Ante ikke at norske webcasts ble transkribert, dette er jo gull!
Jeg var jo interessert i “why no FPD”, dette beroliget meg. @vegar_beider :
Unidentified Analyst, [8]
I have another question. It’s regarding the PARADIGME study. It has been quite a long time since the first sites of PARADIGME was opened for recruiting. So far, no patients have been recruited. Could you please clarify something around what we are waiting for? Is it harmonizing of the protocols between the countries or what are we waiting for?
Lisa Rojkjaer, Nordic Nanovector ASA - Chief Medical Officer [9]
Yes, I’d be happy to do that. So the first center actually opened last week of February. And since then, these sites have been – so – opening rather gradually, so some of the sites haven’t been opened that long. And actually, when you look at oncology studies, it can take a little bit longer to enroll the first patients because the patients have relapsed disease. So if you look at the disorders like hypertension or diabetes, arthritis, it’s easier to kind of line up patients. We can’t sort of do that in this study. I think that we’re still maintaining the guidance to have the first patient in by the end of June. I think we also need to really work on getting as many sites open as quickly as possible. I think this is really key to the success of the enrollment of the study because there are going to be a variety of sites, big teaching centers, smaller hospitals, so we will see that the patient enrollment rates will also vary according to the centers that are open. So now it’s still early days so, yes.
Et bøttekott i Ungarn vil ikke nødvendigvis ha riktige pasienter tilgjengelig i løpet av et par måneder. Nøkkelen til hastig enrollment er å være tilstede der hvor pasientene passerer igjennom systemet. Usa er viktig:
Again, I’ve mentioned that the protocol has been reviewed by the FDA, and the sites in the U.S. are expected to be open midyear. And the sites selected are clinical centers of excellence in the treatment of NHL and hematologic malignancies, so we expect to get high-quality data and the relevant patient population from these centers, centers that are well experienced in doing clinical trials.
Og antall sites er viktig:
We’re maintaining guidance on having the first patient dosed by the end of next month. As of yesterday, we had 23 sites in 8 countries that are open for enrollment. Probably by tomorrow, that number might change a little bit. Things change every day now because we’re in a very active phase of – and our priority #1, 2 and 3 is really getting the – as many sites as possible open for enrollment as quickly as we can.
For meg virker det som om nano er på ballen!
Okay, we have Ludvik somewhere here as well. Maybe you want to join? No? Okay.
