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What will be the EU's decision on PBGENE-HBV further trials by end of 2025?
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Resolution / Starting Odds
Approved without conditions • 25%
Approved with conditions • 25%
Rejected • 25%
Pending decision • 25%
Announcements from the European Medicines Agency or Precision BioSciences
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Moldova Approves Precision BioSciences' PBGENE-HBV Gene Editing Study for Chronic Hepatitis B
Oct 24, 2024, 12:51 PM
Moldova has approved its first gene editing study for human trials targeting Hepatitis B virus (HBV). Precision BioSciences has received the necessary approval to initiate the PBGENE-HBV clinical trial, which aims to test the effectiveness of gene editing in removing persistent viral DNA in patients with chronic HBV. This marks a significant step in gene therapy, as it will be the first human trial using such technology to address this viral infection.
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Accelerated Approval • 25%
Full Approval • 25%
Conditional Approval • 25%
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Approved without conditions • 25%
Approved with conditions • 25%
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Hold Lifted • 33%
Hold Extended • 33%
New Restrictions • 34%
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Safety warning update • 25%
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