De Monitor schreef op 27 oktober 2019 13:33:
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Voordat je iets 'zever' (wat dat ook moge zijn) noemt is het misschien handig je feiten te checken. Dan zul je zien dat het je onderbuik gevoel is en geen feit.
Het gaat om een fase II studie, absoluut GEEN fase III in welke hoedanigheid dan ook. Pharming noemt het een IIb, maar dat is een niet bestaande fase die Pharming verzonnen heeft om het wat positiever te laten lijken door de eerdere fase II studie in Basel.
Misschien dat het Basel onderzoek de tijdlijn iets kort, maar er is absoluut geen sprake van een fast-track!
Volgende keer echt even je feitjes checken alvorens je dingen gaat beweren, die door meerdere leden weerlegd worden middels een bron.
Zie de eerdere toelichting van Bassie:
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And of course, a very important, we already had some data in this. We had a -- I might remind you last year, we had the so called Basel study, we had very positive results from a Phase II properly designed 80 patients, double-blind placebo-controlled investigator study by Professor Gustaaf in Basel and with patients at risk of nephropathy resulting from these contrast and [use] [ph] determination.
And we found a statistically significant effect in reducing angle which was the primary endpoint for the study in patients undergoing, especially in patients undergoing the PCI, the percutaneous coronary interventions. So, that is why on the basis of this data, we decided to move forward with a formal phase --
I will call it a Phase IIb study, where we will be looking at various dose and regimens of Ruconest in those patients, those group of patients undergoing the PCI procedures. And we have indeed the attention that we foresee to be able to start taking the trial of course subject to approval, the regulatory authorities, I must say here, we
foresee to be able to start this Phase II trial. Later on towards the end of this year to prevent acute kidney injury in patients undergoing PCI, and again, will be led by Professor Gustaaf in Basel, we will be liking having some 5 to 6 edges in Switzerland and Germany possibly also participating. And at this point in time, we are looking as there'll be a much bigger study than last time, it will be about 160 and we proceed to have probably three dose arms and the placebo arm. We'll be again measuring angles the primary endpoint as well as of course create more classical measures of the renal impairment such as creatinine and we will be having and that's in contrast last year's study also of course a six month follow up to assess the long-term effects of this.