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The dose response Missling was referring to was PR'ed last winter. Dose response was calculated for MMSE and P300. That is old news based off of the 5 week data.
When Missling said the #'s were impressive at the Bio Investors, was he speaking of just the 5 week results and interim 12 week data which have all been PR'ed long time ago, or new data beyond that that we aren't privy to?
If so, why didn't Missling and Anavex rush 3-71 instead of 2-73? Do you think 2-73 and 3-71 could work additively together or would they simple be competing with each other?
dude, you haven't held a year. Look at the s&p for the past number of years, it has sucked, yet still people are investing $ into their 401K growth funds. If the stock is where it is at now 5 years from now, then complain
I've read 50% of the funding of the FDA comes from drug companies. If true, would FDA favor its BP donors over smaller companies like Anavex? I wonder if there is a "revolving door" between BP and the FDA? An exec from BP getting appointed to a high ranking position in the FDA and then going back to BP at a later date. Congressman Billy Tauzin is an example of that revolving door.
Many trials, even for Alzheimers, look good in Ph 2 but fail in Ph 3 - McFarlane. Why is 2-73 different?
Tell your reps to send a message to Mary Jo White, head of SEC, to look into coordinated rampant manipulation of AVXL
so he's not in the current trial since he doesn't have alzheimers? why was anavex mentioned if he doesnt have alzheimer's?
who's ppietrz yob?
Amyloid protein that folds clumps with other folded amyloid to form a plague. I think these plagues encourage Tau protein to clump forming Tau "tangles". These tangles are the bullet that kills the neuron. PBS doc on alzheimers last week described this theory. The amyloid plagues, I thnk, interfere with propagation of an electrical signal (action potential) from neuron to neuron. That means neurons can't effectively communicate with each other which impairs cognition. 2-73 prevents the folding of amyloid in the first place, whereas the antibody drugs just clean up the plagues AFTER they've already formed.
Don't Friday's tend to be green b/c shorts are less apt to be short of the weekend?
Missling said this regarding the Part A results, "...the positive dose-response in PART A is an encouraging step and also consistent with the fast mode of action of the sigma-1 receptor.“ Since 2-73 has shown impressive improvement early in the trial, do you suspect it has peaked already? Donepezil peaks at 12 weeks and then patients decline.
1 week from now will price be above or below current?
But I wonder who told The Herald the 4X figure? McFarlane? Would he say 4X better than donepezil if the new data doesn't support that? I'm assuming he's privy to the new data?
"It shows a huge improvement in the cognitive ability of the patients, with the drug so far proving to be four-times more effective than the current treatment." Wonder if they are basing that off of old data (the interim Part A P300 being 4X better than donepezil last July) or new?
All the abstracts I've seen for that conference look like typical abstracts included in scientific papers/articles published in scientific publications. I don't think Anavex has ever published a formal scientific paper for 2-73 published in a journal, have they?
the 'holy grail is seeing improvement, or at least halting decline, beyond 12 weeks. no drugs have done that yet in clinical trials
Why? Is it mandatory conference presenters submit an abstract? And if so, Anavex's might be vague and make no mention 12 week or 26 week results, either b/c they aren't in yet or b/c they want to save that for conference.
i thought the conference putting submitted abstracts on their website for public viewing
Nice focus on 2-73. Author works for UCB Pharmaceutical in Belgium.
Yeah, hedge funds like to target promising low float biotech because they're volatile. If a biotech sucks and nobody's buying and its PPS is organically in the doldrums, it isn't as lucrative to short down and it'll just get shorted into the ground quickly, thus ending the game quickly. With Anavex, there is always buying, so the game can be repeated over n over for months-years
Anavex's sigma 1 pipeline is the only thing that brought missling to the company, he said.
But couldn't their drug prove to be competition down the road?
Isn't their drug(s) a threat to Anavex? Competition in same class
"At the end of the 52-week follow-on study with capsules, Anavex will test the patients for cognitive impairment. Without a control group for comparison, they'll probably be positive" - Motley Foolish article. HOw the hell does the author know there will be improvement at 52 weeks? How presumptuous and what a @#$%ing asinine thing to say. He's just trying to set Anavex up since he can't attack it on its results.
You missed the point I tried to make. In the Ph 2A trial, patients had been on donepezil probably longer than 12 weeks before the trial even began. We know after 12 weeks, DONEPEZIL DOES NOT WORK. Take a patient that has never been given donepezil in their life, give it to him along with 2-73, then evaluate for synergy between the two. That is fair assessment and replicates how the mouse studies were run.
But the mice had not been on donepezil previous to when they were put on 2-73 and donepezil. In the human trial, I'd bet most those patients had been on donepezil longer than 12 weeks pre-trial, and after 12 weeks, donepezil doesn't work. By the time our human trial began, donepezil had already 'shot its wad' in our patients.
But would 3-71 work additively with 2-73 targetting the same receptors or would they compete w/each other, thereby negating the other
When did they acquire the license for 3-71? 2-73 was further in development than 3-71 and they acquired it earliar.
my guess is 3-71
3-71 is smaller than the already small 2-73 and it is more potent (ie a tiny dose has great effect). I have high hopes for it. It doesn't metabolize into something that is active (therapeutic), which 2-73 does. I think 2-73 is like two drugs in one
ir said anavex doesn't have the data, so he's not even able to show it to bp. remember, it took months for the 5 week dose response (pk/pd) data to be released after ctad
New data presented Italy, May 15-19, 2016. I guarantee it
Interesting it includes H! antagonists (meclizine and hydroxyzine) since they are anticholinergics and linked to increased risk for getting Alzheimers
The thing is, Anavex has said repeatedly that it would release the results just as soon as they are available. I take "available" to mean that the stats have been run, as well as PK/PD, and summarized.
Who's doing the number crunching for Anavex? McFarlane & Co., Anavex itself, or some outside firm Anavex has hired? Whoever they are, they are so frigging slow, I mean, how long does it take to run some stats, do PK/PD (whateve that is), and prepare some slides? Months, years?
Some say, oh, Anavex not releasing data b/c they're in talks with BP. So. Why would that cause Anavex not to release their data publicly?
No cause it'll take months for the 26 week data to be analyzed and have the PK/PD done
Looking at slide 16 from the AAT conference last week in Athens, there are only 25 data points. Aren't there 30 patients in the trial? Where are the missing 5? I guess MMSE wasn't obtained for them at 5 weeks?
Hold up, I thought donepezil's MOA for Alzheimers was attributed to it being an acetylcholinesterase inhibitor, not a sigma 1 agonist. What does it coincidentally having sigma 1 binding affinity have to do with the Anavex Plus patent? I've never seen its sigma 1 affinity brought up as having anything to do with its therapeutic effect.
I don't want to pressure Anavex to alter their timeline or plans. They've hired a hedge fund manager and I'm sure he knows how to deal with the "funny business" and investor expectations. Missling should as well. But they're thinking long term big picture, unlike us. All this stuff we're nitpicking over and parsing, they aren't as concerned with imho