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I didn't listen but not sure how that would be the case. I guess they'll have to 8K the votes at some point
Yeah sure they have. Faked out everyone including the NIH. Most of the times drugs fail. That's why you play the risk/reward with multiple stocks in the speculative part of a portfolio and the reason some of us have been so successful. I wish results had been overwhelmingly successful, but glad to get straight results nonetheless
Sorry. No I meant 1.25 isn't the real floor. It can be manipulated downward is my take but I believe that was in the original agreement as well.
Our one shot for the financing to work out was if AD had been good. Since it wasn't I believe they will pursue non bryostatin options and all that would entail. Still hoping for FragileX but IND is yet approved per the most recent filings. All is a guess on my part.
Real question in my mind is when was open label canceled? Was it before or after we got top line results. We know it was before end of year. Something to think about.
I think the price will be a minimum price over a certain number of days leading up to a payment date which would incentivize shorting and a lower share price to cash in. That's my take anyway.
Yeah they were able to amend the previous agreement. Surprised it was only 1.25 to be honest. This thing is going to reverse split and morph into something other than a bryostatin platform IMO. I hope they chase FragileX but its a coin flip in my book as to what they intend to do.
Thanks Doc.
Doc, I don't if you'll be able to answer this or not but in your practice do you encourage blood work that extensively measures inflammatory process in the body in an attempt to lessen symptoms of illness or to better allow the immune system to attempt to heal itself, blood flow to normalize, protecting gut lining, etc...especially regarding CNS such as MS or AD or PD? I guess I'm asking is in your opinion what is the importance of regulating inflammatory responses as we age? Can supplements help with this in any real way?
Thanks for the links folks. That is interesting information to think about.
Of the 33 that entered the OLE? I'm talking about the almost 40% of those that dropped out of the 33. Yesterday's PR was for shareholders here. That's great. It certainly wasn't for new eyes or the FDA because results on 20 patients out of over 120 isn't very convincing and I'm not talking about covid. I'm talking about 20 being a small number. Looks like nearly 40% of the patients who did enroll dropped out. That's a high percentage of patients who didn't think it was worth staying on. Plus some have claimed the drug as a cure for Covid lol.
My point is, the drug likely benefits some and that is hard to come by even if it isn't that many but you have to run a trial to back up that thesis IMO. I've been hearing immediate PA for many, many years. It's now about Rett IMO and hopefully folks will know more this year. That could make the stock a nice buy. My guess is that RSBQ AUC fiasco covered up that the mean change was not stat significant so it isn't a slam dunk IMO. If they gave that number and it was stat significant, even I would be a buyer as I follow and have been dead right on that space and have been excited to follow recent developments. I doubt we ever get that number or a peer review but I'll be watching and hoping.
So that explains the N going from 33 to 24 to 20 over the course of the OLE from the original 120 or so? Are you making the claim that out of the 33 patients, nearly 40% dropped out due to covid? Not sure many buy that. Would still leave an incredibly small number to draw conclusions on an original trial that ended almost 2 years ago. Does explain why additional trials are needed. Probably explains why no peer review as we still don't have all the numbers from the original trial only some of the test scores. Doesn't explain why the CEO never alluded to this in any filing or call whatsoever but it could potentially cut down on posts in the future relating to what 95% of eligible patients really means. Not a person on this board thought the number would have been below 90, yet everyone wants to blame the FDA or cabal for never gaining approvals.
At least they have the guts to put out actual data in a timely fashion. That crap Anavex pulled yesterday was one of the most bizarre acts by a management team I have ever seen, although totally unsurprising to those that follow.
All that you stated is true, and not surprising to get only parts of data that investors expect in an Anavex "data" release. It happens time and time again. Folks still never saw the complete data from the original trial and is now designing a trial based on the parts that apparently did show efficacy. Makes sense but my question is why did nearly 40% of the remaining patients drop out during the OLE if the proclaimed efficacy results in such a substantial benefit? Were side effects that bad or are the results of the subsets not reported bad enough to negate what is reported in a large percentage of patients?
I've said for 5+ years that the drug does something but not enough to beat SOC without all the slicing and dicing (precision medicine according to many) to find a proper group to run a pivotal trial in because it does little to nothing for a significant percentage of patients taking the drug. I'm truly hopeful for Rett as up until now, there had been no approved drug and 273 appears to create much fewer side effects than trofinetidek from what we have seen. The question is that we still haven't seen full data on a larger number of patients in a format that we know the FDA will prefer to base a decision on. Praying that this will be the year for that.
Only approved drug so we'll have to see on sales. Very disappointed Acadia is charging so much. My contacts in St Louis are showing very pleased parents and results continue to improve all the way through 40 weeks, who know how much longer? Part of the synaptic MOA so maybe even more improvement. Neuren now at 1.7 billion market cap.
Regardless of their Rett sales, they are really developing the pipeline. That's what I had hoped for but alas, not very promising at the moment. Hope I'm wrong.
Like most, you don't know until you get trial data and even then can be hidden indefinitely. Was hoping this would play out the same wasly trofinetide has for Neuren. Such a similar MOA. I wish they had gone the FragileX route first but now we may never know.
Looks like some amendments to the money raise from last year. I believe they have moved the dates to begin repayment forward to mid year now, plus other covenants and "floors" and such, none of which are in shareholder's favor IMO.
As for bryostatin, this is my take. FragileX is still on hold due to more PK studies or issues. MS has made little to no progress. My guess is nothing is currently being pursued. Open Label AD study for the 12 patients was completed last year and since we got no update, my guess is nothing overly positive was discerned.
Company is well on its way toward another reverse split to maintain listing later in the year, if not sooner and company will likely spend cash on something other than bryostatin would be my guess. The fact they aren't talking about synthetic is the tell-tell sign in my book.
Only real hope is that they purchase rights to a drug that seems much more promising than the ED drug they gambled on and spun off last go around and that could be pumped back above a dollar. Like I say, that is just a "hope" at this point. Not saying stock couldn't be bought at the right price and then flipped for a profit, but longer term investment doesn't seem prudent to me at this point.
10k filed. I don't have time to go through it today but did notice the IND for fragileX was filed in December and FDA is examining things. Estimated cost of that trial is 2 million dollars fyi. If anyone gets a chance to give some bullet points, have at it.
https://www.benzinga.com/secfilings/23/03/31448156/synaptogenix-inc-annual-report-form10
Yeah I saw that. Feel bad for Axsome. They have come a long ways since I bought in the 2s
Interesting. Let's hope it doesn't cost Anavex any of their money. Let's also hope it isn't a sign of things to come for the economy.
Awesome news for the Rett community and props to little old Neuren for bringing this nearly 20 year process to eventual approval with their partnership with Acadia. First FDA approved drug to originate from New Zealand is my understanding. Will be interesting to see the pricing and follow the sales ramp up starting in 6 weeks or so. Also interesting to see what their pediatric voucher sells for. Also of note their approval is for patients as young as 2 years old. Hoping that later next year there will be 2 options approved and this will provide competitive pricing as well as serve the entire Rett population between the 2 drugs. Exciting stuff!
I saw where AXSM got caught with some money there.
Doc knows I was just kidding with him. I've been following and learning from his posts for several years now. It's rare to read posts with expertise such that he provides. Most of the rest of us are just trying to manage the best we can with the DD we can find. He's kept me on my toes many times and I appreciate the guidance. I know some appear to be scared to death of an educated opinion. It's those who I question the motive. Jmho
Thanks Doc....if you are indeed a Doc and not a hedge fund google Doc trying to steal cheap shares on multiple message boards! Good luck and God Bless. Lol
Always appreciate the knowledge in all seriousness.
That's it. Yes
I see where a director bought a nice block of shares on the open market. Up nearly 10% AH
Yeah I would like to see the exact numbers. I imagine they are working with whoever the strategic partner will be and sounds to me like a third party may run any additional AD trials. The drug certainly does something for AD patients but thus far not conclusive enough for a small company to continue spending money on IMO.
We also are yet to have transparency on the FragileX and MS trials and when they will begin if ever.
Also seems like they've been frugal with cash, likely meaning another long shot cheap drug rights situation which was a disaster last time.
Still no word on another shareholders meeting, attempting to gain approval for dilution. Payments from the note start coming due next month. Not sure today's PR clarified much other than the trial wasn't a complete failure. 10k due this week so likely feld the need to update.
Not going to happen is my guess. They aren't ruling out another drug fiasco like the ED crap last time. Still pondering what to make from today's PR myself
I typically use Pure Encapsulation's products but I think I would check out RealMushroom's Lion Mane. The good thing is Lion's Mane isn't expensive.
Sorry about your friend. I would assume the Mayo Clinic probably has the best diagnostics but if they want a second opinion they could contact Alkon's diagnistic company's test. Supposed to be over 95% accurate.
https://www.synapsdx.com/
Not sure it how it plays out now with the lenders not being able to max out their shares once the ball gets moving in April. I think they could sell shares for a few months but eventually get stopped at the 20 or 25% threshold and have to be paid interest at that point. At some time they will have to gain approval. Maybe after they get final results and show us a path forward they would be more likely to get the votes which is exactly what I told IR and anyone I know that holds shares and would listen.
No doubt
Lmao. Wonder if he has the votes
Damn. I knew I should have freed up some time to pay attention lol. Keep us updated if you hear anything Battle
I saw this. Yes very interesting. I don't take Lion's Mane supplements but may consider it moving forward.
Doc, I think once the trofinetide trial went OLE they were able to remove the meds being taken for constipation and alter the diet and from what I have read its modified the original side effects and allowed for increased improvements as time on treatment been extended. So far Acadia hasn't given guidance as to their drug pricing but so happy that in all likelihood patients will have an approved option this spring. Also interested to see if they allow scripts down to 2 years as the OLE has allowed. Hopefully 273 can be used on top of this somewhere down the line. GLTA
https://medicine.wustl.edu/news/pediatric-clinic-for-rett-syndrome-draws-patients-for-multispecialty-care-clinical-trials/
I also noticed they stated no interim data peaks. I didn't think there would be one but I know some have hoped for such.
According to today's PR, company is hopeful to complete enrollment of both trials by EOY. I guess results of the 12 month trial will read out by mid 2025, spring at the best case. I wish they would comment on recruiting of the moderate patients and if recruiting may change in light of the recent OLE trial read out.
Trading as high as 1.40 in premarket on this recent uptrend. Let's hope something is brewing.
Link?
He always goes back to what he thinks he knows but obviously none of us know for sure what all feeds into AD pathologies. That said, he could have stolen the whole NMDA overactivation theory from me since I've been questioning it since about September of 2020 or whenever the last bryostatin trial results failed top line. There is no proof of this that I know of but at the same time, I'm not sure you can count it out. If it is the case, you can just about throw any potential treatments in the trash for moderate to severe AD but the fact is once things are at that point, there could be dozens of reasons other than NMDA overactivation that could be the issue. I've always wanted to see if the many who responded so well on bryostatin had not been on memantine an extended period of time with the others pulling the overall scores down. Alkon's crew must have had similar questions since they increaswed the memantine free period substantially between trials. Of course he could have been stealing that theory from me as well (tic) lol.
As regards to BioVie, there is research on bryostatin and ERK, MAPK, and NF-kB for anyone that wants to compare the 2 drugs at least on those issues.
In summary of your original questions though, 1)not sure....2) maybe. lol
Not sure why they did it. Their 2B trial used patients 18-28.