AGT103-T FDA Approval Timeline

#agt103t #genetherapy #agtclinicaltrial #hivcure #hivvaccine

AGT103-T FDA Approval Timeline: What to Expect?

Are we closer than ever to a functional cure for HIV? In this video, we explore AGT103-T, a revolutionary gene therapy developed by Addimmune that's making waves in HIV research. From its early clinical trials to the projected FDA approval timeline, we break down each milestone, what it means, and what you can expect in the coming years.

You'll learn:

✅ What AGT103-T is and how it works?
✅ Key milestones in the FDA clinical trial process
✅ Insights from Phase 1a trials
✅ What’s next in 2025 and beyond?
✅ What AGT103-T means for people living with HIV?
✅ When we could realistically expect full FDA approval of AGT103-T?

If you're someone searching for reliable HIV testing, updates on HIV treatment breakthroughs, or simply curious about where science is headed next, this video is for you.

🔬 Understanding the FDA Approval Process

Preclinical Studies: Initial laboratory and animal studies to assess the therapy's safety and biological activity.​

Investigational New Drug (IND) Application: Submission to the FDA to begin clinical trials in humans.​

Phase 1 Trials: Focus on safety, determining safe dosage ranges, and identifying side effects.​

Phase 2 Trials: Assess efficacy and further evaluate safety in a larger group of participants.​

Phase 3 Trials: Confirm effectiveness, monitor side effects, and compare with standard treatments in large populations.​

New Drug Application (NDA): Comprehensive submission to the FDA for approval to market the therapy.​

FDA Review and Approval: The FDA reviews the NDA, and if the benefits outweigh the risks, approval is granted.​

⏳ Projected Timeline for FDA Approval

Phase 1b Trial Initiation: Expected to commence in 2024, focusing on refining dosing and further evaluating safety and efficacy. ​

Phase 2 Trials: Anticipated to begin following successful Phase 1b outcomes, potentially in 2025.​

Phase 3 Trials: Could commence in 2026, contingent upon positive results from earlier phases.​

FDA Approval: If all trial phases demonstrate favorable results, FDA approval might be achievable soon.
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🔔 Make sure to watch till the end to learn about the latest research, and don’t forget to subscribe for more updates on HIV treatment and prevention!

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⏱️ Timestamps:
00:00 – Could This Be the Future of HIV Treatment?
01:05 – What Is AGT103-T?
02:35 – Why This Gene Therapy Matters
04:00 – The FDA Approval Process Explained
05:42 – Timeline Breakdown: Phase 1 to Present
07:30 – Phase 1a Trial Highlights
09:05 – What to Expect in Phase 1b (2024)
10:15 – Could AGT103-T Really Work Without Daily Meds?
11:40 – What Does FDA Approval Really Mean?
13:10 – Potential Impact on HIV Treatment in the U.S.
14:40 – How to Stay Updated on Clinical Trials
16:00 – Final Thoughts & What You Can Do Today

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⚠️ Disclaimer:
This video is for educational and informational purposes only. It does not provide medical advice, diagnosis, or treatment. Please consult a healthcare professional before making any decisions related to your health or HIV treatment options.

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