Why This Biotech Stock Is Worth A Shot RGC laun
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RGC launched a follow-up research for their experimental liquid formula RGC-COV19TM in the treatment of COVID-19 symptoms on May 18, 2022. (EARTH-B Trial). The second study expanded on the encouraging findings from the initial EARTH experiment (EARTH-A Trial), which was carried out in 2020–2021. In the two studies, 95.5 percent of the participants (n=81) reported complete symptom relief six days after therapy, with the exception of occasional coughing and loss or reduction in sensation of taste and/or smell (sensory dysfunction).
RGC anticipates publishing data from its second clinical research of its standardised TCM formula for the treatment of ASD and ADHD in the coming months.
In order to set standards for therapy, dosing, adverse effects (AEs), and assessing patient response in a methodical and reproducible manner, Regencell Bioscience's initial clinical study was created. Seven adolescents with clinically confirmed ASD or ADHD, ranging in age from five to eleven, participated in the 2018–2019 study. Subjects got a personalised TCM formula for up to three months after stopping all current treatments and medications. Parental interviews and four validated assessment tools, such as the Autism Treatment Evaluation Checklist (ATEC), Gilliam Autism Rating Scale (GARS), Vanderbilt ADHD Diagnostic Parent Rating Scale (VADRS), and Pelham (SNAP)-IV 26-item Parent Rating Scale, were used to gauge the responses of the patients (SNAP-IV-26). During the course of treatment, all seven patients showed a reduction in symptoms on all four scales.
The second clinical trial assesses how three standardized TCM formula mixes (for mild, moderate, and severe impairment) respond to children in the same age group. Weekly practitioner meetings, twice daily medication for three to twelve months, and monthly assessments are all part of the study's design. The outcomes will be used to submit a proprietary Chinese medicine (pCm) registration application in Hong Kong, making the product available for purchase both over the counter and in other clinic.
To support its findings, Regencell is concentrating on its clinical research. Through these initiatives, the infrastructure for manufacturing and the supply chain that is needed to obtain pCm registration will be built. The commercialization of Regencell Bioscience's standardised formulations and pCm registration in Hong Kong are both subject to a four-year timeline. A lot of tasks lie ahead for the company:
•Finishing its second clinical trial and reviewing outcomes.
• Running more clinical studies to support the use of its patented formulas for ASD/ADHD and other uses.
• Getting IP protection in Hong Kong and other markets through the acquisition of patents and other types of IP.
• Setting up a manufacturing infrastructure and supply chain that complies with registration criteria.
• Compiling and filing paperwork for pCm approval.
• Develop the infrastructure and marketing and distribution plan.
We are encouraged by RGC's thoughtful, methodical approach to developing its therapies and communicating its progress to shareholders, which we believe may be a sign of greater things to come as it moves towards commercialization. RGC's steady share price ascent in recent weeks.
• Completing its second clinical trial 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.
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RGC’s steady share price ascension in recent weeks may be a sign of greater things to come as its moves towards commercialization, we are encouraged by its thoughtful, systematic approach to developing its therapies, and communicating its progress to shareholders.
https://finance.yahoo.com/news/rgc-ceo-figura...00965.html