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You said generation, I said generation.
Apparently, the shoe was properly sized.
xoxo
Your opinion holds water in its original source, the rest are ASSumptions.
Pompousness/Cockiness/Condescension not foreign concepts of older generations?
Also why we are in such financial shit storm.
GL!
Impressive Leo, only you possess the ability to conclude people's comprehension from their emoji use.
Kudos!
Another example of hindsight 20/20:
Thank you, any more?
So, hindsight is 20/20.
Funny how you never mentioned these potential issues before lol.
I love these hypotheticals.
I`ll play along, what would have happened to share price back then when we announce a change in N? In the middle of the trial.
Specially since changing this N does not guarantee WGT.
After the fact, everyone is a genius.
AF in the past, has shown not to care about peer reviewed or not.
NWBO released a Jama oncology peer reviewed paper, and he claimed that all the doctors in the Jama Oncology paper although well intended, were wrong.
So, if that is his opinion in the light of facts, he can state it without consequences.
In my opinion he most likely does the same to AVXL no matter what the data says.
Pretty odd immunity journalists, from spreading such harmful opinions as facts......
Looking at his logic I think he forgot that water only boils at 100c at sea level.
or did he? lol
Conditions matter, if it flew over.
As Boi perfectly explains.
I hear you, just trying to figure the significance of it or why it matters in the grand scheme of things.
Mistake? if so does it matter? What are we trying to paint here, all I see is an ink blob.
Kind sir (using it loosely here wink wink), pretty sure I missed the discussion and importance of such update...
care to clarify or direct to the thread?
Nice, definitely SMART to have contingencies and parallel development.
Not sure how it matters going forward or making decisions going forward.
It would be a speculation that will give you a signal, no one can verify, hence useless to entertain.
You missed the entire intent of the post.
Poster claims his odds are < 50% for approval with what we currently have.
I exclaim that is good to see odds that go that high, and I personally will just leave mine at 50% with what we currently have with potential new findings.
You are correct in that I can relate more to the WGT camp over the pompous FUD camp.
You are incorrect in that I have ever held any 100% probability in anything other than death, and pompousness from some.
Is encouraging to see you still have memory problems, the 2-73 market for memory problems is alive and well, and still pompous enough to throw a weak attempt at distorting my views.
Yea, so far not so optimal.
But is a marathon, and I don't think the race is over, do you?
I think not.
The camera acts as a signal damper for any healthy human response, imagine a Rett girl?
I completely understand your point that if the overall signal was dampened, the over all volume lowered if thinking music, is hard to differentiate between any notes IF THERE ARE ANY THERE.
Fair response except, being a half full kind of guy, I would exclaim:
AS LARGE AS 50%
Not sure you answered my question, the FDA with what is known today about Rett disease and our trial, would prefer to avoid a Type 1 or a Type 2 error or both.
As per it being a fail vs success is subjective to whether is approved or not with what we currently have.
I hear you the trial FAILED to meet its end points with (stat sig at 0.05).
But to me a FAIL is needing another trial or not getting approved on this trial after deep data dive.
But that is my objection, and only time will tell.
I think you forgot about the things you dont know you dont know and can't control for.
ALL good.
If you were the FDA looking at our Rett data, which would be a worse error to make while analyzing a very safe and well tolerated drug which shows RWE of improvements, Type 1 error or Type 2 error?
In my opinion with what we have so far, safety in an indication with unmet needs, they will be ok with a type 1 over a type 2 IN THIS CASE.
We shall see, I don't think the fat lady has sung yet on Rett.
Just a friendly reminder of the "Approval BAR" in these indications and how low it is.
You are talking to the newest "I'm a new/old but quite investor that is fed up with insert here......."
Beware!
Just on these three alone we check all boxes.
Is that how it works? 4 million sold?
This is top line data, that will come later.
Yes they can still file, Rett is a rare disease.
The FDA has approved drugs before which have failed stat significance in endpoints in rare diseases.
Not saying that will happen here, but it is possible.
Our safety profile, in combination with some efficacy may allow this.
But I guess we need to understand the data from the trial first.
How bad was placebo vs dosed arm in disease level, is what I'm most interested in.
The questionnaire bias, is what it is, is nothing new in these types of designs.
I wonder one thing; did we see these expressions in PDD and AD P2b/3? If so this is YUGGGGEE!
If not les huge, but still very interesting and good to see.
We just got a PR, but the link on twitter is broken shrug.
This one works: https://www.anavex.com/post/anavex-announces-first-entire-clinical-gene-pathway-data-of-anavex-2-73-from-avatar-study-in-patient
Anavex Announces First Entire Clinical Gene Pathway Data of ANAVEX®2-73 from AVATAR Study in Patients with #RettSyndromehttps://t.co/Q6eGm22156#anavex #biopharma #neuroscience #precisionmedicine pic.twitter.com/4Ny93QZbJp
— Anavex Life Sciences (@AnavexLifeSci) December 20, 2023
Hey can someone tell Adam about to the criteria needed to be met for the CHMP agreeing to a MAA submission.
Maybe you can Investor?
For a neurodegenerative drug to apply for UMA, it needs to meet various stringent requirements set by the European Medicines Agency (EMA).
Anyone would like to list these requirements? Investor, is your hand raised?
NO this is what YOU did!
So you are saying the market assessed yesterdays news today? lmao
Ok, speaking of the market did you notice how XBI was red today?
The shorts will protect their position, until they cant no more.
Better pompous than lucky would fit best.
Leave him alone, he is having a rough Monday.
Exacto!
Why are you trying so hard to discount todays positive news?
So now you are into reading between the lines and dot connecting? LMAO
Or a lot less IF its an indication in that has virtually no SAFE and effective treatments.
Great reminder and probably why EMA first for AD since our voucher is with the FDA.
The path of least resistance it seems.
$$$$$ kudos I agree with this strategy and would not discount a similar PR for FDA in upcoming weeks. .
Better question is what the difference between is the top 20 and the bottom thousands.
Comparing the 1st to the 20th is laughable when the sample is of thousands.
Come on you are a SMART guy, us a better brush.
I would rather, the shorts keep shorting all the way up.
Remember the stock market is a zero-sum game.
The more they short, the more money we make on every squeeze.
I wouldn't want them to leave the casino in a death bed, but just beat up enough for them to come back after they recuperate.
Sorta speak.