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Not sure I follow.
If they have been trying to solve this puzzle wouldn't they have higher and continuing incidences of side effects as they failed in various ways?
I love when the TA'ers fight.
It's like mud wrestling to me.
Someone (Xena?) suggested the FDA would want all the arms to start at the same time.
Terrible. But thank you for asking.
I thought I mentioned I was greedy?
And what an odd mix it is!
I trying to think of another instance where greedy people (of which I'm one) and humanitarians have interacted so frequently and cordially.
Spent some time on Google this morning trying to ascertain whether Rett and Parkinsons sufferers have sleep issues.
The answer is yes in both cases.
Is it possible this could be a secondary endpoint in one or both of these short trials?
Is 12 weeks long enough to prove therapeutic value for sleep disorders?
I'm starting to cool a bit on the Parkinson's Europe thing.
A few years back I owned shares in a company(AVXL) that had a novel erectile dysfunction drug approved in Europe.
But still, each member state had to vote on it, usually at a predetermined time when they vote on such things.
This took forever and some said no.
And then, while the European approval was enough for Latin America and parts of Asia, all the individual countries still had to vote on it.
Further, they partnered with several different companies for marketing sales and distribution depending on the region(not sure if this is the norm).
I realize ED and PD aren't the same animal, but unless we damn near cure Parkinson's we'll be just another treatment.
How about Anavex does a MTA with Biogen,Biogen says interesting, but we're going in a different direction.
Anavex takes MS off the pipeline.
Not such a big deal considering all the irons in the fire.
Now Anavex sees a new way forward (currently unknown to us) and MS is back in the fire.
Considering European PD came out of the blue, I'm not sure anything should surprise us.
Being international is intriguing.
P.S. I hope you're right and I'm all wet.
Much bigger money your way.
My average cost is $4.74.
One of the things I love about the stock market is that two fellow investors can be in totally different situations whilst owning the same stock.
I wish I could join you but the sticky note on my computer that says "losers average losers" reminds me I am only to buy into strength.
I think the best solution to this dilemma is a long steady increase in share price. Then we both will be winners.
Regards,
BB
I believe if Missling had said in the beginning, "Rett here.Pd in Europe
and AD here and Australia" I would have been thrilled.
For all the hype about the new FDA it could be an abysmal failure.
It wouldn't be the first time.
This way, all our eggs aren't in one basket.
I'm happy it's playing out this way.
Thank you.
Any thoughts what he meant here timelinewise in regard to MS.
Christopher Missling
We are moving forward with that program as well. We will update once we have better clarity on that in the close of the coming year.
Christopher Missling
The IND was filed for Rett syndrome and we are expecting any day of the feedback from the agencies. So, theoretically this could become still a 2017 stop and the Parkinson will likely be a quarter in 2018 because the submission will be in early 2018 - in the first quarter 2018.
From Q & A.
Is "This will be now a European trial" a correct sentence?
If you change it to "now be" he might be right.
I've sat through some investments that stumbled and fumbled their way to nonexistence.
Sitting and waiting on AVXL is a cakewalk.
If I ever get around to starting that CEO training seminar I've planned on, putting heavy emphasis on saying "tip of the iceberg" ranks at the top of my list.
It seems to have magical effects.
Always worried we'd be squashed, like the stories we used to hear how some guy invented a car that ran on water and then we never heard about it again.
If the science proves out, our light should shine bright.
I think it's great because my paranoid side worries the behind the scene, powers that be, could put up some roadblocks considering the enormous impact
A-273 might have on the medical world at large.
A European trial de-risks this somewhat in my eyes.
This is something I've pondered.
Through my recent reading I've learned aluminum was "discovered" in about 12 different places around the world at roughly the same time.
And a second person applied for a telephone patent the very same day Bell did.
And Bill Gates luckily attended one of the few high schools with computers.
If he hadn't, within a short time one of many brilliant young minds would have created what he did.
I think we're in such a time now.
Between high speed computing, AI, and the internet, medicine is on the cusp of monumental change.
We don't know why for sure but you're sure right about the end result.
For Alzheimers, I wonder if Australia pays for the bulk of the trial participants and we pay for a U.S arm.
Considering we have specific criteria which would result in a smaller pool of potential participants why wouldn't it take even longer than average to get the number we need?
In regards to no.4.
Has it ever been explained how the ph.2 trial was designed to fail quickly if at all?
This is often quoted and seems comforting to some.
Was it the on, off, of on again dosing?
Was it the finding max dose?
Or something else?
Please document.
"Rett was supposed start way in the past."
Officially, Anavex stated sequence is release PK/PD data-Rett-PD-AD.
So far they're batting 100% and you're batting Blutarsky's grade point average.
Maybe the FDA is saying "Go ahead. WAIT!" "Go ahead. WAIT!"
Thanks. Do you think this is just a continuation of the early Nov. roadshow?
And as long as I'm asking, what are your thoughts on Dr. Missling's recent buying program?
In regard to the comparison of the end of his previous purchase plan and the end of this one is there a similar timeline thing or have we passed that?
Regards,
BB
I read this board regularly but the mention of upcoming road show is new to me.
Help please?
I understand what you're saying but the reporting is to be done by caregivers. Probably moms and dads. People who might give everything they have to see their little girl improve.
I would never accuse them of lying but neither would I fault them for seeing what they're so desperate to see.
I'm not nearly as big a fan of the caregiver aspect as some on this board are and I expect to see scandals and/or questionable drugs approved because of it.
It should stay science only. precision to be sure, but just science.
Exactly what do you think a placebo effect is?
A different type of Alzheimer's trial starting soon.
https://www.bloomberg.com/news/articles/2017-11-29/pulling-iron-from-brain-seen-offering-hope-in-alzheimer-s-fight
But why?
The bar to becoming the new soc for Alzheimer's is incredibly low.
If we multiply the phase 2 population by ten we get 50 or so positive responders.
And that group was random. You gotta think 6 months ago we had enough info to get close to 100.
I don't get why 75% is so much more important than 25%.
25% gets approval.
I would think the selection process would take even longer as we're looking for very specific somethings in the participants.
Frrol, I'm addressing this to you but it is also for other posters who are neutral/negative on Anavex.
I'm not quite sure where you're coming from.
Do you think they just have a little something and they're trying to portray it as something much bigger?
Do you think they have interesting data but are unable or incapable of finding cause and correlation?
Do you think it's an outright scam?
Do you think there's something going on behind the scenes at Anavex that no one has brought up thus far on this board?
Or, of course, are none of the above your thoughts?
Do you think today's science is capable of answering these questions you raise with a high degree of accuracy?
Any chance Biogen is also waiting for the new FDA guidelines to announce a partnership and/or trial with Anavex?
Stunning!