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The 505(b)(2) FDA Approval Process

The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways. The pathway was created by a 1984 amendment, with 505(b)(2) referring to a section of the Act. The provisions of 505(b)(2) were created, at least in part, to help avoid unnecessary duplication of studies already performed on a previously approved medication. A similar pathway is available in Europe via Article 10 of Directive 2001/83/EC.
Examples of NDAs that may be suitable for the 505(b)(2) route include a new dosage form that acts more rapidly, where two active ingredients are combined in a novel way, where a route of administration or mechanism of drug delivery is developed that is preferable for patients, and a new indication for a previously approved drug. The 505(b)(2) is an expedited approach to FDA approval that has multiple advantages. A key feature of 505(b)(2) is that the FDA can rely on prior study data including publically available data and data not developed by the NDA applicant. Other advantages include achieving FDA buy in for the developmental plan before it is commenced, a considerably shorter timeline for approval (around 18-36 months vs. the 9.5 years for conventional drug development), the potential to run pre-clinical and clinical studies in parallel,a significantly higher likelihood of approval (only between 9.6% and 11.9% of medications developed through the conventional approach achieve FDA approval), and a much reduced cost. The 505(b)(2) pathway may also lead to eligibility for a period of market exclusivity such as with an orphan drug, a new chemical entity, or in pediatrics.This accelerated path to approval and the prospect of a period of exclusivity make the 505(b)(2) a cost-effective and commercially attractive route when the conditions are right.

SCPs and the 505(b)(2) Process

We are pursuing the 505(b)(2) pathway for our SCP products as we have taken existing approved moieties, and through our patented conjugation process have improved their efficacy, reduced the adverse outcome rate, and significantly improved their solubility making them suitable for a variety of alternate delivery routes including oral and topical. We have existing pre-clinical and clinical data that can be considered as part of the approval process, and the target population of patients for our SCPs have poor prognosis cancers and they are urgently in need of alternative and efficacious therapies.We believe that our SCP medications will afford us seven years of market exclusivity. The cost per moiety on average to fully navigate the 505(b)(2) process will be approximately $5 Million USD, and the length of the process will be about 18-36 months.