Table 5.

Summary of current and possible alternative pathways as applied to whole phage and phage derived therapeutics.

	“Classical” licensing	Adaptive licensing	Compassionate use
Advantages	• “Gold” Standard • Already established for antibacterial drugs • Would be suitable for phage derived products • Additional legislation being introduced to streamline procedures for antibacterial drugs	• Limited population approvals • Iterative process which can inform future work • Can be adapted for pre and custom phage cocktails	• Immediate clinical usage • Data could be used to inform future work • Could be utilized for all forms of phage therapy
Disadvantages	• Recruitment for trials • Cost • Reformulation would require additional trials	• Varying degrees of complexity • Limited population approvals	• Limited to a single patient basis • Not actually approved for use
Other considerations	• Likely that only highly defined products would be able to succeed, limiting success	• Approval of predefined libraries would require wholly new approvals process	• Lack of public awareness of phages
Time to implementa	++	++ or +++*	+
Cost to implementa	$$$	$$ or $$$*	$

^aAssumption has been made that “Classical” licensing is a baseline.

^*Both cost and time to implementation would be affected by the form of treatment chosen. Pre-approved libraries taking longer and costing more to achieve.