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Annovis Bio Inc (NYSE:ANVS) has completed a Type B meeting with the FDA regarding its planned Phase 3 studies of Buntanetap for the treatment of Parkinson's Disease (PD) as an offshoot of the Company's clinical program in Alzheimer's Disease (AD).
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- Following the Company's submission of Phase 2 data and the chronic toxicology data in animals, the Company requested directions to further develop Buntanetap in PD.
- The FDA guided initiating the Phase 3 clinical studies of Buntanetap for PD parallel with the AD program.
- Related: EXCLUSIVE: Annovis Bio's Parkinson's Candidate Improves Speed, Motor Function Vs. Placebo.
- The agency detailed guidance on the specific endpoints, entry criteria, and further study parameters for two Phase 3 studies to support a broad indication for early and late PD.
- Additionally, the FDA provided guidance on updating the existing Investigational New Drug Application (IND) for AD based on the successful Phase 2 study result and in preparation for an End of Phase 2 meeting on the AD indication.
- Price Action: ANVS shares are down 4.12% at $13.25 during the market session on the last check Tuesday.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.