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It's a continuation application for an older patent as mentioned in the description. That's why new applications and grants keep appearing with the same name as older ones.
Apparently they're used to expand the scope of existing patents in order to increase the strength of a patent portfolio.
In this case the original application was filed in 2008, which means it'll expire in 2033 if they can get a 5 year extension on top of the regular 20 years.
What do you mean? I'm not sure I understand the question.
Yes. Lots of interesting things happening next year.
Probably in February, since that is 42 weeks after they announced complete enrollment on April 19th.
42 weeks.
"Week 42 is the final follow-up for study subjects, occurring 16 weeks after the last dose of study drug."
https://clinicaltrials.gov/ct2/show/NCT04538066
Could be, but the 4 month extension doesn't include any additional doses, so they could still announce dosing conclusion now even if data collection is still ongoing.
Or maybe they choose not to. Who knows?
Everyone wishes they could've waited for the lowest lows before buying, but that's not how real life works. Better to be early than to miss the train entirely.
And if the trial fails it won't matter much whether you bought at $6 or $4.
I don't claim ownership of the 5s lol. That's just one of many places the price can go. I don't like to blame it on the company when we've seen this thing move 10% multiple times in recent days. Back in 2017 it used to move 15% up and down on no news.
Like I said in an earlier post, it depends on the market we're in.
Not sure if it's been discussed before, but this article was referenced in the latest presentation:
https://www.ipwatchdog.com/2021/10/26/assessing-much-alzheimers-drug-worth/
Could be useful for those trying to value this company more accurately.
Doesn't seem like it. Maybe they'll announce dosing conclusion soon.
Yes, just because the market is forward-looking doesn't mean it's always right. Their valuation is just a result of investors assigning them a higher chance of approval.
Maybe they're right. Maybe they're wrong. I don't know much about the company so I can't give you a guess on how likely they are to beat placebo and get approved.
The bar is certainly not set very high though. All anyone has to do is slow the decline compared to placebo.
They'll have to raise money next year regardless of what data looks like, so I doubt we'll stay below 15 million outstanding shares for long.
My guess is they will need at least $100 million to pay for all the planned trials plus other costs, which means exercised warrants can only pay for some of that.
Market is forward-looking and will take this into account when valuing the company.
Overlooked and undervalued if results are positive, not so much if they miss again.
Fully diluted market cap is about $80 million now, which is similar to what Annovis is worth for example.
Don't forget that outstanding shares will almost double if results look good.
Dr. Alkon has always been optimistic about timelines (and the science). Last year he claimed the trial would be finished middle of this year.
My guess is it will take about 5-6 weeks after they announce dosing conclusion, so if we don't get a PR before Thanksgiving I'll assume they're announcing data in early January.
From their 10K:
"As of the date of this Annual Report, we have four full-time personnel, including two of our three executive officers and two employees who are primarily engaged in research and development activities."
That's 2 or 3 employees responsible for double checking the data from about 100 different patients, and most of those employees are in their 70s.
No way we're getting that data before December 19th.
They don't have to, but since they did it for the last two trials I don't see why they would suddenly decide not to do it this time.
My guess is they're delayed and will announce it next week at the earliest.
Back in 2017 they said that they would announce results in April but ended up doing it on May 1st, so maybe it's the same this time. They say early December but it ends up being late December or January instead.
They probably just forgot to update that part. They made it clear in their presentation that the Fragile X trial isn't happening until next year.
Same reason why they said they had $29 million during the presentation when it's actually $26 million.
Some notes on the 10Q:
- They have $26 million in cash
- There's 6,848,047 shares outstanding, which is 7,418 shares more than on August 5th
- They're paying investor relations consultants with a combination of cash, restricted stock and warrants
- No updates on any trials
It is unusual for them to not have announced dosing conclusion yet. Maybe the topline data will be delayed to late December or even January.
Depends on the market. Index funds have over 200k shares they can unload if markets turn sour.
Looks promising. Official trial completion date is tomorrow so the data should be ready any day now.
It's a shame they didn't include other test scores as a secondary endpoint at least.
The SIB only goes to 100 and these patients will start the trial at over 80 and even 90 in some cases, which means any non-responders will have an outsized effect on the average.
Even if the drug works as expected, they have essentially put a cap on how much of an improvement they can get.
I'm pretty sure both trials included completer and mITT results.
One method tells the story of what actually happened. The other method tells the story of what was expected to happen if the dropouts hadn't dropped out.
Completer data is more accurate because it only includes patients that completed the trial while ITT/mITT includes dropouts by adding missing data through extrapolation based on existing data AFAIK.
Can't be sure about that either. They're allowed to take concomitant drugs but it's not a requirement. Some might not be taking any other drugs.
There's definitely some huge potential here, but I think some posters seem very certain about something that's still very much uncertain for the next 5 or so weeks.
If the market dips in a big way I wouldn't be surprised if we dip below $6 before results.
If they get 4 points or less (over baseline) after 28 weeks it will have failed to beat Donepezil. I think they need at least 7 points to get that positive slope which would confirm their MOA since they already got 6 points after 15 weeks in the #202 trial.
Beating placebo should be enough for approval, but it won't be enough to confirm their theory of reversing the disease if they can't beat current SOC.
As for the data, I assume their database access is restricted until the CRO adds the final data point and locks the data set. The independent observers probably have some limited access to safety data or baseline data but not anything else.
Add 28 weeks to April 19th and you get November 1st, so maybe the PR drops on Halloween.
"The trial blinding must be maintained until all data sets are locked. Until then investigators, site staff, sponsors and most other participants must not be aware of the treatment patients are receiving. However, there are certain functions like clinical supply or safety that require access to unblinded data. Having detailed standard operating procedures (SOPs) in place is imperative. This ensures a standardized, documented approach on access to unblinding information is appropriately restricted to authorized individuals throughout the lifecycle of the study."
https://www.clinicalresearchnewsonline.com/news/2018/06/08/avoid-unintentional-unblinding-in-clinical-trials
The data is still blinded because they haven't received it yet, so they're still "blind" to it.
Once you take a look at how the patients are doing you have "broken the blind" or "unblinded" the data.
Here's what I got from it:
- They have not received the data yet
- Dr. Alkon anticipates topline data will be out either the 1st or 2nd week of December
- They have $29M in cash and expect to raise another $20M after topline data
- They expect to run the P3 trial with their own money
- Dr. Alkon seems open to both an acquisition and partnership, but would prefer a partnership
- FXS and MS trials to commence in H1 2023
- No mention of a bioequivalence trial
Other than that, it was mostly more of the same. Personally, I think Dr. Alkon did a great job with the presentation.
Sounds about right. Let's see if we get a PR before November.
Maybe the 10Q next month will have something new to say about that. Either way, I don't think it matters much whether they launch another trial this year or a few months later.
I just double checked and it was actually about 8 weeks between the trial conclusion PRs and the result PRs. So if they announce dosing conclusion on Monday then the past would suggest they'll announce results on December 19th.
Just in time for Christmas.
I very much doubt they'll announce anything before Thanksgiving. They have always needed about 4 weeks to announce results after the trial ended.
My bet is on either December 5 or 12.
"Synaptogenix to Present at ThinkEquity Investor Conference on October 26, 2022"
https://www.prnewswire.com/news-releases/synaptogenix-to-present-at-thinkequity-investor-conference-on-october-26-2022-301653267.html
True. I'm not a statistician but the combined data does seem to show about 84% of moderate patients improving more than 3 points after 13 weeks.
Guess we'll find out soon enough if they can keep it up for 6 months.
Either way, the new data should be ready within two weeks.
Not much time left for them to announce a bioequivalence or FXS trial before results now.
There's a risk that only some patients on bryo improve while the other bryo patients decline and pull the average down for the whole group.
https://clinicaltrials.gov/ct2/show/results/NCT03560245
If you look under the Study Results tab for the last trial you'll see the slope for patients in both groups look very similar.
Both the bryo group and placebo group had 29 patients with a positive slope and 23 patients with a negative slope.
Yes. 60 is the minimum and 93 the maximum.
Wouldn't make much sense to include patients that are already at 100 and can't get a higher score.
Aricept study also included SIB scores, so it's a good way to compare Bryo against SOC even if patients can't improve more than 15 or so points because of the ceiling.
Primary endpoint for this trial is SIB change but I'm pretty sure they're measuring MMSE change on the side too.