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I didn't say my acquaintance said there were seizure events in this current trial.
This trial is incredibly short, 3 friggin months!!! Have you ever heard of a Phase 2b, let alone Ph 3, Alzheimers trial being that short??? Geee, I wonder why??? Duh, 1) it minimizes the likelihood that adverse events are gonna pop up in such a short time frame and 2) all alzheimers trials to date in ph 2 and ph 3 are longer than 3 months and for the Ph 3 trials they last at least 1 year and enroll 1-2+ thousand patients. If 3 months was sufficient all the drug companies would be running Alzheimers trials on the cheap like Neurotrope and save themselves time, effort, resources, and, oh yeah, billions 3) it is easy to get improvements within the first 3 months of an alzheimers trial, just look at any of the 4 approved drugs' trials. Beyond that, is a different story entirely.
Bryostatin does not address nor correct any of the proposed initial upstream causes of alzheimers. It only addresses a result of the underlying pathological process (synapse loss). Proposed causes include disturbance in calcium signaling (my bet is on that), mitochondrial dysfunction, oxidation, inflammation. Amyloid and Tau build up are end products of the cause(s), not the cause, so I don't count them, too far downstream.
After I posted that I regretted not including Alzheimers along with the other 4 words. I wasn't allowed to correct the post. The neurologist that reviewed Neurotrope's clinical trials and MOA didn't say unregulated synaptogenesis may increase the incidence of severe seizures and severe behavioral and pscyhe disturbances in patients with Alzheimers based on nothing. He learned that during his studies. He didn't tell me that for the hell of it based on nothing. He didn't invent it. He has no axe to grind against NTRP. He told me the drug induced increased seizures and psyche disturbance can actually be worse from a morbidity (suffering) and mortality standpoint than the cognitive decline experienced with Alzheimers. Keep in mind, every time you have a severe seizure there is brain damage that occurs. Epileptic disorders lead to more than just intermittent seizure events. There are other permanent ramifications and loss of function, such as cognitive damage.
Cancer patients are irrelevant unless they have Alzheimers. I'm not aware that unregulated synaptogenesis increases risk of seizures and psyche disturbances in cancer patients, like it can in Alzheimers patients.
Dr Alkon published a lot of papers on bryostatin, a paper hyping it for treating cancer or HIV and then another reporting its failure. Rinse repeat X39. Now he's writing papers hyping it for yet another indication. He needs vindication to redeem himself. Alkon is like A LOT of researchers, probably the bulk of them. Their drug of study is like their baby. It can do no wrong and no one can say a bad word against it no matter what. Bryostatin is Alkon's career, more than that, it IS his identity, his obsession, and life's purpose. If it were to fail, yet again, he would be crushed. He would feel like his entire career was all for naught and feel like a failure himself. And so he protects himself by wearing blinders (Like a lot of investors I might add). They lose objectivity and dismiss anything they do not want to hear. They have drunk the Kool Aid so to speak and fallen under its spell.
There is A LOT to criticize bryostatin and Neurotrope for, but you won't hear it here cept from me and Xena. In the Anavex Facebook groups investors question the drug and company to put them to the test and hold them accountable and under scrutiny, without spreading conjecture, speculation, and FUD I might add. I see you F1ash doing that ad infinitum everyday on the AVXL ihub page but narry a peep of criticism from you towards NTRP and bryostatin. Are they that pure as the driven snow?
My source? I personally corresponded with a highly respected epileptologist that runs a seizure disorder clinic. An epileptologist is a neurologist (MD) that specializes in seizure disorders like epilepsy, Rett's, etc. I asked him to review bryostatin 1 for treatment of Alzheimers. He was very negative on it b/c it doesn't address neurodegeneration (the underlying cause of the disease) and b/c of its high potential to bring on severe adverse events in Alzheimers patients. He told me unregulated synaptogenesis, as with bryostatin, increases seizures and psyche problems for patients with Alzheimers. He told me he would expect a Ph 3 trial of this drug in patients with Mod-Severe Alzheimers to likely be halted due to seizures and psychiatric issues, etc. Now, limiting the Ph 3 to just a small number patients taking the drug for only 3 months will of course greatly reduce the chances of those adverse events from occurring. The epileptologist told me patients with severe Alzheimers are screwed. Nothing can save them. Too much damage done. He did not seem at all interested in the potential of bryostatin 1 to become a viable treatment for Alzheimers.
If the drug is FDA approved, I could see it being one of those drugs that was rushed into the market too soon by the company and by a FDA given new marching orders to approve drugs quicker and with looser regulation. Then some deaths will occur and/or high incidence of side effects which will alarm doctors and caregivers. Patients will appear to be distressed, moreso than usual. Then it will be taken off the market.
I respect this particular Dr very much and his opinion, much moreso than the likes of Adam Feurstein, Jean Fonteneau, or the pundits on social media, and authors on such rags as Motley Fool, The Street, SeekingAlpha, etc. If thought brysotatin was the answer, I'd buy a large position in it. Too risky imo. I'm only talking about the science. I have other concerns too tho, such as the stock structure, upcoming dilution, etc.
Google "unregulated synaptogenesis seizures"
Question: Why aren't they keeping the Ph 2 patients on bryostatin if results were so good? Why are they only going to put the Ph 2 patients back on bryostatin AFTER the drug has been approved? Why not do like Anavex and just immediately extend the Ph 2 trial for those patients that want to continue on the drug in order to track them for longer and avoid a break in treatment? Very strange. Could it be Neurotrope fears if they keep the patients on the drug for longer than 3 months their scores will decline or, even more likely, side effects will appear?
Lets say we accept the notion that bryostatin is safe in cancer patients. So what? This trial is for ALZHEIMERS patients. There's a difference. Alzheimers patients may experience seizures as the disease advances and also behavioral/psyche instability. Synaptogenesis is known to bring on severe, debilitating seizures and behavioral/psyche changes in Alzheimers patients. It increases the probability of those adverse events. If Neurotrope would do a proper trial for longer than just a single dose or 3 months, I expect these adverse events would emerge. I'd expect that bryostatin would increase the incidence of seizures and psyche disturbances in patients with moderate to severe Alzheimers. If Neurotrope conducted a large year long trial of bryostatin for Alzheimers, I think there would be a significant chance that the trial would be halted due to incidences of severe adverse events.
Case in point, compassionate use patient Jenni Spencer experienced debilitating seizures after she went on bryostatin. She often had to be rushed to the ER during these events. During one of the seizures, I believe, she aspirated, and that is what caused the pneumonia which prematurely took her life. Would she have experienced those seizures if she had never gone on bryostatin, or experienced them to a lesser frequency and degree? A responsible, properly designed trial would have given us a better indication of the drug's safety. As it stands now, and even after Ph 2 and Ph 3, we will not know. Neurotrope was indeed shrewd to reduce the trial length for Ph 2b from 6 to 3 months and to plan the Ph 3 to be only 3 months. Sordid and suspicious imo. I've never heard of any prior Alzheimers trial lasting for only 3 months, not in phase 2, and certainly not in phase 3. And the strange handling of allowing the Ph 2 patients to continue receiving the drug, but not until AFTER bryostatin has received FDA approval, which would be a couple years from now! Makes no sense.
The other problem with bryostatin is that it does not address, nor correct, the underlying neurodegenerative disease process going on in Alzheimers. For example, it will not save the microglia and oligodendrocytes, which are the supporting framework for neurons. I do think bryostatin may mask cognitive symptoms, for a time, while the underlying neurodegenerative process continues. The question is, will it create other symptoms during that time, even more debilitating or lethal than cognitive decline?
If SLB is very low, doesn't that mean a short attack is not imminent?
I don't understand options yet. Please keep us posted. Thanks
Too many complex games allowed. Turns the stock market into a casino where $ is transferred from honest average joe casual retail investors to these predatory sharks (hedge funds) allowed to prowl the stock market looking for vulnerable victims to exploit (micro cap biotechs and their long suffering investors).
So, if your theory plays out, do you expect share price to first tank hard end of March, then explode back up as shorts cover and the price skyrockets to 52 week highs?
LOL The comparison of 2-73 to coffee was a quote from a "doctor" aquiantance of AF's that hasn't practiced medicine for years. He left the USA for Europe where he's been doing computer repair and tech support for $15/hr. Total BS. And you believe AF, the most notorious scammer and manipulator in biotech? Good luck with that. That article he put out few days ago was not neutral, it was the first cut to start the bleeding of NTRP.
Now y'all are seeing up close n personal the AF+JF+their fund friends and social media followers manipulation game. Didn't think it'd start until the uplist or the trial results release. AVXL been victim of it since Nov of 2015. It's a real shame. They target volatile, illiquid promising micro caps that have garnered investor and trader interest and experienced sizable price appreciation. Then slam them into the ground. Rinse, repeat.
How come NTRP never trades after hours or pre market?
Anyone that has studied the history of Alzheimers trials knows that you can't assess an Alzheimers drugs worth based on just a 3 month trial. All the approved drugs look great at 3 months. Heck, donepezil keeps patients improved and above baseline 3 months to a year out (the average point at which scores fall below baseline is usually somewhere between 3 and 6 months). Bryostatin will good at 3 months and this group will go nuts and shout, "Cure!", but it will be naively premature.
Funny how Neurotrope won't be resuming the tracking of the Ph 2b patients post 3 months until AFTER the drug is approved, which is over a year from now (assuming it will be approved).
Good article assessing the different MOA's of existing Alzheimers drugs in development, with mention of bryostatin. https://seekingalpha.com/article/4054680-alzheimers-disease-next
Huh, I thought the Ph 2a did show some cognitive improvement in the 6 Alzheimers patients vs 3 placebo patients according to Neurotrope. Am I wrong? No mention whatsoever of how the 3 compassionate use patients fared.
Wondered when ole AF would get around to commenting on NTRP. If he put out a negatively slanted article like this against AVXL it would be down 10%, but NTRP has gone up almost 5% since the article came out.
Lets say you own 1,000 shares of NTRP. How much would it cost you ballpark to protect yourself sufficiently with put options for the April news? Assuming the stock price is say, $30 at that time?
Couldn't a short instead just place a stop to protect them just like longs do? Why the need to purchase insurance (options)?
Fidelity has Recognia software to plot TA indicators and alert you when they spike bullish or bearish. What do you think about software that plots the indicators (eliot waves for ex) vs doing it yourself manually?
When is NTRP scheduled to be uplisted to the NASDAQ?
The previous Ph 2 trials for the failed Alzheimers drug candidates haven't been "sound". I'd say their results have been dubious to middling at best (in terms of efficacy, side effects, and adverse events). They massage those Ph 2 preliminary trials by including lots of patients which makes it easier to establish "statistical significance". They'll enroll patients that only have pre-Alzheimers disease to mild Alzheimers. They'll use all these tricks and still wind up with only middling results in Ph 2. Yet they feel compelled to do a Ph 3 to justify all the $ they already spent, hoping the FDA is so desperate for a new Alzheimers drug they'll approve anything that is a smidge better than placebo.
Anavex's Ph 2a trial only had efficacy as secondary endpoint and wasn't even designed, powered, or drug optimized to achieve efficacy. Yet, the trial has achieved multiple statistically significant scores, up to 57 weeks out no less! Soon to be 15 months out ;) No small feat, blowing away the middling, short lived results of all previous Alzheimers Ph 2 trials, that btw, were designed, powered, and drug optimized to meet primary endpoints for efficacy. Anavex's Ph 2a results have been so good that Dr George Perry, editor of The Alzheimers Journal, has said he's seen nothing like it to date.
Neurotrope has a "properly designed trial"? A Ph 2b with efficacy as a primary endpoint that is only 3 months long for an Alzheimers trial. 3 months? Alzheimers is a neurodegenerative disease btw. If all Alzheimers trials ended at 3-6 months, donepezil woulda been declared the cure a long time ago. Neurotrope has now declared they're doubling down on 3 month trials, or rather tripling down (their Ph 2a tracked patients for 3 months after administering them just 1 IV treatment of the drug). If Ph 2b results looked good, they planned long time ago to do a 6 month Ph 3 pivotal trial. 6 months is even very short for a Ph 3 Alzheimers trial. But last summer they said if they do a Ph 3 trial, they're gonna shorten it from the planned 6 months down to just 3! For a Ph 3 Alzheimers trial. No joke. They said they need to shorten it to 3 months to rush it to market ASAP to help patients ASAP. Mmmkay. To my knowledge, none of Neurotrope's bryostatin trials have included any objective tests using biomarkers. In contrast, Anavex is employing P300 and erp testing.
Dr. Alkon is not "CEO" of Neurotrope btw, Susan Wilke is. Did any of those papers he wrote result in a drug getting approved or report on that event? Or, were they just updates and papers reporting the failure of, yet again, another bryostatin clinical trial failure?
Read this link. Wish Takeda was there to see/hear Anavex. This conference is about nuturing partnerships and licensing agreements btw Asian and American/Euro biotech
TauRx is making an appearance. What do you guys think about TauRx's methylene blue compound to treat Alzheimers; I know it ran into some problems?
https://www.bio.org/events/bio-asia-international-conference/about
Over 57 weeks, P300 scores drop dramatically in anyone with moderate Alzheimers disease, a neurodegenerative disease. The fact that 2-73 improved P300 scores above baseline at 57 weeks for its 25 patients in trial is remarkable and not to be merely scoffed at and dismissed as "normal variation".
There is a race on to bring the next Alzheimers drug to market. If its the new SOC, so much the better. The sooner you can get your drug into the market, the less competition and the more $ there is to be made. It's all about the $
Is the SIB a subjective test which Neurotrope will be relying on to judge efficacy of Ph 2b? The Anavex Ph 2a was never designed to judge efficacy, that was a secondary endpoint. Ph 2a's are more concerned with evaluating if the drug is safe for people WITH THE DISEASE to take and figuring out dosing and PK/PD data. Neurotrope didn't even design their Phase 2a to evaluate if bryostatin is safe for people with Alzheimers. Oh, its been found safe for people with cancer? That's great but this is an Alzheimers trial w/people on donepezil.
Anavex runs P300 and erp tests in its trials to measure brain activity. Those are objective tests. The P300 test results at 57 weeks were most impressive btw.
Using your logic donepezil cures Alzheimers. Don't believe me, just look at the 3 month test scores for donepezil.
The longer you track an Alzheimers trial the better and the more impressive if the results show stabilization or improvement or even just slowing of the disease's progression. Why? BECAUSE IT IS AN AGGRESSIVE DEGENERATIVE DISEASE THAT ALWAYS LEADS TO DEATH! The Anavex Ph 2a trial will last 3 years when all is said and done, and that is a good thing!
Oh, Lord. Compare the Neurotripe Ph 2a to the currently active Anavex Ph 2a, still going strong at 2.3 yrs with 15+ month results to be presented at a prestigious Alzheimers conference this month, shall we. Oh yes, the Neurotrope trial had a placebo group, a whopping 3 placebo patients Lol. The "trial" consisted of ONE IV treatment given to a whopping 6 Alzheimers patients. Expansive and exhaustive trial indeed. Based on that, how could Neurotrope not possibly proceed onto Ph 2b with great haste and shorten what was expected to be an already short 6+ month Ph 2b trial down to just 3 months. Neurotrope's rationale for the trial shortening? They were just so excited about the drug's success they felt the moral obligation to rush it to market with great haste and thus shorten the trial. Indeed. Paaaahlease, spare me. Why didn't they just shorten it to another one dose trial, why stop at 3 months Lol? Real reason, odds for showing improvement or stabilization in an Alzheimers trial go way up if you keep the trial under 3-6 months because, fyi, it is a degenerative, 100% fatal disease. You cannot rescue someone that has severe Alzheimers. They are too far gone. Maybe mask symptoms for a time while the underlying etiology continues, but that's it. You give crack or heroin to a severe Alzheimers patient and guess what, they're gonna feel better, maybe dance around the room, but that doesn't mean they've been cured.
Dr. George Perry, editor of some rag called The Alzheimer's Journal cited 2-73 as best Alzheimers drug performance-wise to date. Funny he didn't mention bryostatin aven though it had been written up in his journal.
Bryostatin has been around for decades. It's track record to date despite hundreds of millions being spent researching it for multiple indications: a perfect score of epic failure in 38, or was it 39, clinical trials.
A Neurotrooper cited this write up below by Bigger Capital to, I guess, legitimize Neurotrope? But just how much trust should be placed in the article and its author? Why do I have my doubts? The article states the following misrepresentations:
1. Bigger Capital is invested in one other drug company targeting Alzheimers. It's called Promis. Promis is using monoclonal antibodies to target amyloid. Bigger wants to be invested in a company that is following that treatment approach. Umm, yah, good luck with that. Very wise investment 2. Article said Ph 1 included 9 patients with severe Alzheimers. What utter stupidity. Firstly, it was Neurotrope's Ph 2a that included 9 patients with severe Alzheimers, not Ph 1. Anyone that knows a wit about drug trials knows a Ph 1 would evaluate safety in normal controls. 3. Article said the compassionate use patients came from the Ph 1 trial. The trial he's actually referring to is the Ph 2a trial, not Ph 1, and that trial was run last summer. Sooo....how then could compassionate use patient Jenni been on the drug for over 1 year before she died? Timeline does not add up. 4. Author of article said he knows Neurotrope "very well". He said he, "...poured over ALL of Alkon's papers, and everything else published" (whatever that vaguery means). He said he even met with Neurotrope management in Boston. If that's all true, why is he so woefully ignorant about Neurotrope's drug trial, and drug trials in general? Based on this article's inaccuracies, I don't place any faith in what he or his firm says. Details matter, especially in this space.
http://biggercapital.squarespace.com/biggercapital-investment/2016/11/20/our-second-alzheimers-investment-neurotrope.html
What disuaded you from taking a position? Stock structure? Only 3 month Ph 2B and Ph 3 trials? It's a once every two weeks IV? Lack of trial results? Financing? Bryostatin having 38 out of 38 trials failed to date? They sure think it's the @#$% over there.
It'll probably tank hard after its Ph 2b results come out. Not cause they'll be bad necessarily, but just b/c NTRP is really on a tear gettin run up and sell the news is the norm now in biotech it seems. Pump n dump.
How much time have you spent digging into Neurotrope's Bryostatin 1?
Why? Because nobody's ever heard of Anavex, just went on NaSDAQ a year ago, Anavex sells no products and has no earnings, their drug is only still in Ph 2a small trial non placebo, most Alzheimers drugs fail.
Dr. George Perry editor of The Alzheimers Journal and reknowned Alzheimers researcher in his own right said 273 is best performing drug he's seen in an Alzheimers trial so far. He's independent of Anavex. Tangui Maurice, Harald Hampel like it, granted they might be on the advisory board. You won't hear anything from scientific community til well into Ph 3 at the earliest if this is groundbreaking. Aussie govt likes it, they're funding the trials, prolly not just for shits and giggles either.
in basal conditions, s1R activity triggers a moderate ROS increase, putatively used as a physiological signal
Anybody know why stop orders can't be placed for NTRP?
Has this drug, this trial, this research been scrutinized yet by the greater scientific community? Has Neurotrope presented their findings anywhere besides conferences for investors? Have their findings been pulbished in any peer reviewed journals? What was the response by the scientific community? Crickets? Have any independent, 3rd party scientists commented on bryostatin's chances to cure Alzheimers, or anything else?
How much of the Ph 2/3 trial is the Australian govt funding?
It is accepted fact that the underlying cause of Alzheimers is long term exposure to oxidative stress (free radicals). That's not my opinion. As time goes on, the accumlated oxidative insults take a toll and build up. This is prime reason for a lot of the negative sequelae associated with aging. It contributes mightily to the aging process overall. I've heard Alzheimers is a protein misfolding disease, haven't heard it is a disease of synpase loss (tho this a result of Alzheimers). The decrease in synapes is the end result of all these other mechanisms. Addressing synapse degradation is attacking Alzheimers from the backend, not upstream. When Dr. Alkon says bryostatin attacks Alzheimers upstream, he's talking about how the drug "supposedly" potentiates the action of alpha secretase to 'clip' APP so it doesn't have a chance to become a-beta. That's talking about preventing amyloid buildup, which we've discovered is not the root cause of the disease or main problem. Bryostatin doesn't stop the disease process, doesn't prevent it, it tries to address some of the effects of the disease. However, Alzheimers is a degenerative disease, so this approach will become exhausted and overwhelmed at some point.
The problem with Neurotrope is that is doesn't address the cause of Alzeimers, which is accumulated oxidative stress. What contributes to this? A lifetime of bad diet, smoking, pollution, lack of sleep, stress, etc. The sigma 1 drugs on the other hand, do address this root cause of Alzheimers, which is a much more upstream approach to treating the disease.
Sooo.....AVXL could go up, go sideways, or go down? Could you give us the probabilities for each of those scenarios, based on TA? Such as, very probable avxl will trend up, somewhat probable avxl will stay in a sideways channel, slightly probable avxl will downtrend. Or, give estimated percentages of probabilities, like 75% chance avxl will be bullish this week. That would give us more of an indication, otherwise TA doesn't help us if it doesn't forecast any probable future trends, short and long term. It is kinda like predicting the weather.
This run up from 7 to 18 in a month is hype. Reminds me of AVXL circa summer and fall of 2015. That did not end well. With such a tiny float, some high roller, or group, could slam this baby down easily.
Tangui Maurice was co-developer of 2-73. He's regarded as the world's top expert on sigma-1 receptor. Read his papers, watch his YouTube video even. He thinks 2-73 is special. Missling would not have come to Anavex if their pipeline of sigma 1 drugs were just run of the mill sigma 1 drugs comparable to the ones that have been around for ages.
Drugs in the same class are not all the same. They have different potencies, durations/half lives, side effects, receptor affinities, and actions. Example: drugs in class opiates. Fentanyl is MUCH more potent than say oxycontin.
Lol It cracks me up how people here put so much faith in subjective data on 3 compassionate use patients over an unknown period of time. And 3 months of data for the Ph 2b patients. If that's credible and rock solid, why should companies even run minimum year long Phase 2 and Phase 3 trials that are expensive? 3 months doesn't tell you efficacy and doesn't tell you side effects. It's not reliable. If it was, people would be calling donepezil the cure for Alzheimers based on 3 month data.
I ask you guys, what causes synapse loss? Does bryostatin correct the causative mechanism of that, or just try to cope with its effects on the back end?
Anavex HAS qualified why the 5 patients dropped out. Do your DD. One fell off their radar entirely and disappeared. Others had delerium and other symptoms which may or may not have been related to the drug. 5 dropouts, that's not that many dropouts for a trial of 32.
For the 38 failed hiv and cancer trials which included looking at safety of bryostatin, how long were those trials? Every clinical trial bryostatin has entered, has failed. Keep in mind, Ph 2 is supposed to show safety in ALZHEIMERS, not cancer! Ph 1 is to show safety in people that don't have Alzheimers. One IV treatment or 7 over 3 months, as in the Ph 2b trial, does not prove the drug is safe in Alzheimers patients.
Synaptogenesis can cause seizures in Alzheimers patients involving suffering and sometimes death. It can also cause serious psyche/behavioral problems for people with Alzheimers. Also, elevated growth factors over time is also a concern. I expect high incidence of side effects w/long term use of this drug for elderly people with Alzheimers.
The drug does not get at the underlying cause of Alzheimers: protein misfolding, oxidative stress, calcium imbalance, mitochondria-endoplasmic reticulum dysfunction.
Hitting the sweet spot for affinity also.