Regencell Bioscience Holdings Ltd RGC

$RGC Path to Registration and Commercialization

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Regencell Bioscience's Path to Registration and Commercialization

Regencell Bioscience has a four-year timeframe to commercialize its standardized formulations and gain proprietary Chinese medicine (pCm) registration in Hong Kong. The Company has a number of tasks ahead:

• Completing its second clinical trial for ASD/ADHD and COVID, and evaluating results.

• Conducting additional clinical trials to support its proprietary formulae in ASD/ADHD and other applications.

• Obtaining patents and other forms of IP protection in Hong Kong and other markets.

• Establishing manufacturing capability and supply chain that will meet registration requirements.

• Assembling and filing documentation for pCm approval.

• Build out its marketing and distribution strategy and infrastructure.

We believe that an emphasis on conducting well-designed clinical trials that measure outcomes based on well-established assessment instruments, will provide Regencell Bioscience with a competitive advantage in terms of expertise and credibility in an industry that is moving towards higher standards for efficacy, safety and quality. While there is still much work to do, in our view, Regencell Bioscience is taking a thoughtful, systematic approach to developing its TCM formulae.

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