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Well, it is this part that I especially posted the article.
“One such strategy is the use of natural history models to reduce the need for placebo arms in studies of therapies targeting very rare conditions. The FDA defines the natural history of a disease as the course an illness takes from its onset, through the presymptomatic and clinical stages, to a final outcome in the absence of a treatment.”
For all the Debbie’s that say placebo is a must, it’s the old way of thinking.
One important change is that FDA says it’s open to considering a novel drug for early stages that can affect cognition, or measures of a person’s thinking or memory. FDA previously said a drug had to deliver on two endpoints: cognition and function, and the latter involves an ability to perform tasks.
https://www.wsj.com/articles/cures-welcome-at-fda-1520803007
And who laughed at Netflix when they came knocking on the door? Yup, Blockbuster. Didn’t want anything to do with them.
Yes fireman.
By they remaining silent, we are to assume that it means Anavex is on the wrong path. That they, BP, the all knowing companies with endless funds are always right.
No, they don’t buy out smaller companies that take all the risk leaving them with a small portion of all the rewards.
They don’t hire desperate people to post on public boards to down right slander a company making the uninformed “think” its a bad investment, when nothing except positives have been shared since 2014.
Yes it has taken a while, but in any other scenario, we would have been either bought out on the cheap, or down in the RS world never having the chance to take a-273 to the pivotal trial.
I’ll be voting FOR this April.
Which is why retail miss out when pps REALLY appreciates.
Happens time and time again.
Surely a CEO owning 2.2 percent of the company means nothing also?
Between Park West and the Dr. , they own a little over 8% of the 44M stock available.
Neither of them selling as the pps went from $5 to mid $2.
Yet liar is all that can be said of the CEO? Have to be more creative than that as preclinicals keep piling up showing the possibilities of a-273.
While the ones with a lot of shares would keep the CEO and board exactly how it is.
Sure one can say that it’ll happen again until it doesn’t. Just as how the pps must go down again because it always does.
He very well could be diluting as we are above $3 , which is the LPC agreement unless I read an earlier post wrong.
It was a question not a smart a$$ remark.
Like it or not about that BIIB testing, you know nothing more than I do about it. Yet, I don’t cling onto it like it’s the ONLY thing that a-273 has going for it.
Something may come of it, something may not.
BP seems to be tucking tail and running when it comes to Alz trials. Maybe they finally figured something out we all have been saying for a long time.
20 years and Billions of dollars and nothing more than a extra month or 2 of a life forgotten.
You think if BP had a-273 in their hands they would have known what to target? Or just send to trial and cross their fingers?
Placed an order for 273 shares. ????
FALSE!!
They added. From 2.1M to 2.7 M
https://fintel.io/so/us/avxl
Including:
Morgan Stanley increasing by 68% 59K to 101K shares
Park West by 28%
2.1M shares to 2.7M shares
Hey but then again, according to some, they are ALL selling.
Not to shabby slowly moving up in insty holdings. Now just about reaching 24%.
Lol great clueless post. ENTIRE post is opinion rather than fact.
Lol earnings?
3 things can happen with this investment.
1. Anavex allows themselves to get bought out WHEN the time comes. Giving up a-273 and batting clean-up, A-371.
2. A-273 doesn’t pan out in all 3 trials and pps drops to pennies.
3. Anavex goes it alone to become the new BP on the block with a-273 in pocket and a-371 on the side waiting for its turn to prove itself.
Of course there are no earnings, that was settled many years ago.
You DO understand that the ride to $14 was a pump by nefarious people right, followed by the dump and attacks by ahh.. that was so long ago and not even worth reliving anymore, so are all the speculative talk.
Im here to see data readout and go from there, no matter how long it takes.
Wow, the sudden 180. Maybe he has no choice but to wait for the new guidance to come out. Does the delays suck? Yes.
How I’ll laugh when things start rolling and the 180 attitude again .
In the mean time, Missling said this to one of the questions.
Christopher Missling
Yes, all of these things we are – we have found something and we have submitted the analysis, the outcome of this to a very – the most reputable scientific meeting this year. And before that, we obviously are bind by the requirement to be silent on that until that will be disclosed exclusively at this conference.
You have the option to leave, no one is forcing you to stay invested, if one is even holding any stock.
I mined crypto in 2013, before mainstream even heard of it. Keeping everything I mined. Fast forward to today, it was a wise strategy.
Everyone has their own exit plan on Avxl. Mine happens to be many times the current pps or bad data from trials. Day to day drops are of no concern to me.
The best attack is Missling isn’t moving fast enough?, please.,,., there are real scam stocks out there, AVXL just happens to be not one of them, yet.
Wow, when did Dr. Missling start to be blamed for everyone’s losses in investing. It’s the investor that decides to stay or go. Don’t believe, leave. I remember Avxl and CBIO was at the same conference last year and about the same pps(under $5). Look at the difference now that CBIO is getting ready to release data. It shows the potential AVXL has when that time comes. Until then, adding little by little at these low prices. At least I have to thank the short and slanderers for that.
Cancer is the reference, but it should also apply for other diseases as well.
What do we do when we have a targeted drug, introduced in a properly selected group of patients, which has an outsized effect on overall survival in a rare or deadly cancer, but where that benefit is seen in a small trial, where we would still need more evidence to fully understand how to best use the drug in clinical practice?
We might want to approve such a product earlier, and require a post-market confirmatory study to validate the finding – similar to an accelerated approval approach.
Am I the only one that read the statement from today where it stated that approval would be given early under certain conditions and data will still need to be gathered AFTER? I'll look for the exact paragraphs. Saw it earlier today but had no time to post.
What make you of the Nov 30 FDA update on the progress of 21 century cures act? Ain't it 10am eastern tomorrow?
Too funny. That 6? That's 6 more than what BP could do in a thousand plus patient trial.....combined.
Then again, misdiagnosis is the counter these days.
I believe he isn't grappling with the data. He knows the design already and just waiting for FDA to give the nod.
Don't believe it? Guess we have a little over a month left before end of year arrives.
Yes, and with safety a non issue, it has a possibility of being one.
Very exciting idea during these manipulative times
How is it that 6 people could be misdiagnosed in a 32 patient trial yet in a 2000-3000 patient trial, not one?
Happen to have anything on misdiagnosed patients and how often they get placed in any Alz trial?
Remind me what that reality is on this great Thanksgiving Day?
So I checked the instys that filed looking if any new ones got added since 11/15. Low and behold, SIG reported on 11/15 that all put, call, and about 260,000 shares were exited during the last quarter. Then on the 20th, it went from all exited to all 3 positions being reduced. So, now we are back to over 10 Million shares held by instys.
How often does that happen?
Read one comment behind. Lt is calling the pr fluff even though it's a pr about being reviewed by other professionals in their respective fields.
Peer review is fluff now? Lol
I think we are all aware of the prestigious people who dropped out of college and created their own empire most college grads would dream of.
DD is good ONLY if it's done correctly. Doing a background, worse, college one on someone that has been in the FDA for over 20 years has NO meaning. You might think it does, but most know what's going on. Nothing but a sideshow trying to gain attention.
Now if you were to do some DD on a-273, I'd be all ears.
Well, I'm sure you'll start seeing the name a lot more in the coming years
Oh no, even IF trials run behind schedule for some unknown reason, I will still be here. Missling and EVERYONE below him is top notch in their respective field
Pharma investing is a tricky thing
"So he does have right information but does not share it to protect from shorts? How many times I have heard this excuse being used on boards"
I never said that. What I did say was that he is keeping data not only from shareholders BUT ALSO the shorts and BP that could very well possibly be waiting on more data.
Thanks for trying to understand a simple paragraph though.
He stated multiple times trials start by end of year. Last time I checked there's still a whole December before the year ends.
Never understand the logic in investing in a company where one doesn't believe in the CEO and board to get things done.
If I ever feel like Missling is lying to ME, I'll quietly exit my position. No need to yell it on a board or seem like a sour investor that lost money.
I'd gladly bring up your conversational banter in exactly 365 days from today just to see where we stand then compared to today.
I know, you were around just as long as I.
He's not only hiding information from company shareholders, he's also hiding info from the short cabal as well as the sharks that are circling the company waiting to aggressively takeover the co. Believe it or not, it does happen.
As long a Missling continues to implement his plan for the company, and data remains positive, time is on our, the longs, side.
Now is not the time to grow impatient just when the "iceburg" is about to set sail.
Then again, everyone has their own opinion.
I suspect you didn't think they were transparent 2 years ago when they pr'd a lot more and even was called a pr scam machine. Damned if they do damned if they don't.
Either way, science WILL put the pps in its correct spot eventually no matter if they communicate with impatient shareholders that don't understand what by end of year means.
Whats the chances of A-273 being designated Regenerative Medicine Advanced Therapy Designation (RMAT)?
Interesting that it states the following:
"The request for RMAT designation must be made either concurrently with submission of an Investigational New Drug application (IND) or as an amendment to an existing IND. We will not grant a RMAT designation if an IND is on hold or is placed on hold during the designation review."
then:
"To be clear, we remain committed to ensuring that patients have access to safe and effective regenerative medicine products as efficiently as possible."
I don't care what the pps right now, things are starting to warm up behind the scenes.