Given the breadth of the MCIT License and Research Agreements, I'll wager (actually I have by buying OXIS stock) that OXIS is one of the four drug development programs in reserve or 1 of the 11 still under consideration.
My $.02; It's the EMA and not the FDA.
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• Adaptive Licensing is a highly current topic. In March 2014, the EMA (European Medicines Agency) began to invite drug developers to apply for involvement in the pilot projects.
• Currently, two drug development programs have been accepted by the EMA as pilots. Three were rejected, four are in reserve and 11 are still under consideration.
• AL is part of a suite of global initiatives with shared features. These include: Staggered Approval, Progressive Authorisation, Conditional Licensing and, more recently, Medicines Adaptive Pathways (MAPs) or Medicines Adaptive Pathways to Patients (MAPPs).
• The high level of variance in AL approaches and scarcity of practical information justifies the need for an unbiased report of the strengths, weaknesses and opportunities for this system.
• If pilots are successful, AL may become more widely used across all regions, and also play an important role in shaping future regulatory policy, with the potential to affect all healthcare stakeholders.
• This new CBR report examines all existing information, and builds on that with conference attendance and new primary research with KOLs and figures central to the movement. It creates a balanced view, and provides an understanding of the current status and potential implications.
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