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Biotech / Medical : Geron Corp.
GERN 4.870-0.2%Jun 14 4:00 PM EDT

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From: Savant10/28/2021 10:02:11 AM
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  • Geron announced that imetelstat, the company's first in class telomerase inhibitor, has been granted an Innovation Passport, which is the first prescribed entry point to the Innovative Licensing and Access Pathway (ILAP) launched in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2021, post-Brexit.
  • Key benefits of being within ILAP include a 150-day accelerated assessment and rolling review of a Marketing Authorization Application as well as opportunities for frequent interactions with the review staff at the MHRA and its partner agencies to discuss imetelstat's development, regulatory plans, and reimbursement plans.
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