A core aspect of our business is developing therapies for rare and orphan diseases that affect millions of people.
The FDA defines an orphan disease as a condition that affects less than 200,000 Americans. Currently there are approximately 7,000 rare and orphan diseases affecting 25-30 million Americans. Less than 5% of these conditions have an approved therapy.
Dr. Shackelford has experience in treating patients with 20+ conditions that are considered rare. Many of these are orphan conditions have limited or no approved therapies at this moment. Shackelford Pharma has engaged a leading regulatory consultancy that specializes in FDA orphan and rare disease submissions. An evaluation of Shackelford’s orphan data is being analyzed in preparation for building a regulatory pathway that would lead to submissions to the FDA for Orphan designations as quickly as possible.
Shackelford’s near term orphan drug development will focus on childhood epileptic conditions.
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Shackelford Pharma’s Regulation A Financing is now open. Investors are required to fill out the form below to begin the investment process.
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