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I'm not a conspiracy guy but I wouldn't be a bit surprised if powerful
pharma insiders are behind our delay.
So what do you think our near term future holds?
I'm in the coincidence camp.
@ July 2 Australia announced a big Alzheimer's initiative. Database and money for trials and such.
Almost simultaneously Anavex announces ok for trial start.
I believe the two are closely related.
With a trial ok'd Anavex seeks additional funds.
I believe the three are closely related.
I think with the future being precision genetic medicine a database is a very wise move. It will certainly come in handy when Anavex 3-71 comes up to the plate.
Biogen announces positive trial results.
Unrelated and really just business as usual.
Xena, If there is indeed dilution going on as of late, how might that affect your "takeover is nearly impossible because retail owns the majority" theory?
Might be nice to have a trial arm in the UK.
https://www.theguardian.com/society/2018/jul/05/nhs-clinical-trials-other-countries-envious-getting-results
I see it as a bluff, if you will.
If they're gonna do a deal, before the conference would be prudent.
You can't predict what might happen after.
We have(as Falconer so aptly puts it) a gold standard trial in our sights.
Hi Dado,
I'm trying to get a rudimentary understanding of the science involved here.
Would you say this article's epilepsy description is accurate?
TIA,
BB
https://seekingalpha.com/instablog/40909465-jdlambert/4565296-backgrounder-epilepsy-anavex-life-sciences
When might we find out where the money is coming from for this trial?
As part of the planned international study, North American sites will be added.
Does this mean places like Japan and Germany might also have sites?
Holy cow, I forgot about the insomnia aspect.
"As part of the planned international study, North American sites will be added."
Do they need FDA approval to run trial in U.S. or should I be thinking Canada/Mexico?
Could FDA approve based on Aussie/North American results?
Despite our renewed collective impatience, I think Dado's forecast of 2020 will probably be spot on too.
Lots of time for the shorts to fidget tomorrow.
Think we should scoop up some more for the gap up Thursday morning?
More on the personalized medicine front.
https://www.bbc.com/news/health-44338276
What about the increased risk of lung cancer?
It's not an accident you're allowed to transition off the front lines at a certain point.
My knee jerk reaction was "Well played, Pfizer!"
If I wanted to exit a space I wasn't making good headway in, doing it on the heels of competitors trial failures (I believe there have been several lately) would seem to be a good plan to me.
Then why not tell us us last year?
I think it would have been universally applauded.
Not putting all your eggs in one basket and all that sort of thing.
But that's just another theory.
And a fine one it is.
There are many fine theories on this board.
I (and perhaps some of you) have ridden a few biotechs down deep into the canyon.
And all the way down hope springs eternal.
Humans love stories and Anavex is a story stock.
I try very hard to avoid story stocks but I'm human and here I am.
You ask what happened.
I'd love to know too.
I'd also like to know why instead of a PD trial starting in late 2017 suddenly we're fixing to file in Europe.
I believe that deserves a thorough explanation.
I also scaled back to a more reasonable position.
To be fair, my seriously oversized position was, of course, my doing.
But for me, a bit of the luster is off the rose.
ANY other company that was still saying in November, 3 trials by years end
and failed to deliver without a articulate explanation and gone I would be.
Nonetheless, I feel better with the smaller position and if Falconer is right I'll be wealthy anyways.
Regards,
BB
Would you mind sharing your valuation calculations of Anavex?
Regards,
BB
Good point.
I know what you mean, my mom has entered one recently and I hear about the pills often enough. Unless, of course, she forgets to tell me.
But wouldn't trial participants be a horse of a different color?
After all, they did sign up.
We've been here before.
Let's say you're one of the trial participants.
You received no benefit when the trial comes to an end.
There are no other viable options.
Are you really going to stop if the option to continue exists?
Why?
Good article on Right To Try.
http://www.mauldineconomics.com/tech/tech-digest/right-to-try-our-best-shot-at-saving-healthcare
I think it's the no signal or a suspect weak one.
They're searching for anything to give them at least slight edge.
I used to handicap greyhounds and as long as I bet the right track, grade, day, time or season where I had a slight edge I made money.
Lacking that edge I think they'll just run them with the general population and hope for the best.
A reasonable plan I suppose.
I sold some last week at 3.41 and again at 3.08.
But I was seriously overweight and I'm simply reducing to a more sensible level.
Maybe some of the selling as of late are others like me.
What do you think that means?
Has anyone reached out lately to the Rett syndrome people and asked about the status of the trial?
I know they've responded in the past.
I was referring to falconer's pointing out that no one from the scientific community has disputed Anavex's claims.
Do trials often face scientific adversity?
This post might be worth a sticky as it would be helpful to new investors.
This brings up a question I've had for some time.
In the thousands of various trials that have been run thus far, is it common for naysaying by the scientific community?
If not, than the lack of it would not be unusual.
What's the difference between faith and rock solid conviction?
I would think a cure would do less lucrative than ongoing dosing.
You raise a very interesting point.
If Missling was replaced would we sell?
I don't believe I would.
I think he has managed the money/shares very well.
Everything else? Who knows? We aren't told very much.
Question for a very chilly New Years Day:
What would be a barely acceptable buyout price this coming week?
For me it'd be 4 billion.
I'd use 1/4 of the proceeds to buy shares in the acquiring company and head on down the investing trail with the rest.
Quote from a Charlie Munger interview pretty much nails why I'm currently overweight AVXL.
"And the one thing that all those winning betters in the whole history of people who’ve beaten the pari-mutuel system have is quite simple. They bet very seldom. It’s not given to human beings to have such talent that they can just know everything about everything all the time. But it is given to human beings who work hard at it—who look and sift the world for a mispriced bet—that they can occasionally find one. And the wise ones bet heavily when the world offers them that opportunity. They bet big when they have the odds. And the rest of the time, they don’t. It’s just that simple. That is a very simple concept. And to me it’s obviously right—based on experience not only from the pari-mutuel system, but everywhere else.”
Who also has no experience running trials.
Seems to me if we're such a "shoo-in" as many here believe, the old trial protocols would have been just fine.
Perhaps we would already be approved for Rett.
The FDA Is Approving Drugs at a Staggering Pace
October 6, 2017, Bloomberg
The U.S Food and Drug Administration, under Commissioner Scott Gottlieb, is taking advantage of policy groundwork laid in past years to speed drug approvals. Thirty-four new drugs -- treating everything from cancer to rare genetic diseases -- have been approved so far this year. That’s on pace to nearly double last year’s approvals. So far, at least nine decisions came more than 20 days ahead of the FDA’s scheduled action date.
Wall Street is paying attention, with some portfolio managers shifting their strategies, anticipating faster approvals and less restrictive labels.
The agency stresses that the changes to increase speed aren’t at the expense of safety.
“The FDA makes decisions based on consistent, rigorous scientific principles,” said spokeswoman Sandy Walsh in an email. “We’re always implementing reforms to modernize and strengthen how we determine safety and effectiveness, while also making the drug development and review process more efficient.”