Innovation Pharmaceuticals Inc (IPIX)

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FDA Pathways:

Pathways specific to COVID-19
Coronavirus Treatment Acceleration Program
What it is: A “special emergency program” intended to accelerate the review of therapies intended to treat, cure or prevent COVID-19. The review program “uses every available method to move new treatments to patients as quickly as possible.” The pathway combines many elements from other review programs and pathways listed below, such as rolling review, accelerated timelines, hands-on support from FDA review staff and more.

The pathway is intended to begin early in clinical development, with the FDA providing “ultra-rapid, interactive input on most development plans,” review of clinical protocols within 24 hours of submission, review of single patient expanded access requests “generally within 3 hours” and working collaboratively to conduct quality assessments and transfer manufacturing “to avoid supply disruption.”

What it’s generally used for: The acceleration of medical therapies intended to treat, cure or prevent COVID-19.
Limitations: As with other review acceleration methods, the FDA’s ultra-rapid review will only be as useful as the ability of a company to move quickly to establish a manufacturing site, generate and analyze data, and make submissions. The ultra-rapid reviews may also miss some critical safety or efficacy issues that might have been discovered through more extensive analysis.
How it could be used in the context of COVID-19: Expect all COVID-19 products to receive an all-hands review by the FDA, with some product reviews taking place in days instead of months. The FDA says it plans to “continue to enhance and expand CTAP,” so further changes are expected soon.

Further reading: Coronavirus Treatment Acceleration Program
Also known as: CTAP
Regulatory/Legal authority: N/A. More akin to a pilot program, and not established under regulation or statute.