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 14 conditions that would qualify as an orphan designation. Many of these 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 condition and a rare form of headaches.
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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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