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.
