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Nice shift in the discussion to a personal attack. Lame.
I also looked for it and didn't see it listed on clinicaltrials.gov.
My source was the Anavex PR.
It is my understanding that large portions of NDAs are frequently contracted out to companies that specialize is preparing NDAs and MAAs.
I would expect Anavex to so the same. Maybe they will do it all in house. I don't know.
Sections of the applications such as the drug history, the manufacturing, trial results, MOA etc. will be the same. There has been an effort to "harmonize" the process between the EU and the US.
If that is true WTF are you still here?
Remember that the OLE allows the placebo group to take the drug in the OLE.
So the placebo group would need to show improvement over the previous placebo response to be a positive outcome.
I disagree with your statement about not being able to work on the FDA and EMA submission simultaneously. While there a some difference and extra requirements for the EMA, the bulk of the submissions should be identical or very similar.
The EMA submission is not due for many months after the LOI is filed. Even if you assume the LOI was filed some time ago there should still be 4 or 5 months to prepare the MAA submission.
Hasn't Missling stated that he is waiting on the AD OLE trial to be completed?
The plan will be decided by the FDA when they give Anavex guidance. Whether Anavex is going to share that with us shareholders is another question. When the FDA gives that guidance is also another question. There is a 48 week Pediatric OLE in progress with a 91% participation rate. That OLE should complete at the end of April.
I wonder if Anavex is waiting on that to conclude before approaching the FDA on Rett guidance.
What makes you think that a peer reviewed article is necessary for a discussion with the FDA?
Thanks. I was unaware of that resource. I appreciate the education.
Do I need to sign in as a Financial Professional, or will individual investor allow me to get that spreadsheet?
Doc, Where did you find that State street data? Thanks.
You beat that drum all the time. You might as well get used to the fact that Missling isn't going to go. As another poster pointed out, one approval and he becomes a hero. Two approvals and he becomes a super star. A couple of NDAs get filed and he is good for another year or more.
No approvals and he gets booted.
I think that comma was supposed to be a decimal point.
Why should we buy your hype?
NWBO's submission is much larger than the average. I suspect due to the very long time frame of their trials and the new approach they are taking to treating cancer.
My research suggests that the average NDA is closer to 100K pages. Still a substantial undertaking.
How soon the trial results take to appear is going to be determined by how long it takes to recruit the 40 subjects.
They have to be illicit drug free and willing to go into in patient facility for the duration of the trial among other things. Many schizophrenia sufferers self medicate.
It may take a while to get the 40 subjects.
I suppose that if they bring the trial in under budget you'd complain about that too.
Thanks for posting that article. Heavy on the mabs.
I did learn a new unit of measure, the centiloid.
Not sure where you came up with the 155M share number.
The OS slightly over 82M shares. 31.5% held by institutions. About 25.8M shares.
You seem to have ignored the rest of my post.
I appreciate a balanced view myself and your numbers are about right I think.
Credibility ascribed to any one or group of posters is a personal decision.
I find some value in both extreme groups and more value in the few balanced posters. It is what it is.
The enquiring mind will have to wait for the FDA to give the answer to that question. Till then it is an unknown.
Your picture seems to start at 16:00:07 which would miss the trade.
Nasdaq shows the vol occurring between 16:00:00 and 16:00:01.
There is no shortage of posters willing to point out the good and the bad. You seem to be complaining that they are not the same person. So what?
Anybody that reads most of the board, aside from getting turned off by the personal attacks and dick measuring contests, gets to see a complete picture of the possibilities both good and bad.
I just went back and looked at the chart using MEDVED. The vol graph shows a spike at 16:00 but the scale shows it to be about 350K shares. I think that is because the size of the trade is SO large compared to all the other trade sizes that it doesn't handle the scale properly.
If I put the mouse on the closing trade it brings up a window with the correct volume and price data.
Nothing wrong with pointing out "flaws, inconsistencies, and missteps by management...".
Doing so and casting everything in the worst possible light without mentioning the positives and the possibilities of success is reason to doubt one's sincerity.
Interesting. Wonder why that is. Perhaps the chart is coming out of the cache on you computer. That happens. You might try clearing the cache and see if that still persists.
Look at the Anavex chart beside the message. You will see a single tall red line on the volume scale.
The MOC trade posted at 16:00:00 according to my T&S was 4,515,588.
You know far more than I as to how that number comes about.
Because there were 6.5 million shares sold?
The real question is where did those shares come from? Were there a lot of shorts? Did some large shareholder dump a huge position?
the answer to those questions will tell you a lot more about the sp action than just the large volume.
I read the complaint and it lays out the arguments that showed up on the board and little else. If you found those compelling OK.
I found them pretty weak myself.
The opinion of the Judge is the one that counts.
There are a few steps to be taken before discovery occurs. The plaintiff has to survive the motion to dismiss for example.
Have it your way. I have made my point.
Since you are using the share price as your metric. If the FDA accepts the pediatric Rett trial and approves the NDA the share price will undoubtedly rise significantly. Does that then change the trial from a failure to a success?
Actually there is something nuanced about this discussion.
Failing to to meet endpoints is fine. Say that. "The trial failed to meet endpoints".
It has yet to be determined if the overall trial failed. That will determined by the FDA.
If the FDA says an additional trial is required then I will agree that the trial failed.
There is a distinction between those two.
Turns out the situation may not be as black and white as you suggest.
Frequently these lawsuits are filed and never intended to go to trial. The law firm wants to settle and collect a fee. The companies choose to settle because it is cheaper than going to court. It is a form of legal extortion. Some cases are obviously real, many others legal extortion.
They hadn't when I made my post. Things change. I suspect you knew that but couldn't pass up a chance to be a .....
The ambulance chasers HAVEN'T brought a class action suit. Those are ads looking for a lead plaintiff for such a suit i.e. they are fishing.
What makes you think that anyone actually does listen to those predictions? So far the only people that seem to react to them are the ones that bitch about them.
This sentence tells the story.
What part of "potentially" is difficult for you?
Trials are sometimes stopped because the results are so good that it is considered unethical to continue and the NDA is filed.
It appears the the adult Rett trial results were good but not good enough to be pivotal. Or, more likely, the FDA wanted to see the pediatric trial and do one NDA for all age groups.
That trial was mandated by the FDA before Anavex could do the pediatric trial.
The Adult Rett trial was 33 subjects. That is likely too small for an approval.