Status (Risk De-Layered):
All major data submitted. NEPA risk reduced from High to Low. USDA confirmed we are at the front of the line for review once shutdown backlog clears. Strategy led by Dr. Paul Hauer, former Director of USDA CVB.
All major data packages submitted to USDA
Environmental risk reduced from High to Low
Front of line post-shutdown backlog
Expected 90-120 days after final review
We deliberately over-delivered on our USDA submission. The Valley Fever vaccine dossier includes:
Species Studies: Mouse, rabbit, cat, and dog
Routes: Subcutaneous and intramuscular
Formulations: Liquid and lyophilized
Stability: Room temp, refrigerated, frozen
Safety: Environmental studies & protocols (NEPA risk low)
Genetics: Full sequencing of seed stock
This is one of the most comprehensive veterinary vaccine data packages submitted to USDA in recent memory.
To reduce regulatory risk to the lowest possible level, we built a leadership bench unusual for a company of our size:
Dr. Paul Hauer
Former Director of USDA Center for Veterinary Biologics (CVB). Leads our vaccine regulatory strategy and NEPA positioning. He literally wrote the playbook we're following.
Kevin McCarthy
Former Speaker of the U.S. House and Anivive board member. Coordinated cross-agency support spanning USDA, FDA, CDC, and NIH. Helped embed fungal vaccine language in legislation.
Federal Alignment
FDA issued fungal vaccine guidance. NIH's March 2025 Strategic Plan explicitly endorses our approach. Fungal vaccines now viewed as a national priority.
USDA Confirmation:
Once the shutdown backlog clears, we are at the front of the queue for our final review meeting (scheduled), which historically is followed by licensure 90–120 days later.
We continue to work on three paths with USDA, each using the same core dataset:
1. Full Approval for Dogs
Complete licensure for nationwide distribution
2. Conditional Approval in Endemic Areas
Arizona and other highly endemic regions
3. Zoo Authorization
Susceptible species in endemic regions
Bottom Line:
We've moved from "Can this be approved?" to "How do we navigate the final steps most efficiently?" The remaining work is execution, not reinvention.
Before licensure, we've already lined up more than $50M in non-binding vaccine commitments (subject to regulatory approval):
NIH biodefense contract classified as "Essential Service"
Pre-orders from 600+ hospitals, including ~450,000 doses for Arizona alone