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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.
Being objective here, it is a trial of n=2 WITHOUT a placebo arm.
Would you treat Anavex to the same standard from here on?
I mean for the sake of all Rett patients that is.
Or do you have a double standard in which you grade Anavex`s success much harsher?
If so, then that is pretty cold hearted in my opinion.
The article is great and has hit all the points everyone here have already discussed, and why I stay invested.
This is BlackRocks ETFs exposed to AVXL and their corresponding percentage of exposure.
Criteria per ETF are each different and I find that it doesnt equate to any stamp of approval for success.
Im in the camp of I`ll be leaving when they are joining, what happened to that eye drop company and its 70% institutional ownership?
Absolutely nothing, since they can`t predict what the FDA will do.
Why in my opinion, is better to invest in indications with no or very little available therapies, since the pressure is on the FDA to approve in these areas more aggressively.
BlackRock ETF exposure list to AVXL Total Monetary Allocation=$18,618,208 (after multiplying the total asset to the allocation percentage)
iShares Neuroscience and Healthcare ETF (total asset value 4M)
1.37%
iShares Micro-Cap ETF (total asset value 730M)
0.12%
iShares Biotechnology ETF (total asset value 6,365M)
0.05%
iShares Russell 2000 Growth ETF (total asset value 9,222M)
0.04%
iShares ESG Aware MSCI USA Small-Cap ETF (total asset value 1,231M)
0.04%
iShares U.S. Small-Cap Equity Factor ETF (total asset value 713M)
0.04%
iShares Morningstar Small-Cap Growth ETF (total asset value 406M)
0.03%
iShares Russell 2000 ETF (total asset value 49,977M)
0.02%
iShares Morningstar Small-Cap ETF(total asset value 188M)
0.01 %
iShares Russell 2500 ETF (total asset value 775M)
0.01%
Oh crap I forgot you weren`t on earth during the pandemic.
Which lasted and slowed down the WORLD for at least 2 years.
Oh alright then I'm glad I was able to clarify what you implied, since it wasn't clear.
Fair question, but if results were in, what makes you think the longer we wait the worse they are?
Yes I been told, and you very smart.
Now we keep an eye on the measuring stick to see if is being measured or used to measure.
Yes, I understand, but I wanted YOUR exact measuring stick.
Now I got it, thank you.
No it did not surprise me, but now we have something to measure it against.
I hope is a big room, it will need a lot of head space and not for mine.