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That is a personal choice.
Missling explained why they started with the EMA. The EMA process takes longer than the FDA.
It takes 7 months after the LOI before the MAA application has to be filed, so they get the process started while they are still writing the MAA/NDA package.
I may not be "in the know" enough to satisfy your requirements, but here it goes.
I think not on the filing of the AD NDA for the following reasons.
The company was not focused on preparing the NDA for AD when the Rett results came out. It was focused on Rett. If there was an NDA in preparation it would heave been the Rett NDA.
NDA preparation is a big undertaking that would take longer than the time since the Rett results unless they were already working on it.
I suspect the company is waiting for Rett guidance from the FDA before proceeding with any NDA. There is still an outside chance that the FDA will suggest going ahead with a Rett NDA.
Any AD filing preparation is likely to be focused on the EMA MAA. Yes there is commonality between the two. The company chose to announce the EMA process start which suggests that an NDA filing, which is more significant that starting the EMA process, would also be announced.
I think you are incorrect in this statement. "! Distribution and Sales are part of submission..."
I didn't see anything about distribution and sales in either the EMA or FDA submission package sections lists.
There are requirements for labeling, packaging, promotional materials but nothing I could see about distribution or sales.
If I have missed those please give me a link so I can correct my error.
Just a bit of hyperbole.
Not sure how that related to Anavex but I will say that was very impressive dancing and music. Thanks.
You do realize that Bayesian inference method starts with an initial probability and then modifies that probability based on subsequent information.
To be more specific it uses initial probability distribution which is then modified by subsequent information resulting in a new probability distribution.
So what is your initial probability to which you are going to apply your Bayesian approach?
Thanks but that doesn't answer my question.
Of course. " I want to see Anavex move past Day-1 before having a view on chances of approval."
Every track bettor would like to place his bets as they round the club house turn.
What percentage of MAA applications are withdrawn at clock stop 1 and clock stop 2 ?
It can take up to 60 days to schedule a meeting with the FDA. That is to set a schedule. That meeting date can be another 60 days after the agreement to schedule.
Anavex well gather all the information they have and figure out how they want to present it, only then will they request a meeting date with the FDA.
I realize English is not your first language but that post is impossible to figure out.
The term biomarker is used on this board as if there was only one type of biomarker and in fact there are 7 different types of biomarkers.
Add to the list surrogate endpoint which is a different beast although it is frequently referred to as a biomarker.
One of the key differences is that a surrogate endpoint is deemed acceptable on a case by case basis.
There is a very specific procedure the FDA has for getting biomarkers accepted as surrogate endpoints. That is, those used in accelerated applications.
If the Ab ratio is not accepted an surrogate endpoint the the trial has to be evaluated on the pre defined endpoint.
The improved Ab ratio will be considered as supporting evidence but not in place of the defined endpoints.
It's not likely that Avatar had enough subject to support an NDA so your logic is flawed.
Thanks for that important and insightful analysis of the presentation.
I show vol 1,010,291 at 4:09 EST.
-3.32% for the day. Sigh.
One can assume whatever one likes.
Missling historically has not disclosed FDA meetings directly. One the few occasions that he has disclosed the results of FDA meetings it has been long after the fact and usually when a significant controversy has arisen.
If "the FDA told Missling to take a hike" means that it would not accept a filing that would clearly be a material event and would be PR'd.
Anavex has its share of OCD followers. Some buy and hold shares and others dabble in shares.
Troll.
To me that suggests that the shorts have been borrowing shares and selling them which should keep the share price down.
That is not a positive in my book.
The regulators haven't had a chance to mess with Anavex. Anavex has yet to file an NDA or MAA.
So far what "guidance" the FDA has given Anavex , that we know about, has not been obstructive.
I would hope that sections of the MAA/NDA were already written.
Given the ongoing talks with the EMA CHMP I would guess that the actual trial data section is waiting on the outcome of those talks.
The fact that Ern lives in Australia might make that a bit more difficult.
And ERN's current status is not particularly relevant at this point. Without knowing his complete medical history his current status would be less informative than you might think with one exception.
If it bothers you, go look for it.
I don't remember which poster reached out to the TV station. It was posted on the board.
Talon, thanks for bringing that to the board. I'm about 1/3 through the list of FDA decisions. This certainly give a good view of the volume of work the FDA does as well as the number of applications that result in a Complete Response Letter. It is surprising how many CRLs are for manufacturing inspection failures.
There aren't anymore videos because the TV station that made that video didn't do any more follow up stories on 2-73. In fact, they have been contacted about doing another story and replied that they won't until 2-73 gets on the market.
Actually there were several people in that TV story that showed remarkable recovery of abilities. It is RWE of 2-73 effects in some people.
Does that move those RWE out of the anecdotal category? Probably not. Does it demonstrate that there appear to be "super responders" ? It would seem so.
Lol. Negative Nelly.
In fact that regulatory outcome is what will decide the fate of the company. The only choice we have is hold, sell, or trade.
I do both hold and trade. Your vociferous posts provide little value in making those stock decisions.
So for the hold portion of my portfolio "simply invest sit back and await on some regulatory outcome." is in fact what I choose to do.
For the much smaller portion of my Anavex portfolio I trade based on news and price patterns. I haven't noticed any information in any of your posts that aids in that.
And your point is what?
And I might not, which is the point. The future will be decided by the agencies no matter what your or my predictions are.
I think I'll let the FDA and the EMA decide what are the indisputable facts.
It is a P2 trial that among other things is attempting to establish the appropriate dose. It has 5 arms to it with a total of 40 subjects, there won't be nearly enough subjects in each arm to justify approval or allow reasonable statistics. It has approximately 39 Primary outcomes and 8 secondary outcomes.
This is a P2 trial that will provide the data to design a P3 trial.
It's P2 trial. A P3 trial would be larger.
Kinda like your posts. A BIG ZERO !!
Wow George you go one right. Vol 1,572,982 $5.33
Maybe. My landline was converted to a digital land line so when I lose power the land line dies too.
Dial up can be your friend. A very slow friend but a friend.