Innovative Australian Drug receives Break-through Therapy “Barrier to Innovation” Waiver by the FDA CVM (USA Federal Drug Agency).
The FDA CVM is the FDA’s veterinarian department.
The assessment criteria are
- Innovation: a drug must be highly innovative, novel, a medical break-through.
- Efficacy: Is there sufficient information for proof of concept in a validated in vitro system or in the target animal or an animal model of the target animal (e.g., laboratory rodent species)?
- Small-Medium Company: Is the company below $20 million in market size.
We were able to satisfy the criteria and examiners with a detailed application outlining the scientific evidence, they do not give these out lightly.
This success adds serious credibility to our dealings with the government, regulators and the market.
I would like to thank our USA FDA CVM Consultants Schafer and Associates for all their assistance and guidance to date.
a/Prof Anthony Sasse,
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