Processa Pharmaceuticals (NASDAQ: PCSA), a clinical-stage biopharmaceutical company developing drugs to improve the survival and/or quality of life for patients who have unmet medical conditions, has announced that its CEO Dr. David Young will present at the World Orphan Drug Congress USA 2022 Conference. Dr. Young’s presentation, “Thinking Regulatory First – Considerations for the Effective Development of Rare Disease Therapies,” is scheduled to start at 3:25 p.m. ET on Wednesday, July 13, 2022. “The Processa team has successfully developed a number of drugs over the last 30 years with over 30 FDA approvals, some in orphan indications,” said Dr. Young. “For example, while at Questcor, this team was able to successfully obtain the FDA approval for an Acthar supplemental New Drug Application for the treatment of infantile spasms, an ultra-rare orphan condition. Through our collaboration with the FDA, we were able to define the clinical studies and regulatory path required to demonstrate that the benefits of Acthar for the treatment of infantile spasms outweighed the risks associated with Acthar treatment, the risks of using Acthar off-label with various regimens, and the risks associated with the natural progression of infantile spasms without Acthar treatment.”
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About Processa Pharmaceuticals Inc.
The mission of Processa is to develop products with existing clinical evidence of efficacy for patients with unmet or underserved medical conditions who need treatment options that improve survival and/or quality of life. The company uses these criteria for selection to further develop its pipeline programs to achieve high-value milestones effectively and efficiently. Active clinical pipeline programs include: PCS6422 (metastatic colorectal cancer and breast cancer), PCS499 (ulcerative necrobiosis lipoidica) and PCS12852 (GI motility/gastroparesis). The members of the Processa development team have been involved with more than 30 drug approvals by the FDA (including drug products targeted to orphan disease conditions) and more than 100 FDA meetings throughout their careers. For more information, visit the company’s website at www.ProcessaPharma.com.
NOTE TO INVESTORS: The latest news and updates relating to PCSA are available in the company’s newsroom at https://ibn.fm/PCSA
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