Curated News
By: NewsRamp Editorial Staff
March 28, 2024
Medicus Pharma Receives FDA Feedback on Phase 2 Clinical Protocol of SKNJCT-003
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Discuss on SubstackTLDR
- Medicus Pharma's favorable study results position them for potential regulatory approval, giving them a competitive advantage in the pharmaceutical market.
- The FDA has requested additional data from clinical studies, specifically focusing on doses and adverse events, to support Medicus Pharma's regulatory submissions.
- Medicus Pharma's commitment to advancing innovative therapies with a strong focus on safety and efficacy demonstrates their dedication to bringing impactful treatments to patients in need.
- The investigational product, D-MNA, demonstrated favorable safety profiles across all dose levels among the thirteen participants enrolled in the study, showing promising potential for patient treatment.
Impact - Why it Matters
The FDA's feedback on Medicus Pharma's study findings could impact the development of a potential therapeutic option. This news highlights the company's commitment to meeting regulatory guidelines and advancing innovative therapies, ultimately aiming to bring impactful treatments to patients in need.
Summary
Dr. Raza Bokhari, Executive Chairman and CEO of Medicus Pharma, shares significant updates on the company's interaction with the FDA. The FDA has provided feedback on the recent study findings, requesting additional data to support the doses of micro-array needles containing doxorubicin. Medicus Pharma is committed to making a comprehensive submission in the second quarter of 2024, including the requested data and an updated investigator brochure.
Source Statement
This curated news summary relied on this press release disributed by News Direct. Read the source press release here, Medicus Pharma Receives FDA Feedback on Phase 2 Clinical Protocol of SKNJCT-003
