract
(https://www.annalsofoncology.org/article/S0923-7534(23)04266-7/fulltext) at
ESMO. Further details have now been provided in an oral presentation by the
Principal Investigator at the ESMO Congress. The results showed that Ultimovacs’
cancer vaccine UV1, in combination with ipilimumab and nivolumab, demonstrated a
statistically significant and clinically meaningful improvement in overall
survival versus ipilimumab and nivolumab alone, a key secondary endpoint. No
additional safety concerns were reported from the UV1 treatment.

UV1 plus ipilimumab and nivolumab improved overall survival (OS), reducing the
risk of death by 27% (hazard ratio (HR)=0.73 [80% CI, 0.53-1.00], 1-sided p
value = 0.0985, 2-sided p value = 0.197). The median OS was 15.4 months (95% CI,
11.1-22.6) for UV1 plus ipilimumab and nivolumab (treatment arm) versus 11.1
months (95% CI, 8.8-18.1) for ipilimumab and nivolumab alone (control arm), with
a median observation time of 17.3 months. This degree of improvement met the
protocol’s predefined threshold for statistical significance.

The data further demonstrated a benefit in terms of objective response rate
(tumor reduction by at least 30%), as determined by blinded independent central
review (BICR). In the UV1 arm, 31% of the patients experienced an objective
response, compared to 16% in the control arm (odds ratio 2.44 [80% CI,
1.35-4.49], 1-sided p value = 0.028).

The baseline patient characteristics were well balanced between the two
treatment arms. The epithelioid subtype of MPM comprised 77.1% of the study
population, in line with the frequency of this subtype among the general MPM
population. Notably, the trial enrolled a relatively high fraction of patients
with PD-L1 negative tumor biopsies (53.4%), a characteristic for patients
typically less responsive to checkpoint inhibitors alone.

The safety profile of the combination of UV1 plus ipilimumab and nivolumab
observed in the trial was consistent with the safety profile of ipilimumab and
nivolumab alone, confirming the good safety profile for UV1. The patients will
continue to be monitored for efficacy and safety endpoints over the next years.

“The results from the first randomized UV1 Phase II trial, NIPU presented by the
Principal Investigator Professor Åslaug Helland at ESMO 2023, is a proof of
concept for UV1. These data reaffirm our unwavering commitment to developing UV1
as an effective add-on treatment to checkpoint inhibitors for a range of
cancers. We eagerly anticipate the forthcoming results from our other ongoing
Phase II trials and how these data will move us forward in our mission to
improve outcomes for cancer patients worldwide,” said Carlos de Sousa, CEO of
Ultimovacs.

The NIPU study is sponsored by Oslo University Hospital with support from
Bristol-Myers Squibb and Ultimovacs. The randomized, open-label, multi-center
trial with 118 patients was conducted in Australia, Denmark, Norway, Spain, and
Sweden. The trial enrolled patients with malignant mesothelioma after first-line
treatment with platinum-based chemotherapy. The first patient in the NIPU trial
was enrolled in June 2020, and the last patient was enrolled in January 2023.

The NIPU trial was designed to detect a clinically meaningful difference between
the two treatment groups and includes a statistical analysis plan typical for
randomized phase 2 trials where the aim is to assess efficacy without recruiting
a large number of patients. Both the study protocol and the statistical plan
were approved by the regulatory authorities. It was set up with 80% statistical
power and a 1-sided alpha of 0.1. This means we can be 80% confident that we’ve
accurately measured the effects of UV1. According to the trial protocol and the
number of patients included, the trial results are presented with 80% confidence
intervals and are considered statistically significant if the one-sided p-value
is below 0.1.

Ultimovacs announced topline NIPU study results in June 2023. Based on BICR, the
study did not meet the primary endpoint of PFS. Investigator assessment, a pre-
defined supportive analysis of the primary endpoint performed by specialized
radiologists at the study hospitals, showed a statistically significant positive
PFS benefit for the patients in the UV1 arm. The HR per BICR was 1.01 (80% CI
0.75-1.36, 1-sided p value = 0.4895, 2-sided p value = 0.979), with a median PFS
of 4.2 months (95% CI 2.9-9.8) for UV1 plus ipilimumab and nivolumab, and 4.7
months (95% CI 3.9-7.0) for ipilimumab and nivolumab alone. The HR per
investigator assessment was 0.60 (80% CI 0.45-0.81, 1-sided p value = 0.0125, 2-
sided p value = 0.025), with a median PFS of 4.3 months (95% CI 3.0-6.8) for UV1
plus ipilimumab and nivolumab and 2.9 months (95% CI 2.4-5.5) for ipilimumab and
nivolumab alone.

In October 2023, Ultimovacs announced that the U.S. Food and Drug Administration
(FDA) had granted Orphan Drug Designation for UV1 in the treatment of
mesothelioma (based on the NIPU data from June 2023).

UV1 is a therapeutic cancer vaccine that generates an immune response against
the human telomerase (hTERT) enzyme. The enzyme is essential for the ability of
cancer cells to proliferate. Telomerase is present in 85-90% of all cancers,
across the stages of the disease. The vaccine is manufactured as an off-the-
shelf product with a long shelf life. UV1 is easy to use and does not require
sophisticated hospital infrastructure, enabling patient access to therapy also
in community centers, and in rural and underserved communities.

Ultimovacs is evaluating the universal cancer vaccine UV1 in a broad clinical
development program across various cancer indications with different biology and
disease stages, in combination with different checkpoint inhibitors. The topline
data from NIPU are the first results among the five randomized trials in the UV1
Phase II clinical program. In addition to malignant mesothelioma, Phase II
studies are ongoing in patients with malignant melanoma, head and neck cancer,
ovarian cancer, and non-small cell lung cancer. The topline data from the
malignant melanoma and head and neck cancer trials are expected during the first
and second half of 2024. UV1 is a patented, proprietary technology owned by
Ultimovacs.

                                ==ENDS==

About NIPU
NIPU (Nivolumab and Ipilimumab Plus/minus UV1 vaccination) is a randomized,
multi-center phase II trial in which Ultimovacs’ universal cancer vaccine, UV1,
is evaluated in combination with Bristol-Myers Squibb’s checkpoint inhibitors,
nivolumab and ipilimumab, as second-line treatment of malignant mesothelioma.
The trial sponsor is Oslo University Hospital, supported in the preparation and
execution of the trial by Ultimovacs and Bristol-Myers Squibb.

The 118 patients were randomized 1:1 into two treatment arms. All participants
receive treatment with nivolumab (240 mg every two weeks) and ipilimumab (1
mg/kg every six weeks) until disease progression, unacceptable toxicity, or for
a maximum of 2 years. Patients randomized to the experimental arm received eight
intradermal injections of UV1 vaccine during the first three months of
treatment. The objective of the study is to achieve a clinically meaningful
benefit in patients with malignant mesothelioma (MPM) after progression on
first-line standard platinum doublet chemotherapy. Subsequent events emerging in
patients in both arms of the NIPU study will continue to be monitored beyond the
read-out of the primary endpoint. The ipilimumab and nivolumab combination has
recently been approved as first-line treatment for patients with malignant
pleural mesothelioma in Europe and the U.S.

The trial was sized to detect a target PFS HR of 0.6, with 80% power and a 1-
sided alpha of 0.1. Overall survival was calculated using the same method as for
PFS.

About Mesothelioma

Malignant mesothelioma is a rare and aggressive type of cancer that occurs in
the thin layer of tissue surrounding the lungs and inside of the chest.
Mesothelioma accounted for 30 870 new cancer cases and 26 278 cancer deaths
worldwide in 2020, according to the International Agency for Research on Cancer
(Globocan 2020). Mesothelioma is a disease with a high unmet medical need,
especially in industrialized countries. The median overall survival is
approximately one year. Occupational asbestos exposure is the No. 1 cause of the
disease, and several occupations like firefighters, military veterans,
construction, and industry workers, are at risk. This cancer usually takes
several decades to develop after a person’s first exposure to asbestos. Most
patients are diagnosed after age 70 because of the long latency period. Even
though the use of asbestos to a large extent is banned in new constructions in
many countries today, new incidences of mesothelioma will continue to be a
medical and public health challenge because of the long latency period typical
of the illness. Few treatment options are available after first-line
chemotherapy for patients with inoperable disease. The combination of ipilimumab
and nivolumab has recently shown increased survival compared to standard
chemotherapy, but most patients do not respond, and improvements are called for.
Telomerase is expressed in mesothelioma cells and is therefore a relevant target
for therapeutic vaccination.

About Ultimovacs

Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic
cancer vaccines with broad applicability. Ultimovacs’ lead cancer vaccine
candidate UV1 is directed against human telomerase (hTERT), an antigen present
in 85-90% of cancers in all stages of tumor growth. A broad clinical program,
with Phase II trials in five cancer indications enrolling more than 670
patients, aims to demonstrate UV1’s impact in combination with other
immunotherapies in multiple cancer types expressing telomerase and where
patients have unmet medical needs. UV1 is universal, off-the-shelf, and easy to
use, and is a patented technology owned by Ultimovacs.

In addition, Ultimovacs’ adjuvant platform, based on the proprietary Tetanus-
Epitope-Targeting (TET) technology, combines tumor-specific antigens and
adjuvant in the same molecule and is in Phase I clinical development.
The Company is listed on Euronext Oslo Stock Exchange (ULTI.OL).

About the UV1 Phase II program

The immunotherapeutic cancer vaccine UV1 is investigated in combination with
checkpoint inhibitors in patients with various cancer indications with diverse
tumor biology. The diversity of the UV1 Phase II program places Ultimovacs in a
favorable position to capture the cancer vaccine’s potential broad applicability
when combined with checkpoint inhibitors:

• INITIUM: Evaluating UV1 in combination with ipilimumab and nivolumab as
  first-line treatment for patients with malignant melanoma. Enrollment of
  156 patients completed, expected readout H1 2024. Sponsored by Ultimovacs.
• NIPU: Evaluating UV1 in combination with ipilimumab and nivolumab as second-
  line treatment for patients with malignant pleural mesothelioma. Enrollment
  of 118 patients completed, the results were presented at the ESMO Congress
  in October 2023. The investigator-initiated study is led by Oslo University
  Hospital and supported by Bristol-Myers Squibb and Ultimovacs.
• FOCUS: Evaluating UV1 in combination with pembrolizumab as first-line
  treatment for patients with head and neck cancer. Enrollment of 75 patients
  completed, expected readout H2 2024. The investigator-initiated study is led
  by Halle University in Germany, supported by Ultimovacs.
• DOVACC: Evaluating UV1 in combination with olaparib and durvalumab as
  maintenance therapy in non-BRCA mutated patients with advanced ovarian
  cancer. >20% of 184 patients enrolled as of Q2 2023 reporting, expected
  readout H2 2024. The investigator-initiated study is led by NSGO-CTU and
  supported by ENGOT, AstraZeneca, and Ultimovacs.
• LUNGVAC: Evaluating UV1 combined with cemiplimab as first-line treatment of
  non-small cell lung cancer patients. <10% of 138 patients enrolled as of Q2
  2023 reporting, expected readout H2 2025. The investigator-initiated study
  is led by Vestre Viken (Drammen Hospital) and supported by Ultimovacs.

About UV1

UV1 is a universal cancer vaccine designed to induce a specific T-cell response
against telomerase. UV1 consists of long, synthetic peptides representing a
sequence in the reverse transcriptase subunit of telomerase (hTERT), shown to
induce CD4+ T-cells. These CD4+ T-cells have the potential to provide
inflammatory signals, and T-cell support is believed to be critical for
triggering a strong anti-tumor immune response. Following intradermal injection,
antigen-presenting cells (APCs) in the skin are exposed to the vaccine peptides.
These APCs will process the peptides and present vaccine epitopes on Human
Leukocyte Antigen (HLA) molecules to naïve T-cells in the lymph nodes. Activated
vaccine-specific T-cells will then enter the circulation and search for cells
displaying their cognate antigen in the context of HLA molecules.
The UV1 peptides contain several epitopes, shown to be non-restrictive in terms
of (HLA) alleles for presentation. It is, therefore not required to perform HLA
pre-screening of patients, which potentially enables broad population
utilization of the vaccine. UV1 is administered over three months with eight
intradermal injections and the immune-modulator GM-CSF.

A link to the webcast and the comprehensive results from the NIPU study may be
accessed from the Company website www.ultimovacs.com
(http://www.ultimovacs.com). For further information, please contact:

Carlos de Sousa, CEO
Email: carlos.desousa@ultimovacs.com (mailto:carlos.desousa@ultimovacs.com)
Phone: +47 908 92507

Anne Worsøe, Head of Investor Relations
Email: anne.worsoe@ultimovacs.com (mailto:anne.worsoe@ultimovacs.com)
Phone: +47 90686815

This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to Section 5-12 in the Norwegian Securities Trading Act.
This stock exchange announcement was published by Anne Worsøe, Head of Investor
Relations at Ultimovacs ASA, on October 23, 2023 at 07:00 CET.

Kilde

[Birgitte]

På tide å bli ferdig med NIPU.

Den har gjort jobben - levert POC og vist at UV1 fungerer. Men NIPU - er fortsatt den “svarte andungen” hos U fordi den kom skjevt ut i juni og dette henger i ennå på børsen.

På tide og se fremover. INITIUM news om ca 2 uker på Q3.
Litt status:

Initium er langt på overtid.

Avlesning etter oppnådde 70 events har ikke inntruffet.

Carlos sa på dagens presentasjon:
“Pasientene får ikke lenger progresjon og dør ikke.”

Gjennomsnittlig oppfølgning nå er ca 23, 5 mnd. 2 år på Q3 presentasjonen.
Siste pasient ble innrullert i juni 2022 dvs for ca 16 måneder siden.

Når vi vet følgende:

1. CM67 kontrollstudien har en mPFS på 11,5 mnd.(11,7)
2. I senere sammenlingbare studier under covid parallelt med Initium har mPFS vært kortere enn CM67.
3. Studier gjennomført under covid har ikke resultert i større frafall, jfr innlegg her på tråden 1957 fra Polygon.

Sannsynligheten for at UV1 i Initium vil levere sensasjonelle signifikante resultater er nå meget høy.

Kjetilaaj - det hadde vært fint med oppdaterte diagram og grafer i Initium. Please.

Henter fram et plott fra Bobblegutten sitt innlegg nr. 1139 her på tråden.

Et mulig senario med tenkt avlesning 03. september 2023. Nå vet vi at det ikke engang blir avlesning 03. november 2023.

Bobblegutten:
"For det siste plottet er det filtrert på p-verdi 0.008 – 0.004, altså et helt vanvittig resultat. For en slik frisk populasjon vil dette da drøye en del.

Et helt ekstremt resultat, hazard ratio under 0.50. Veldig sen avlesningsdato.

[Hod]

Dette innlegget ble rapportert og er midlertidig skjult.