En av diskusjonene de hadde på Radium var blant annet dette med at en pasient fra en av de lavere kohortene med lav dose var tatt med i gjentakende behandling. Denne pasienten levde fortsatt og hadde da fått høyere dose istedet for den tidligere mer eller mindre placebo dosene. Usikker på om det er dette dere referer til? Isåfall så er det pasient fra de lavere kohortene som er tatt med i extension studien hvor en da får høyere dose.
I’m not referring to this because this patient with repeated treatment is from corhort 2 and this was done before even starting extension study as this was an initiative from the investigator/doctor involved in phase 1 safety and efficacy study.
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So no patients from the past cohorts are to be included in the extension study? Meaning at most 12 new patients will have to be recruited and treated with two cycles of the firmachem regime?
What is the estimated time from start of treatment untill safety readout for a patient in the extension study?
This revision to the treatment protocol was published 2,5 months after the first patient was dosed with the first treatment which means 2weeks before the same patient is due for the second treatment, is this a coincidence???
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Fra rek vedtaket i juni i fjor:
"6) Det er gjort endringer i fase II delen som omfatter inkludering av en komite for å monitorere sikkerhet og effekt underveis i studien. "
Hvis jeg leser dette rett er det allerede søkt om og godkjent en fase II del, altså den pivotale fasen. Hvis jeg husker rett mente Glein at de måtte søke separat om fase II og dette ville ta tid. Slik jeg tolker dette stemmer ikke det, studiet det er søkt om er et fase I/II studie, så PCI har vært smarte der for å ikke å tape tid på søknadsprosesser.
Sitatat ovenfor er interessant i seg selv, fordi det undrestreker muligheten for accelerated approval basert på løpende monitorering av effekt.
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Ved evnt endringssøknad til REK gjelder ikke de frister som framgår av REKs hjemmeside, de gjelder kun nye prosjekter. Forhåpenlig kan små endringer, feks at det blir 1 eller 2 behandlinger, behandles raskt og utenom ordinære komitemøter.
https://helseforskning.etikkom.no/frister/soknadsfrister?p_dim=34667
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Tolker kanskje litt mye inn her
Well, There has to be an assessment before the applucation for amendments/changes to the treatment protocol, the application has to be written and sent and this has to be assessed by the comittee and published. I guess this will take some time, and if so, the changes May very well not be Linked to the actual situation of patient 1. If that is what worries you.
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My short answer on your question is that all changes are minor and have no impact on the the projections, those are clarifications.
If the extension study is a part of the original dose escallation or not will not have an impact on PF2 as the pivotal study is a randomised study. Because it is randomised it is a stand alone study.
Anyway, my clear understanding of this is that the extension study is an expansion of the original dose escalation, and that it is defined as dose escalation.
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Thanks Snøffelen,
and yes PW confirmed that patients from extension study will not participate in PF2 as this will have to be randomized, this was during q1 presentation in March webcast QA session, during the same QA session there was an interesting discussion on criteria for pricing single vs multiple treatments including comments from jonas einarsson, recommend investors to listen to it
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PCI Biotech: Invitation to first half year 2018 presentation
Oslo, 23 August 2018 - PCI Biotech invites to a presentation of the company’s second quarter and first half year 2018 report on Thursday 30 August 2018 at Oslo Cancer Cluster Innovation Park.
Time: Thursday August 30, 08:30am . 09:30am CEST (local time).
Venue: Jónas Einarsson aud. (2nd floor, entrance 2B), Oslo Cancer Cluster Innovation Park, Ullernchausséen 64, OsloThe presentation will be held in English and if you wish to attend the presentation, please confirm with an e-mail to post@pcibiotech.com.
The presentation will also be a live audiocast and can be accessed through www.pcibiotech.com. It will be possible to post questions through the audiocast console.
The interim report and the presentation will be available on www.newsweb.no and on the company’s webpage, www.pcibiotech.com from 07:30am (CEST) on 30 August 2018.
For further information, please contact:
Ronny Skuggedal, CFO
Email: rs@pcibiotech.no
Mobile: +47 9400 5757
Nyheten er levert av GlobeNewswire.
http://www.netfonds.no/quotes/release.php?id=20180823.GlobeNewswire.GNW1000096625-en
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Does anyone think we might actually get safety for the extension study in the H1 presentation. PCI have a bit of a habit of slipping out some info in quarterly presentations. If I remember correctly, response at the single lesion level for cohort 3 and 4 was released via a quarterly presentation.
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I belive we do, that and some other precious intel ! 
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Tweet fra Radforsk idag;
Vi hører fra lyttere av podkasten #Radium at dere har abstinenser etter nye, “vanlige” episoder. Det har vi og, så neste uke starter vi innspillingen fra studioet vårt i @OsloCancer Innovasjonspark m nye dyktige Ullern-elever som produsenter. Ny innspillingsdag blir onsdag 
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Jeg har ikke noe stort håp om oppdateringer bortsett fra oppdaterte OS tall fra de siste gjenlevende. Disse tallene har aldri vært kursdrivende så vi kommer nok til å vake rundt femtilappen til vi får pf2 og finansiering i orden.
Men det hadde selvsagt vært fett med resultatet fra gjentakende 
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Pci opportunity in veterinary medicine
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The list seems endless regarding usage of PCI 
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Pci is mentioned here in this q-1 2018 FCF life science monitor from Germany, quite a good read as it maps biotech industry in Europe and also helps screening potential investment across the continent.
Pci biotech is mentioned under therapeutic-small from page 29. And it states that expected profibility > 2021
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Stock DZ,
your latest reference opens a vision of another shareholder structure some weeks after the big decisive questions are settled. The majority of the top50 (and I guess even more so when it comes to top100) are private investors with limited resources to defend their share of the company in the long run.
… which means that the ones from the “old family” (the settlers) could end up disgustingly rich even if they only could put aside 10k or more.
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