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Gaps did fill Monday. The gap at $6.70 from Friday11/14 and the gap at $6.25 from Monday 11/20.
Isn't getting agencies to say yes the point? The more the merrier.
The numbers we have been given so far are sufficient to move on to clinical efficacy as the critical value as I see it.
Rett will be the first thing that the FDA sees for approval. My opinion is that Rett looks very good for approval. It's the FDA's opinion that counts.
The word conclusive is probably not a good choice.
A better description is the results are less likely due to chance. P value only partially describes the strength of the results. The size of the trial also is an important variable to consider.
The most important consideration is, are the results clinically meaningful? If the results are clinically meaningful then as long as the P value meets the commonly acceptable threshold for significance, the P value is not particularly important. The P value becomes something akin to a go / no go switch. If it is a go then the strength of the clinical response is the important consideration. If the P value is a no go then it doesn't matter about the clinical response.
It is quite possible to have a very low P value like P <0.01 and still not have a clinically meaningful response.
My guess is that AU is next. It is beginning to look like Missling is trying to arrange for AD to be approved in multiple places at about the same time by timing the approval process in the different jurisdictions. We shall if that is the plan.
What makes you think that whatever George posts makes a lick of difference to the share price?
If you have ever had to do a Gant chart for a project with a specified end date that is what you would do.
I can only sticky one message.
Sounds like you have no idea how the EMA MAA process works.
Anavex can't submit the application for 7 months after the meeting that just took place. That 7 months is what it takes for the EMA to select SMEs and set up its end of the process to evaluate the MAA when submitted.
Yeah... Count on that.
Somebody needs to root for the share price to fall...to fill the gap of course.
That makes homeostasis all the more attractive.
Redshoulder was right.
What do you expect? Anavex is a developmental bio tech with no approved drugs, no revenue stream, and no NDAs filed anywhere.
That combo does not attract top tier analysts.
Once an NDA or MAA is filed higher quality analysts will start paying attention.
Don't piss on my leg and tell me it's raining.
There was nothing "disastrous" about that CC yesterday.
Good point. I'm still getting over the flu so part time in la la land. I was thinking of my Jan 19 2024 options. My bad.
4 weeks left.
The CC was pretty much like every other CC. Missling stuck to the PR. There was very little new information.
There was no bad news.
There was a maybe Rett TLD might be later than expected.
All the hype and high expectations were created on the board. The company didn't create those.
There are still 7 weeks left in the year. We will see what additional information comes out between now and then.
I just checked the 10K there were no subsequent events.
Oh wait..... Those shares are held by mindless index funds and mom and pop biotech investors. No serious biotech investors own Anavex we are told.
So it would seem that the market i.e. those who actually buy shares out of choice is very small for Anavex.
More likely, there are no big brokerage houses pushing Anavex for whatever reason so Anavex really is a small developmental biotech in a very high risk space that most investors know little to nothing about, nor should they.
Thanks for your take on that.
The trial ended June 30 2023. So that final safety visit would have been August 1 or thereabouts for a 30 day visit. That leaves about 4 months till current day.
Missling is suggesting that there is data that has not yet come from the CRO and that delay is due to "an additional safety visit". That suggests one later than the one you describe as the normal 15 to 30 day visit.
I guess we will find out sooner or later.
What are you complaining about?
That text came from the SA transcript.
My point was that the SAE, if there was one, has to be classified. That is a process. Until that process is completed they can't release the TLD.
You and I are saying very much the same thing.
He rewording of this reply suggests to me that he knows when it will be published.
Given that Missling said the OLE data was going to be part of the NDA package, I'd guess that was an outcome from FDA meetings. OLE data can be supportive but as I understand it, is not usually important enough to hold up filing and NDA
You may not like his choice but MIssling has said Rett FIRST.
So AD approvals are scheduled around that, at least in the US. Given the time line for EMA approval US AD is still likely to be first.
Interesting that Missling said multiple meeting with the EMA people not just the one. He PRs just the one that had hard decision/result.
I expect the same for FDA meetings.
If there was an SAE it has to be classified as to whether it is drug related or it is unrelated.
You're right, that wouldn't delay number crunching. It would delay publishing TLD until that issue is settled and can be reported in the TLD.
He said "preparing to initiate" on all the upcoming trials.
I'm taking that to mean setting up CRO's and the like, with "initiate" meaning starting patient screening.
That may be an optimistic view of what he said.
Also I heard that the AD OLE data is going to be part of the FDA submission so the OLE has to complete prior to submission.
As I understood his answer, the EMA got to see all the AD data when it made its recommendation. Is that what you heard?
He didn't really answer about AU.
As for the FDA and AD, Rett is first. If there is a delay on Rett that pushes AD back in the US.
Apparently operating the speaker volume control was a significant challenge.
That assumes that Missling is following the standard path.
There is little evidence for that.
History has shown that Anavex PRs generally result in a share price drop. No need to feed that dragon.
Welcome to the posting side of the board.
Anavex has been laying the foundation for quite a while.
The easy answer to that is, there is no evidence that 2-73 has failed. In fact, quite the opposite.
I quoted a study that looked at the data. I don't have their data.
Filing an FDA NDA is not material because the outcome is uncertain.
In a bit of research confirmed that 98% of companies do disclose filing an NDA. That research also disclosed that the time between the filing and the disclosure could be a few days to two months or more after the filing.
Data from 2010 thru 2016.
Sorry that my thinking doesn't pass your tests. I'll work on that.
I doubt that you are correct on that. My reasoning is that a similar meeting for Rett should have already been held and we have heard nothing about it. Maybe a similar meeting with the FDA on AD has been held or is scheduled. Again we have heard nothing about such meetings.
We shall see. It doesn't really matter either way. Things will unfold as they will no matter how we speculate.