Snoretox Awarded “Barrier to Innovation” Waiver by the FDA CVM (USA Federal Drug Agency).

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,

What others are saying

Board Appointments Announced

Australian headquartered and globally focussed emerging biotech, Snoretox Pty Ltd is pleased to announce the establishment of its inaugural Board of Directors. Snoretox is developing tetanus toxin antibodies intended to address improvement in conditions affected by lax muscle tone and neuromuscular control.

Dr Tony Sasse, Founder of Snoretox said that the discovery program, undertaken by the Company in partnership with RMIT University, was ready to pivot to development and upscaling with a view to entering the clinic. Status of the intellectual property portfolio and early stage investment discussions are very positive. Snoretox will seek to undertake as much as possible of the critical path with Australian researchers, clinicians and development partners to advantage the Australian community.

I am very pleased with the foundation of the Board and am confident that the inaugural Board of Directors, partners and colleagues offer complementary skills that will facilitate the further development and commercialisation of the Company’s assets Dr Sasse said.

The inaugural Board members are:

Dr Tony Sasse

Tony Sasse is the Founder of Snoretox Pty Ltd and is a consulting Pulmonologist in rural Australia who saw first the power of the tetanus toxin molecule whilst working in a remote hospital in India, where he treated many cases of Tetanus. He is also an Adjunct Associate Professor at RMIT University

Professor Peter Smooker

Peter Smooker is a very experienced biotechnologist, and for the past 20 years has headed a Biotechnology laboratory at RMIT University. His main area of study is the structure and function of useful proteins, and as such directed the development of the exciting muscle-toning drugs in a long-standing collaboration with Snoretox.

Mr John Mitchell

John Mitchell has a diverse business/governance background in local government and community governance. He has extensive experience in dealing with large industries, small/medium enterprises, community groups, environmental and education organisations and regulatory authorities.

Dr Dennis Feeney

Dennis Feeney is the Founder of Venture Technology Group and is experienced in drug development and commercialisation in the settings of global pharma and biotech.

 

Further details about the Company and Board may be found here https://snoretox.com/