Thank you JP
The randomised trial plans for 80 patients so 40 in each arm unless its 2:1
The primary outcomes are safety and Local Disease Control at 16 weeks and its set for 18 month followup. All the secondary outcomes look excellent too.
The study looks like it will be based in Verona: details of the Centre here
http://www.chirurgiapancreasverona.it/?page_id=1975&lang=enIt looks to be an Italian national centre of excellence for pancreatic cancer with relatively big numbers, so hopefully recruitment will be OK. Not sure if its multicentre or single centre.
This is their first RCT. If positive, it will get them a label extension in Europe. And, it will probably convince TGA here. It looks like the company has decided they will push on with local disease control at 16 weeks as their primary outcome for major registration studies. Hopefully this is on advice from oncologists and surgeons and that they can convince FDA on that primary outcome. It makes a huge difference - if FDA accept LDC at 16 weeks the studies are achievable.
The overall survival at 18 month data will be very interesting, even if not statistically significant due to low numbers.
Really interesting and definitely worth the most recent capital raise.
(20min delay)