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Tuesday, November 02, 2021 3:08:46 PM
Sava is running 2 larger trials (less severe is likely to require more patients, most often due to misdiagnosis and slower decline). One will be complete in October 2023. The other almost a year afterwards. My guess is that if the first trial completes and hits on already approved FDA endpoints, then they would be provisionally approved and marketing the drug in 2024 while the second trial continues to gather data on both efficacy and safety. That's a guess and FDA may want both complete.
Not so clear a path with SNPX. Our P2b controlled data will read out in around a year. CEO has stated that although its not impossible, it would be unlikely the current trial would gain approval even with other previous studies. He wanted to be conservative in that measure. Now we have the new "wildcard" dosing trial to commence next year that we have no details on yet as well as additional CNS trials. At some point if we continue to improve cognition in these trials, we would likely get approval but we don't really know when. If we are required to run an additional, larger trial after results next year it likely would kick off first half of 2022 and run most of 2023, potentially reading out around the same time as SAVA's first of 2 current trials. Once again this is assuming a smaller trial (maybe 400-500 patients) and a shorter duration (6 months) for us than SAVA is currently being asked to run due to a more severe AD population.
All said, its hard to argue SAVA isn't ahead of us, but there certainly is an argument. Much better argument is that bryostatin is the superior drug IMO. Entire post is JMHO
Recent SNPX News
- Synaptogenix Announces FDA Authorization of IND Application for Clinical Trial for Bryostatin-1 in Multiple Sclerosis • PR Newswire (US) • 06/26/2024 01:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 09:03:21 PM
- Synaptogenix Applauds DEA Proposal to Reclassify Cannabis and Shares Expected Benefits to Cannasoul for Cannabinoid-Based Drug Discovery • PR Newswire (US) • 05/07/2024 01:00:00 PM
- Synaptogenix Regains Compliance with Nasdaq Minimum Bid Price Requirement for Continued Listing • PR Newswire (US) • 04/24/2024 01:15:00 PM
- Synaptogenix Increases Stake in Innovative Psilocybin Drug Discovery Company through its Partnership with Cannasoul Analytics • PR Newswire (US) • 04/09/2024 01:15:00 PM
- Synaptogenix Announces Reverse Stock Split to Maintain Nasdaq Listing • PR Newswire (US) • 04/03/2024 12:00:00 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/06/2024 03:16:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/21/2023 10:00:18 PM
- Synaptogenix President Daniel L. Alkon, M.D. Honored for Scientific Presentation at USC-Sponsored Forum on Age-Related Diseases and Neurodegenerative Disorders • PR Newswire (US) • 12/19/2023 02:00:00 PM
- Synaptogenix Joins Leading Neuroscientists and Academics as Speaker at USC-Sponsored Forum on Age-Related Diseases including Alzheimer's • PR Newswire (US) • 12/06/2023 02:00:00 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 11/14/2023 10:05:18 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 11/13/2023 10:00:48 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/06/2023 10:00:23 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 11/03/2023 09:00:19 PM
- Synaptogenix Acquires Significant Stake in Cannasoul Analtyics Ltd. Co-founded by The Technion - Israel Institute of Technology • PR Newswire (US) • 11/02/2023 01:00:00 PM
- Synaptogenix Announces Peer-Reviewed Publication of NIH-Sponsored Phase 2 Clinical Trial Results Demonstrating Safe, Significant, and Persistent Benefits of Bryostatin-1 in Advanced Alzheimer's Disease • PR Newswire (US) • 09/26/2023 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/22/2023 08:05:55 PM
- Bryostatin-1 from Synaptogenix Shows Statistically Significant Results as an ALS Treatment in Pre-Clinical Independent Study • PR Newswire (US) • 09/07/2023 01:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2023 09:00:40 PM
- Synaptogenix and Cleveland Clinic to Submit Investigational New Drug (IND) Application to FDA for Clinical Trial of Bryostatin-1 in Multiple Sclerosis • PR Newswire (US) • 07/19/2023 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/19/2023 12:55:57 PM
- Synaptogenix Abstract Highlighting Bryostatin-1 Benefits in Severe Alzheimer's Disease Accepted for Presentation at 11th International Brain Research Organization World Congress of Neuroscience • PR Newswire (US) • 07/13/2023 01:00:00 PM
Glidelogic Corp. Becomes TikTok Shop Partner, Opening a New Chapter in E-commerce Services • GDLG • Jul 5, 2024 7:09 AM
Freedom Holdings Corporate Update; Announces Management Has Signed Letter of Intent • FHLD • Jul 3, 2024 9:00 AM
EWRC's 21 Moves Gaming Studios Moves to SONY Pictures Studios and Green Lights Development of a Third Upcoming Game • EWRC • Jul 2, 2024 8:00 AM
BNCM and DELEX Healthcare Group Announce Strategic Merger to Drive Expansion and Growth • BNCM • Jul 2, 2024 7:19 AM
NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM
Mass Megawatts Announces $220,500 Debt Cancellation Agreement to Improve Financing and Sales of a New Product to be Announced on July 11 • MMMW • Jun 28, 2024 7:30 AM