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FDA Team Advises Innovative Drug Company in Phase II

Key Facts

  • The company is developing a new drug for neurodegenerative diseases
  • The company has limited data and needs to develop more supportive data
  • Our team provides strategic advice on clinical development and FDA pathways to approval

The Situation

We represent a company focused on developing new drug therapies for the treatment of neurodegenerative diseases and developmental disorders. 

The Approach

Mintz provided a broad range of regulatory advice to the company. Our work included developing a Compassionate Use Program and responding to individual compassionate use requests, drafting press release information regarding results of the company's Phase II clinical study, and strategic planning for additional dosing and clinical evaluation programs and potential FDA accelerated pathways based on the results of the Phase II study. This work required a full assessment of the topline and complete study reports and coordination of post hoc data analysis to draw out key data points for further assessment.

The Outcome

We are currently preparing a strategy to take to the FDA in hopes that the agency will recognize the opportunity presented by this drug in development, and grant the company the benefits of an accelerated pathway for development and review. We are actively involved in the clinical development committee, presentations to the company's board, and activities around publication and presentation of the data.

Supporting Professionals