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Then why are you still here?
Seems odd to me that someone would spend so much time on a board dedicated to "this crap".
New patent grant: https://patents.justia.com/patent/11099174
Too bad the diagnostics company is private. Would be nice to know how far they have come by now. Maybe the test is already available for commercial use?
I don't follow them so I wouldn't know anything about the details. What I do know is that stock prices for early stage biotechs tend to rely pretty heavily on reputation and investor sentiment. Data is limited so investors have to work with what little they're given.
Same thing here. SNPX isn't going anywhere until they prove their critics wrong. Great opportunity for long-term bulls though.
What do you mean by FDA trial? I'm pretty sure all these clinical trials are performed by the biotech companies in collaboration with contract research organizations.
If a company lies about its collaboration with a third party then there's a reason to assume they might be lying about something else, which justifies a stock price drop.
The FDA looks at data and assists companies with grant money, but I don't remember them being directly involved in any trials.
I could be wrong of course, but that's how I remember it.
Great value if you believe in the science. Time will tell if they're right or wrong.
Yes, eventually. Not for this trial though.
Doesn't seem to include any updates about current trial progress, although it should be easier to predict the timeline once they release a PR about completing enrollment.
Last patient follow-up is at week 42, so my guess is we'll see the results about 46-50 weeks after the PR.
Some quotes from the latest 10-Q:
- "As of August 10, 2021, there were 6,136,302 shares of the registrant’s common stock, $0.0001 par value per share, issued and outstanding."
- "We expect that our current cash and cash equivalents of approximately $32.1 million will be sufficient to support our projected operating requirements for at least the next 12 months from the Form 10-Q filing date, which would include the continuing development and current Phase 2 clinical trial, of bryostatin, our novel drug targeting the activation of PKC epsilon."
- "Of the total $2.7 million available from the NIH grant, approximately $1 million was received for trial-related expenses incurred since grant inception to June 2021 with the remaining $1.7 million available for reimbursement during the period April 2021 to March 2022. During July and thru August 10, 2021, the Company received approximately $500,000 of the remaining $1.7 million NIH grant."
- "On August 5, 2021, the Company announced its memorandum of understanding with Nemours to initiate a clinical trial using bryostatin, under Orphan Drug Status, to treat Fragile X. The Company intends to provide the bryostatin drug product and obtain the investigational new drug documentation (“IND”) and Nemours intends to provide the clinical site and attendant support for the trial. The Company and Nemours, jointly, will develop the trial protocol. The Company estimates its total trial and IND cost to be approximately $700,000."
Correct. My guess is that they don't have the resources to go after other indications at this moment, even if they want to.
Revolutionary maybe, but certainly not a miracle. The target enzyme is already present in the brain, and I feel like growing new connections isn't the best fix compared to going after what's causing these disorders in the first place.
The most severe AD patients have been excluded from this trial because it apparently didn't work on them. I assume it's because they have lost too many neurons for them to be able to create new connections with each other.
Building a new bridge between two cities is useless if both cities have blown up.
AD, autism and FXS are all brain disorders caused by faulty wiring in the brain (it's actually a bit more complicated than that but you get the point). The idea is to regenerate the wiring in the brain by activating an enzyme called PKCe, which seems to be important for brain development in normal children but disappears as time goes on due to age-related damage. Bryo is their first generation PKCe activator and if they are successful they will continue development on their drug platform of next-gen PKCe activators.
Will it work? Nobody knows, but there are preclinical mouse studies showing improvements in both FXS mice and autistic mice.
It's all some form of brain damage really, and the hope is that PKCe activators are the first class of drugs to make the human brain create new connections to make up for the damaged or missing ones.
Is it a miracle drug? Of course not, but it could be the first drug that generates new synapses and creates new connections in the brain. Is that the right approach? Again, nobody knows.
Our memories and personalities are all formed by those brain cells in our head that are intervowen with each other, so it's very important that we maintain existing connections and repair damaged ones. It is after all the most important organ we have.
A beating heart won't help much if your head is gone.
Probably a dose-finding P2a. The safety profile for bryo is excellent, so I doubt they need to run more P1 trials.
Could be this test that they got a breakthrough designation for a while back:
https://discerntest.com/
https://www.prnewswire.com/news-releases/neurodiagnostics-llc-new-alzheimers-assay-granted-breakthrough-device-designation-by-us-food-and-drug-administration-300731304.html
Not really newsworthy since the trial has been planned for years and an MoU isn't legally binding.
At least they're making progress towards actually launching the trial though.
I think the idea is that AD will bring in the most revenue which they can then use to fund trials for other stuff.
Clinical trials take time and money, so getting approved for AD first will get everyone the most bang for the buck.
There is a limited amount of the natural version left and the synthetic one hasn't completed a bioequivalence trial yet.
On top of that, they need to pay for the drug since it is produced by a third party.
Right now they have enough cash for the current AD trial and maybe one more indication if we're lucky.
It's important to remember that the research in this area is slow due to a lack of resources and that this drug platform is still completely untested for several indications.
There just isn't enough manpower and resources available to go beyond the current AD trial.
It's probably not even an actual improvement. If a patient answers the same questionnaire one month apart, they will almost definitely score a point or two higher just by remembering some of the questions.
That's why statistical power and significance is so important. Alzheimer's is a very slow disease and it takes time for patients to deteriorate.
Ouch. -55% pre-market. Looks like they made the same mistake of making their trial too short.
It takes time for AD patients to decline, and that needs to be accounted for when designing trials.
That "interesting" trial design sure sounds like data manipulation to me.
If patients improve by taking sugar water you either have a bad trial design or you're dealing with a disease that can be cured with sugar water.
Because Alzheimer's is a real disease with no cure, there's only one explanation for why placebo patients performed well and it's because the trial was too short and the scale used for measuring patients is flawed.
Almost all AD companies measure patients by having them answer questionnaires rather than measure meaningful biomarkers, for the simple reason that we currently don't know of any better way to measure the decline.
They tried with amyloid and that clearly didn't work.
Like you mentioned, 30 day washout period worked perfectly fine in the last trial and they still extended it to 90 days this time around just to be safe.
They also doubled the dosing period and extended the monitoring period in order to allow placebo patients to decline further and increase the difference between groups.
Last CC showed that the average improvement in the target group is about +4 points on the SIB scale after 13 weeks of dosing when combining the patients of both trials.
If I remember correctly, they got a Harvard professor of biostatistics to help them with the current trial design in order to maximize statistical power and remove any doubts about the upcoming results.
You make it sound like it's coordinated. The price constantly rises and drops by 10%, and today is no different.
I'm still convinced this will keep swinging between $6-12 until results with the occasional spike.
Was amusing to hear several callers ask about why the stock price is so disconnected from company events and then have that one guy offer his possible explanation.
My take on it is that there's enough money to complete the current trial but their ambitions are clearly much higher than what their cash supply allows.
Great opportunity to buy more shares for the long-term bulls. Other than that, I don't see what else one can do but wait until next year.
They did miss all their primary endpoints. All this talk about positive results is based on a post-hoc analysis.
First trial failure is blamed on Namenda and second one on baseline imbalance. That's why they're currently running a third one that excludes those factors.
True, there's just something unique about their MOA that keeps pulling me back in, even if the stock price has been falling for years now.
Guess we'll know for sure in the coming months whether the price is moving to a new baseline or if it's just another temporary spike.
Hopefully they'll publish a new paper this year. Posters are usually really short and only include one or two charts.
Would be pretty funny if a new company name and a 1:20 reverse split is all it takes to change people's minds about a company.
Either way, this is fundamentally still the same company as before, only now it's more well-funded with a new CEO, all paid by printing tons of new shares and warrants.
Hopefully they won't dilute more now that they have more than enough cash to finish the trial.
Yes, the company was known as Neurotrope and had been listed on Nasdaq since 2017 before the merger and spinoff in late 2020.
I will be very surprised if people don't realize this is the same company with a different name.
It was listed on Nasdaq a year ago too but I don't remember retail being this optimistic about it back then.
Maybe it really just is the Biogen decision that changed people's minds.
I think it's pretty obvious that new results will dramatically change the price, but we're not getting those for another year.
Hopefully you're right about the warrants. The sooner they are exercised the better. Next quarterly report should give us a better understanding of their current financial situation.
I don't get where the recent retail hype is coming from. The data is still the same now as it was last year.
Probably just more details about the last trial. Maybe highlighting the fact that patients beat placebo in the last trial when adjusting for baseline imbalance.
We've known that since last year though, so it's really just them giving investors a more detailed look at the data.
I'd say it's neutral. Conference calls like this don't do much for the stock price but are sometimes useful for learning new things about the results.
Poster could be interesting though. Let's see what next week brings us.
It's nice to see clinics refusing to treat patients with this $50,000 travesty.
At least some people are recognizing how rotten the FDA has become under Janet Woodcock. Taxpayers do not deserve to have their hard-earned cash wasted like this.
"Synaptogenix Announces Conference Call to Discuss AAIC Abstract Findings"
https://www.prnewswire.com/news-releases/synaptogenix-announces-conference-call-to-discuss-aaic-abstract-findings-301338270.html
Not sure how to feel about this. They deserve to paid for their work but have once again found a new reason to reduce existing shareholder value by increasing their yearly grant more than 10x in dollar amounts, not to mention constantly doling out warrants to financial advisors that take a 10% fee from each fundraiser. I don't know if it's the chairman or the CFO that is responsible for this behavior, but it's nevertheless rubbing me the wrong way.
No wonder their market cap is lower than the competition.
Sounds very promising, but also a bit cherry-picked. Hopefully the current trial will produce results that don't need a post-hoc analysis to prove their point.
Looking forward to reading the paper they will publish about this.
"Synaptogenix to Present Data at Alzheimer's Association International Conference 2021 Highlighting Bryostatin Restores Cognitive Function Above Baseline"
https://www.prnewswire.com/news-releases/synaptogenix-to-present-data-at-alzheimers-association-international-conference-2021-highlighting-bryostatin-restores-cognitive-function-above-baseline-301333425.html
I hear the side effects can get pretty severe compared to the minimal benefit that patients get.
Quite embarrassing for the FDA and its administrator that played a role in worsening the opioid crisis.