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The talking heads in the media won't mention Anavex until AVXL is $50+ and 2-73 is post Ph 3 and waiting on FDA approval. They're always late. The insiders know the real deal early tho. That's why so much of Missling's compensation is AVXL stock. BP pays networks lots of $$$ to run ads. The media conglomerates like that $$$ and want to keep BP happy.
Whaddup with NTRP? It ain't trading today?
NTRP pump & dump part deux. Do I chance to ride the lightning once more? Hmmm
I suspect these similar age related diseases have build up of oxidative stress as the commonality. 2-73 addresses that through modulating ca++ across the plasma membrane and membranes of the intracellular organelles (ER, mitochondria).
What's your take on Aducanumab's results written up in Nature last August? Supposedly, at the highest dose given in the Ph 1b trial, all the amyloid/a-beta was removed from the brain and cognitive decline was slowed or halted (I'm not sure which was case). High incidence of brain swelling, esp for patients on the highest dose (10mg), tho Biogen said that swelling resolved in the patients during the trial. Not sure if it is of consequence. 40% drop out rate during the trial for various side effects. Trial only involved patients with MCI and mild Alzheimers. Biogen feels the key is giving the drug early before neuron death happens. The drug is a shot given once/month and would cost about $40K/year. Their next trial for the drug should finish 2020 at the earliest and enrolls 1350 patients in the UK.
Riiiiigt. That's why Anavex hired Corinne Lasmezas, top expert in prion disease, b/c CJD isn't at all relevant to its pipeline.
Below is link to a short talk Corinne Lasmezas gave on neurodegenerative diseases and prions. She explains how they are related. A prion is just misfolded protein and misfolded proteins are present in neurodegenerative diseases. Lasmezas is one the world's top prion experts and she was one of the point persons consulted during the Mad Cow outbreak in Britain 15 or so years ago. She was appointed to the Anavex Scientific Advisory Board a year or 2 ago. I've also heard her describe Alzheimers as a mitochondrial disease.
Corinne Lasmezas vid
Correct me if I'm wrong, but of those that completed the 3 month trial, their group MMSE score was 1/2 the improvement observed in mod-severe alzheimer's subjects taking donepezil. And of the 150 enrolled, how many dropped out before the end date of this trial? As I recall it was a rather high number, especially considering the trial was only 3 months. Wouldn't have had anything to do with side effects or adverse events?
But that's obfuscating the fact that she was only on the donepezil for 2 months, and she was only on 10mg of donepezil for 1 month. Whereas the Australian woman had been on 2-73 for 8-9 months when her interview was filmed. You conveniently failed to mention that nugget of info. And the Australian woman might not have even been on what will be determined to be the optimized dose of 2-73. Everybody knows donepezil's improvement is short lived, just a few months. That's why abbreviated 3 month trials for Alzheimers are deceiving. Seeing improvement or stabilization more than 6 months or one year out, now that is impressive.
Have you invested in AVXL?
My mistake, my last post was incorrect. Sorry
Til this month, I believe all trial participants have been kept on the same dose from the start of Part B. This is merely an extension of Part B not so much a new trial w/new parameters. That said, this month, patients on 10mg have been allowed to move up to 20mg. I get that b/c the trial has shown that 14mg is the minimum theapeutic dose. I'm sure those 10mg patients want to be taking more than 14mg. Not sure why 20mg was chosen for them to move up to and not 30 or 40mg. I'd be shocked if only 20mg turns out to be the optimal dose. Maybe Anavex wants to bump them up to just 20mg and observe for effect before bumping them up another 10mg two more times.
If your post is accurate, only 3 out of the 7 dropped out due to reported mild side effects (probably b/c they weren't on an optimized dose imo). Not bad over the course of 57 weeks (part A + part B of the Phase 2A trial). The other 4 probably dropped out b/c they couldn't comply with the demands of the trial or they didn't experience substantial, noticeable improvement after several months (again, possibly b/c they weren't on an optimized dose) .
Keep in mind, Part B was only planned to last 6 months. All those that completed it requested an extension of the trial so they could stay on it. Anavex extended the trial to 1 year. At end of 1 year, all those completed Part B requested to stay on the drug. Anavex allowed that, provided Anavex could continue tracking them for another 2 years.
Interestingly, with the two ladies from the trial highlighted on Aussie TV, they were interviewed at 8-9 months into the trial. The man they showed on TV, I'm not sure for how he had been on 273, 8 mos to a year I think. I think when all 3 were interviewed they hadn't yet started to slide back down after making improvement. Whereas with donepezil, patients start to slide back down after 3-4 months and after 6 months, they've usually dipped below baseline and just keep falling.
Of the 7 dropouts, I know at least several complained of neuro issues (I think those included: dizziness, disorientation, headache, concentration problems). Whether those symptoms were related to the drug or not, IDK. I'm not sure why they dropped out. Perhaps they were on too high a dosage given their body type, physiology, comorbidities, age, and sex? I think administered dose strengths spanned from 10mg to 50mg. It was determined 14mg was the minimum therapeutic dose. Doubt anyone will be on that or lower for Ph 3.
"the stuff is utterly safe"
Well, there were 7 drop outs were there not?
Assuming 2-73 is approved, if Anavex Plus (2-73 + donepezil) is priced similarly to 2-73, won't doctors rx Anavex Plus and keep patients on it as long as they don't experience side effects? In that case, vastly fewer prescriptions will be written for donepezil or Aricept.
You mean I'm usually right. I said that NTRP would fall surrounding its uplisting to NASDAQ. It did. I said NTRP would tank on Ph 2b news. It did. I said it would drop to $9. It did, and then some. Sorry I underestimated just how low it would go by a couple dollars, but that is not a lie. I said y'all and Neurotrope are over hyping bryostatin and ignoring its likelihood to cause side effects and adverse events. The results of the 20 mg group for SIB were only half the improvement of Aricept. Full side effects were not even released. Just a mention of diarrhea, which is a BIG deal in elderly compromised people whom are susceptible to dehydration. A big knock on donepezil is that it often raunches the GI tracts of users. Same seems to be true for bryostatin in Alzheimers patients.
If you think this is a P&D stock, which I'm in agreement with, why didn't you, nor few others on this board cept for me and Xenia, warn would-be investors that that was the case a month ago during the pump? Whenever I'd suggest that, I was rebuked and told the results would be so impressive, unprecedented, and conclusive that a dump surrounding the news would not happen. There was a lot of hype and outlandish predictions made here during the pump. I'm sure that lured many people to invest in NTRP when the price was $15, $20, $25, etc. Now, those same investors are in the red large with their NTRP position.
Jenni died prematurely from a seizure induced pneumonia. IMO, the bryostatin contributed to her frequent seizures, which significantly lowered her quality of life and lead to her premature death.
Neurotrope will not do long trials with this drug b/c they know long term administration will likely bring side effects galore. I think Jenni experienced that.
I should not have said "....in a pill" since bryostatin is delivered IV
Oh, I HIGHLY doubt the release of that abstract would "pump" the stock. It's meaningless. Show me how a larger trial's MMSE scores fare over 2 yrs, not 3 hours, on Neurotrope's pond scum in a pill.
Incredibly impressive? Seriously?
Onward with the pump and dump! How many suckers, err investors, have yet to be rooked by NTRP? How many that invested during the last pump are now massively underwater? I wisely had a stop loss in place which removed me from NTRP during the dump surrounding the NASDAQ uplisting.
I'm maybe targeting reentry at $5 to trade this stock. However, I think this stock may trade in a $5-12 channel for the next year or two. So, I might wait until then to reenter if the stock moves above that channel during the next steep pump, if that happens again
My first prediction made several weeks ago was that NTRP would fall to $9 after releasing disappointing trial results. This ihub group dismissed that prediction as laughable and ridiculous. Maybe I owe y'all an apology b/c it didn't fall to $9, it crashed to $6.76. My initial plan was to reenter at $9 and establish a trading position. I haven't done that. Considering reentering at $5 now. Could the bottom be lower than that? I underestimated how low NTRP would go the first time. Don't wanna make that same mistake twice.
Those aren't just claims the Seeking Alpha author pulled willy nilly out of thin air. They're based on well run studies that have been published in peer reviewed journals.
Have you read the entire piece? I suggest you read all of Lane Simonian's write-ups on Seeking Alpha pertaining to Alzheimers.
The MOA of bryostatin is contraindicated for the treatment of Alzheimers, according to this Seeking Alpha piece. Activating PKC, which is what bryostatin does, actually does more harm than good, especially for those with mild to moderate Alzheimers.
https://seekingalpha.com/article/4071722-alzheimers-disease-40-years-wilderness
TA is about predicting what a stock's price is most likely to do. Otherwise, what's the point? Saying, "AVXL could go up to a, b, or c; or AVXL could go down to x, y, or z", isn't really TA imo. It's more than just laying out multiple possible levels of resistance and support, which isn't useless information. However, TA isn't that vague, it's more specific about the direction the price is going to move.
I highly doubt that. You conclude that the failed Ph 2b trial was a success, so our definitions of what constitutes a successful clinical trial are radically different.
Which drugs has Alkon ushered into the marketplace from the preclinic to FDA approval? I'm sure there are many of them if he's written 282 papers on successful clinical trials.
Of those 300 papers Alkon has contributed to, how many involved successful clinical trials?
IBB down 2% or AVXL would be up even more today. Since 3 months ago, IBB up 2%, nasdaq up 7%, and AVXL up 14%. Breakout in progress.
Since the 273 Alzheimers trials are taking place in Australia, and the Australian govt is funding the trials, isn't it more likely 273 will get approved there 1st, and perhaps in other countries, before the US?
Anavex elected to do the trials in Australia b/c it is a faster, easier process (ie less red tape and hoops) than in the US. I wonder if the same applies for drug approvals?
Refer to this post by orveko_inc from last July.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=123682369
He lists all patent apps pertaining to Anavex. Orveko had this to say:
U.S. patent application 14/395581 - As it relates to A2-73 or A19-144, this patent application, if granted, would cover a method of treating Alzheimer's with A2-73 or A19-144 when combined with either rivastigmine, galantamine, or donepezil.
U.S. patent application 15/194792 - Title and information not yet known, however this patent application is a child of both 14/395581 and 14/865862, so is likely related to Anavex 19-144 and/or Anavex 2-73.
If someone has moderate to severe Alzheimers, you can bet they've been on donepezil, memantine, etc for far longer than 3-6 months. After 3 months, those drugs have lost their punch and scores decline, so I doubt they're doing much of anything by the time someone reaches the moderate to severe stage
Very fishy how poorly the placebo group fared in this Ph 2b compared to other similar trials where placebo group barely fell below baseline at 3 months. This trial's SIB scores were disappointing. So bad Neurotrope didn't have the guts to release the scores for the 40 mcg group. As Derek Lowe's Seeking Alpha article points out, trials of Aricept posted +5 SIB at 3 months, compared to bryostatin's +1.5. In the Aricept and donepezil trials, placebo groups barely declined at 3 months for SIB, whereas in the Neurotrope Ph 2b, placebo group declined by over a point, rather unusual and fortunate for neurotrope's trial for the placebo group to fare so poorly, nonetheless, the discrepancy between bryostatin's gain and the placebo group's decline was still only half the discrepancy between Aricept and placebo group. *If* a Ph 3 is carried out, and if the selection, testing, and scoring of the placebo group isn't fixed, I doubt it will decline as much as the Ph 2b placebo group.
It's incorrect to compare Ph 2a trials with Ph 2b trials. They have different end points, different goals, and different designs. It is like comparing apples to oranges. If you wanna make comparisons, compare Ph 2a to a Ph 2a and Ph 2b with a Ph 2b. You consistently conflate the two
I prefer the opinion of Dr. George Perry personally.
Despite Neurotrope's Ph 2b being only a 3 month trial, there was a 30% drop out rate. Did you catch how Neurotrope factored those drop out patients into their PR of the trial's results? The lack of transparency from Neurotrope is disturbing and unusual. No Ph 2a scores to scrutinize, nor scores from the compassionate use patients. Only brief mention of side effects associated with the Ph 2b, no details. No scores of the 40 microgram group released. No adcs-adl scores released. Choosing to only release SIB aggregate score for the 20 microgram group. No combined overall aggregate score for all the patients enrolled in the trial.
If you look back on the donepezil trials over the years, you'll see typically the placebo groups improve their scores at 5 weeks. That doesn't mean a placebo does anything incredible against Alzheimers Disease. I'd like to see how severe patients fare after being on bryostatin for 2 years, but Neurotrope will never let that happen before it is FDA approved. As time goes on, I expect to see more frequent and severe side effects and adverse events.
Convenient of Neurotrope to cherry pick just reporting results of the 20microgram group and not include the 40microgram group's scores in the overall results for the trial.
+1.5 at 3 months isn't that impressive when you consider donepezil has posted +4 to +5 at 3 mos in similar trials.
USC Alzheimers expert by name of Lon Schneider, MD tweeted this regarding the Neurotrope Ph 2b, "Hints of modest efficacy"? Really? Where? Their threshold was P <.1, 1-tailed (equal to P <.2, 2-tailed), not even close to hint or trend"
Utilizing a p of less than 0.1 is a joke for a clinical trial. Neurotrope should feel embarrassed that they did this.
Follow the link below, then scroll down to the SIB results for Oral Aricept given to moderate to severe alzheimer's subjects. This is for 10mg/day of Aricept. At 3 months the SIB is +5 and at 6 months the SIB is at +4. Neurotrope's bryostatin was at only +1.5 at 3 months, yet they insist it's better than SOC. Other trials of donepezil show 3 month SIB scores at +4. https://www.drugs.com/pro/aricept-oral-solution.html
The Neurotrope Ph 2b included a placebo group that deteriorated much more so, with regard to SIB, than other placebo groups in similar trials. That skewed Neurotrope's results to the good. They lucked out this time with a poorly performing placebo group, nonetheless, even with that in their favor, the results were disappointing.
Ahh, makes perfect sense. The way these jokers design their incomplete trials and present only cherry picked, modest at best results, I'm not surprised the stock is trading this AM at $9, exactly what I predicted over a week ago. Although now, I'm not sure if I even want to take a position. Probably better stocks to trade at this time and certainly to invest in. Knew I shoulda shorted this. It's gonna be a long road back to $29.
Where do you guys see the bottom at?
I'm confused, Alkon said he would like to NOW extend this 3 month trial and possibly put the 40 microgram dosed patients on 20 microgram dose. Soo...then why the heck didn't he keep the trial at 6 months in the first place?!? If this Ph 2b trial was such a success, you'd think he'd want to proceed immediately to Ph 3 as that was his plan. Maybe the data collected so far doesn't warrant proceeding to Ph 3?
No hard data whatsoever on ADCS ADL. Why? No hard data either on all the side effects and incidence and severity.
He mentioned how the 40 microgram dosed patients experience an intial impressive boost in improvement due to downregulation but this effect quickly becomes inhibitory and then improvement is lost. My suspicion is that this will eventually happen with those on 20 microgram dose too, just at a slower rate. Previously, I guessed that with bryostatin's MOA, you'd see an initial pop in scores but that improvement would fade over time and side effects would increase and become severe. Not surprising that Neurotrope didn't want to release any of the 40 microgram group's results.
Not even half the improvement of SIB at 3 months that donepezil showed. Results not statistically significant and do not meet FDA's threshold for approval. Quite a few drop outs but their results not included, nor were results reported for those on the higher 40 microgram dose. Diarrhea most common side effect, which I assume accounted for the drop outs.
Continuation of the trial beyond 3 months will, imo, yield a significant drop in SIB accompanied by more prominent and severe side effects as time goes on. As the trial went on, I believe Neurotrope discovered that that would likely be case and so shortened the trial from 6 months to just 3 to avoid worse results with regard to efficacy and side effects.
Share price ($9.6) close to my $9 entry point, but I expect price to maybe go lower than that.