Sør-Korea gav i dag klarsignal. 52 millioner mennesker der.---Akkurat hva "markedet" i Norge synes , er forsåvidt av liten interesse. 6 prosent opp betyr ingen verdens ting imot det som kommer.

Soul i S.Korea fungerer som et senter for helse-turisme i Asia fordi de ligger medisinsk meget langt fremme. Bla. mange Kinesere som reiser dit for å få den beste behandlingen.

Dessuten ODD i S. Korea vil være retningsgivende for andre asiatiske land som Taiwan hvor PCIB også er inne på flere sykehus med i sin gallegangs-studie.

Tar med dette innlegget fra Snoeffelen i dag, hvor han har funnet ut at ODD i S. Korea betyr så godt som godkjenning om man ser på statistikken:

"Virker som et løsner skikkelig i Sør-Korea for PCIB, og Oprhan Drug Designation der er virkelig en gledelig nyhet. Og grunnen er en statistikk som er ganske spesiell, og det er at i Sør-Korea så ser det ut som om ODD =Approval.


PubMed Central (PMC) 5

Patient Accessibility and Budget Impact of Orphan Drugs in South Korea:... 5
This study aimed to identify orphan drug accessibility and impact on pharmaceutical budgets in South Korea by analyzing the status of orphan drug designation, approval, reimbursement, and pharmaceutical expenditure. We analyzed the dataset on orphan...

“From 2007 to 2019, designated ODs and approved ODs were 165 and 156”

I vesten er jo ODD en super nyhet, men oddsen, for å si det slik er annerledes, og ODD er ingen garanti for approval."

Oslo, 28 May 2021 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company today announced that the Ministry of Food and Drug Safety (MFDS) in South Korea has granted Orphan Drug Designation to its lead product candidate, fimaporfin, for combination treatment with gemcitabine in patients with inoperable locally advanced or metastatic bile duct cancer (cholangiocarcinoma). No approved treatment alternatives exist today for the first-line treatment of patients with this disease and fimaCHEM (fimaporfin) has the potential to play a role in this area of high unmet medical need.
“The RELEASE trial has in general shown promise with good recruitment activity in South Korea despite the Covid-19 pandemic. Receiving orphan status from the South Korean authorities is a key step in the development of this important new medicine for Asian cancer patients in need of better local treatments. PCI Biotech’s fimaCHEM treatment is well suited for treatment of bile duct cancer, with easy light access through routine endoscopic methods.” said Dr. Per Walday, CEO of PCI Biotech. “Orphan designation in South Korea, in addition to the already granted orphan designations in EU and USA, are all significant regulatory milestones and recognises the therapeutic benefits we seek to bring to the patients.”
Contact information:
Per Walday, CEO
pw@pcibiotech.com
Mobile: +47 917 93 429
About bile duct cancer and the fimaCHEM technology
The bile duct drains bile from the liver into the small intestine. Bile duct cancer (cholangiocarcinoma) is a cancer that affects the cell lining of the bile duct and represents a patient population with a high unmet medical need. Surgery is the only potential curative option for these patients, but most patients are inoperable at presentation. Inoperable patients are treated with stenting to keep the bile duct open and with chemotherapy. Median survival of inoperable patients is between 11 and 12 months with the current standard of care treatment, which is a chemotherapy combination of gemcitabine and cisplatin. Biliary tract sepsis, liver failure and/or malnutrition and cachexia due to locoregional effects of the disease are the most important causes of death, so there is a high need for better locoregional treatments. The locoregional anti-cancer effect of gemcitabine is significantly enhanced by the fimaCHEM technology in preclinical studies, and early clinical treatment data suggest encouraging tumour response and survival in bile duct cancer patients.
Bile duct cancer is a rare disease with an incidence rate of 1-2 per 100,000 in the western world. The incidence rates are increasing worldwide and are generally higher in Asian countries. The immediate target for PCI Biotech is first-line treatment of inoperable patients with extrahepatic disease. The fimaCHEM treatment regimen consists of an intravenous injection of fimaporfin, followed four days later by an intravenous infusion of gemcitabine and a laser light application in the bile duct easily administered through endoscopic methods used routinely in these patients. The patients then follow the standard background treatment with up to 8 chemotherapy cycles of gemcitabine + cisplatin. The fimaCHEM treatment may be repeated during the background chemotherapy treatment cycles.
About PCI Biotech
PCI Biotech is a biopharmaceutical company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform. PCI is applied to three distinct anticancer paradigms: fimaCHEM (enhancement of chemotherapeutics for localised treatment of cancer), fimaVACC (T-cell induction technology for therapeutic vaccination), and fimaNAC (nucleic acid therapeutics delivery).
Photochemical internalisation induces triggered endosomal release that is used to unlock the true potential of a wide array of therapeutic modalities. The company’s lead fimaCHEM programme consists of a clinical Phase I/II clinical study in bile duct cancer, an orphan indication with a high unmet need and without approved products. fimaVACC applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines, which works in synergy with several other state-of-the-art vaccination technologies. fimaNAC utilises the endosomal release to provide intracellular delivery of nucleic acids, such as mRNA and RNAi therapeutics, thereby addressing one of the major bottlenecks facing this emerging and promising field.

For further information, please visit: www.pcibiotech.com
Forward-looking statements
This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements. PCI Biotech disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

Hvis det i Korea er LOA=94,5% (156/165) bør dette forklares til markedet for å få fart på kursen.

Neida , slett ikke drøvtygge for slike som ikke greier å forstå..... Hvis du ikke skjønner , så er det din egen skyld

Dette blir å koke suppe på en rusten spiker.
Når PciB allerede har fått ODD i både Statene og Europa ville det vært en sensasjon om de ikke fikk det i S-Korea

Nå legges opp til en PCIB-vaksine i kombinasjon med en checkpoint hemmer-CPI i partnerskap med et BP som er de eneste som er eiere en CPIèr.
Dette bør ha potensiale til å bli gigantisk!

"https://finansavisen.no/nyheter/helse/2021/05/31/7681727/pci-biotech-far-patent-i-usa

Jo man må nå nesten snu negativ kritikk til ros til ledelsen i PCIB som denne skriver:

"Det har vært mye tyn (forsåvidt med rette) til PCI og PW etter AZ-overraskelsen ifjor.

Med utviklingen den siste perioden; både ansettelser, ODD, samarbeid og patenter så virker den linjen de har lagt seg på i børsmeldinger å være veldig god. Hadde de meldt om alt mulig for å blidgjøre sulteforete aksjonærer (oss) så hadde kanskje de siste glimrende meldingene “druknet”.

Med tanke på hvor solid selskapet/teknologien/patenter er så skal vi ikke se bort i fra at PCI i flere settinger har takket nei til dårlige avtaler både på Chem, Vacc og Nac, rett og slett fordi de har ståltro på egen plattform. På kort sikt til frustrasjon for utålmodige aksjonærer, men på lang sikt er dette gull.

Å bygge et bunnsolid, bredt og sikkert fundament er kjedelig og tar tid, men desto mer solid og høyere kan en bygge. Og PCI bygger.

Strategien er non/semi-eksklusiv utlisensiering og partnere. Ikke salg av selskapet (som enkelte virker å tro/ønske).

Poenget mitt er at all den tid PW og PCI har fortjent tyn tidligere så viser de nå at de fortjener støtte og tillit."

Er det noen som har en kommentar til en eventuell konkurranse mellom PciB og Ultimovacs sin kombinasjonen med cpi?

Ja, ser at den kanskje kan komme.
Men enda alt for tidlig da vi vet minimalt om hvordan PCIB har tenkt sitt studieopplegg.