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Originally posted by Garris1234:
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No, a change in the German government has not stopped the OncoSil trial.Background on OncoSil and Its TrialsOncoSil Medical Limited is a company focused on developing innovative treatments for pancreatic cancer, particularly through its OncoSil™ device, which involves endoscopic injection of radioactive microparticles into tumors. The device has received various approvals and designations, including CE marking in Europe and Breakthrough Device designation in the US.Recent DevelopmentsAs of March 2025, significant developments have occurred regarding the OncoSil trial in Germany. The German Federal Joint Committee (G-BA) approved a directive for testing the new treatment method involving the OncoSil device. This approval allows for a randomized controlled trial under a Coverage with Evidence Development (CED) program, which means that while additional evidence is gathered to support its effectiveness, the treatment can be conditionally reimbursed.Impact of Government ChangesThe recent changes in the German government have introduced a National Pharma Strategy aimed at revitalizing the pharmaceutical industry and enhancing clinical research within Germany. This strategy includes measures to simplify trial processes and improve market access for new treatments. Notably, it emphasizes faster approvals and reduced bureaucracy for clinical trials.Despite these governmental changes, there has been no indication that they have negatively impacted or halted the OncoSil trial. In fact, these reforms may enhance the environment for conducting clinical trials by making it easier for companies like OncoSil to operate within Germany.ConclusionIn summary, a change in the German government has not stopped the OncoSil trial; rather, ongoing governmental reforms are likely to support such initiatives by improving conditions for clinical research and development in Germany.
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if you want clarification, email Nigel. I’m sure he’ll be happy to clarify any concerns
(20min delay)