Diskusjon Triggere Porteføljer Aksjonærlister

PCI Biotech - Småprat 2019 (PCIB)

??? Jeg selger mye?? Det er vel ikke mange her på forumet som spiller med så åpne kort som meg. Jeg har 150k som “base” i PCIB og så “støttekjøper” jeg ofte 15k om jeg synes vi har ramla for mye og der tar jeg gev uten å presse ned kursen. Jeg er aktiv i andre aksjer ja. Tok gev på Gjensidige-shorten min i dag ( litt for tidlig men 4 kr på 5k aksjer ble da brutto 20k)

2 Likes

Ok. Takk for svar. Jeg har sett en person har kommentert dette mer enn to ganger. Så jeg har bare hengt meg opp i dette, men dette er jo et anonymt forum.

Jeg har null kompetanse til å skrive noe om det faglige i PCIB men har faktisk litt peiling på kjøp/salg av aksjer så mitt bidrag blir på den siden. ( godt ment)

5 Likes

Nok et land med godkjennelse i Europa, Finland, hvilket betyr at 9/11 i land i Europa er godkjent og 10/12 land totalt:

https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-002647-29/FI

Vi har følgende status for RELEASE per idag (her kan det være kommet aktiveringer og godkjennelse som vi ikke vet om, så det er minimumstall).

2019-10-23_10-53-00

36 Likes

Shorting er én ting, Arve, men kursmanipulasjon er noe annet.
Slik Folketrygdfondet har opptrådt en rekke ganger i NANO, gjerne i forkant av nyheter, gjør at jeg blir skeptisk til om det som foregår er helt fair play.

Noen ganger får jeg følelsen av at noen vet mer enn andre og får nyheter noen dager tidligere enn andre, og kan agere deretter.
Det er i hovedsak dette jeg misliker med shorting. Ikke shorting i seg selv, for det er jo greit, det er kun et veddemål.

Problemet oppstår når størrelsen på shortingen er såpass stor i forhold til dagsomsetningen at shorten i seg selv bidrar til å presse kursen nedover.

6 Likes

Fra BørsXtra - lenken til sendingen på tirsdag: https://www.facebook.com/Xtrainvestor/posts/10158068979296495

De ber om at spørsmål vi måtte ønske å få svar på eller kanskje de vi vil at markedet generelt skal lære seg snarest mulig sendes til info@xtrainvestor.com. For de som ikke er på Facebook skal de rett etterpå legge ut opptak på YouTube.

4 Likes

Noen som fikk hørt på denne, og ble det stilt noen gode spørsmål?

Nyhetene fra PCIB lar tydeligvis vente på seg…

PCI Biotechs CEO Per Walday kommer til oss i et Q&A event tirsdag 29.oktober kl 1300.

Nyhetene venter helt til 29 okt, Lothian! :crossed_fingers:

5 Likes

Det er samme dag som godeste Anders Høgset skal presentere på World Vaccine Congress :slight_smile:

2 Likes

Takk for den. Hadde blingset på datoen, men PCIB kan få lov til å sende en børsmelding med positive nyheter i dag, før og etter 29. oktober :slight_smile:

3 Likes

Does someone in here know why we still haven’t opend any sites in US yet? My fear is that this means slower recruitment, but it also raises questions towards the adaptability of the technology at the US hospitals - “lazer” technology and chemotherapy could easily be thought of as “outdated” threatments. I also believe that this is partly the reason why no real institutional investors have yet bought PCIB.

Anyonne have the same concerns? I hope that the treatment will show superiority - untill then investing in PCIB could be “dead money”.

Skriv på norsk du Albinoen, mistenker at den er bedre enn engelsken din? :thinking:

I really do not understand your worries Regards to your question of US acceptance. Regulatory and ethic approval granted in the US!

Transcript from latest Q (Q2):

https://finance.yahoo.com/news/edited-transcript-pcib-ol-earnings-221634918.html

So summarizing this. The pivotal study is progressing well. We had our first patient included in May. Recruitment is progressing according to plan. We have achieved safety endpoint in the extension study, the RELEASE initiated now – has been initiated now with up to 2 treatments. Regulatory and ethic approvals are progressing according to plan. By mid-August, we had approvals received for the U.S., which is important, of course, and 8 of the 11 planned European countries. That included Norway, Germany, France, Spain, Belgium, Poland, Sweden and Denmark. We’re still waiting for Finland, U.K. and Italy. So those are the 3 remaining.

Site initiations progressing according to plan with a total of 15 sites across 7 European countries open for enrollment and actively screening for patients now by mid-August. It’s been a lot of work over the summer of this PCI Biotech organization, the operational team. And I would like to use this opportunity to congratulate them on the good work that they’ve done actually because it’s been a lot of work during the summer.

And then we have had presentation of Phase I data at the CCA Foundation in Salt Lake City at the Asia Pacific CCA conference in Taipei, in Taiwan and also the International Photodynamic Organization World Congress (sic) [International Photodynamic Association World Congress] in the U.S. in June 2019. We were – I was present myself at the International Photodynamic Association World Congress in June where we were a sponsor of the meeting. We had separate seminar, which was very well attended and with a lot of questions and interaction with the audience. So there is a lot of interest in the technology.

Looking forward then, what are we doing? What is the pivotal study. It’s a randomized study, 1:1, with an interim analysis for a potential accelerated approval. We have orphan designation by regulatory authorities, EMA and FDA, granted in both U.S. and EU. The fastest way to market has been determined through regulatory interactions with both of those agencies and this is the result of those interactions. We can, with this, become a first-line treatment of patients with inoperable extrahepatic bile duct cancer by doing randomization study of 1:1 with approximately 186 patients. The primary end point being progression-free survival and overall survival, of course, as a key secondary in this population which has very poor survival. And then potential accelerated approval through interim analysis of primary endpoints PFS, progression-free survival, followed by objective response rate. And we are planning to do this in approximately 40 key hospitals across Europe and the U.S.

Now I mentioned also that the prevalence of this disease in Asia is higher than it is in the Western world. So it is an area where we need to have a presence and where we can actually speed up recruitment. So we have a feasibility study ongoing in Asia to select the most appropriate RELEASE study sites for patient recruitment and market impact, and the aim is then to open sites in Asia as well in 2020. It’s still in a feasibility study, so it’s too early to talk too much about which countries and how many sites and so on, we’ll have to come back to that one of the feasibility is done. But this is the aim: to open study sites in 2020. So that was fimaCHEM.

From Q&A session:
Now looking forward, we are planning to have the first – we are now – we have the approvals in the U.S. and we are now doing the contract negotiations with the different sites in the U.S., which is what normally takes the longest time in that country. As you all know, there’s a lot of contract things around U.S. Probably – there’s a lot of contract issues around U.S. and contract – lawyer food you can call it maybe in – specifically that area of the world. So that normally takes the longest time, but we hope to have our first U.S. patient enrolled in the pivotal cancer study this autumn.

7 Likes

Og PCIB har vel tidligere indikert at FPD i USA vil bli børsmeldt?

2 Likes

Finland ble godkjent tidligere denne uken!

3 Likes

Det er blitt guidet H2, så jeg tenker at første innrullerte pasient i USA kommer innen H2 er omme.

Jeg går ut ifra at du mener mener “laser” technology.

Jeg har aldri tenkt at chemo er en utdatert teknologi, kan du utdype hvorfor du mener at det kan bli oppfattet som det?

Laserteknologi høres jo i all fall fancy ut, så her er det også fint om du utdyper hvorfor du mener det er utdatert.

Og hvorfor skal det oppfattes som utdatert i USA, men ikke i Europa?

SoC er jo forøvrig Chemo, så jeg tenker at de bruker det, selv om det oppfattes som “utdatert” i følge deg. Hva annet skal de behandle pasientene med?

Jeg kan jo også si hva jeg tenker. Jeg tror sykehusene er mest opptatt av hva som fungerer best på inoperable GKK, ikke hva slags teknologi som blir benyttet. PCI+Chemo er i så måte interessant å teste mot SoC, gitt de lovende resultatene PCIB kan vise til (de får de jo uansett SoC, som er en trygghet i seg selv).

12 Likes

The Laser u are refering to is called :
Photochemical internalization (PCI) is a drug and gene therapy delivery method originally developed to improve the release of macromolecules and hydrophilic chemotherapeutic agents from endosomes and lysosomes to the cytosol of targeted cancer cells.

i have one sentence for u taken from a Nordic life science magazine last mounth

PCI Biotech - On the cusp of a revolution in cancer treatment
- Precision Cancer Treatment, Nucleic acids, Vaccines and Chemo therapy -

10 Likes

Hadde jeg sittet på gjerdet,ville jeg definitivt hoppet ned og posisjonert meg før tirsdag🤘

1 Like

Hva tenker du Høgset kan si i Barcelona eller Walday kan fortelle oss her i Oslo på tirsdag som vi ikke allerede vet?

1 Like

Generelt er det bra med en oppfriskning, hva som blir sagt,vet ikke jeg… men mye kan en lese mellom linjene, stesielt på siste post med per!!!
Han virker Veldig sikker…
Noe kommer🤘

1 Like