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FDA Regulatory

NeOnc’s drug delivery technology has already been granted Fast-Track and Orphan Drug status by the Food and Drug Administration (FDA), supporting its potential to benefit an underserved patient base.

Regulatory and Certification

NeOnc has successfully applied for and received both Orphan Drug (O.D.) and Fast-Track status of our NEO100 and NEO212 formulations as they move from the developmental proof-of-concept stage into validation study readiness. The NEO100 formulation was approved for its indices treating high-grade glioma and its ability to impact insulin-resistant gliomas. Our NEO212 was further approved for both high-grade gliomas and breast cancer metastasizing to the brain.

Orphan Drug Status Purpose

O.D.D. status is given to a drug manufacturer who can show that their formulation:

  1. Shows promise in treating, preventing, or diagnosing an orphan disease.
  2. The orphan disease affects a patient population not greater than 200,000 people.
  3. The drug has the potential to provide at least equal benefit to currently approved drugs being used for that disease without adding any greater side-effect burden.

When granted, an O.D.D. manufacturer can immediately enter human clinical trials through an approved Institutional Review Board (IRB) to gather efficacy data on the drug. In addition, they are granted a seven-year window of exclusive marketing rights, fee reductions, and additional tax incentives. The O.D.D. manufacturer is also given access to any FDA information from Patient-Focused Drug Development (PFDD) meetings which can assist the manufacturer in its O.D.D. development. Finally, the manufacturer can show through its validation work that the Orphan Drug is providing benefits in at least one of the following categories:

  • Showing superior effectiveness, effect on serious outcomes, or improved effect on serious outcomes
  • Avoiding serious side effects of an available therapy.
  • Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome.
  • Decreasing the clinically significant toxicity of an available therapy that is common and causes discontinuation of treatment.
  • Ability to address emerging or anticipated public health needs.

Then the FDA can also grant the Orphan Drug manufacturer Fast-Tract status which provides the following additional benefits that help dramatically cut the average amount of time and money needed for a traditional drug approval process.

  • More frequent meetings with the FDA to discuss the drug’s development plan and ensure the appropriate data is collected to support drug approval.
  • More frequent written communication from the FDA about such things as the design of the proposed clinical trials and the use of biomarkers.
  • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.
  • Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by the FDA rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.