Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Avxl hasn't tanked. It hasn't soared as expected.
Avxl is in a holding pattern until there is clear results from an agency, either pass or fail.
It remains to be seen what Missling's strategy is moving forward. I suspect he is waiting for guidance from the FDA on Rett to decide what to do vis a vis AD. Obviously Anavex has started the process with the EGA. The timing on that process doesn't preclude Rett obtaining a voucher.
If the FDA says it wants an new Rett trial my guess is that Missling will go full out on AD.
In the mean time the company is moving ahead on schizophrenia and hopefully announcing other trials soon.
As a friend of mine pointed out one time, it is important not to make a decision until it is necessary to make that decision.
The peer review paper is largely out of their control. The process can take months or a year. Once the paper is accepted for publishing it is up to the publisher as to when it will be published. The publisher can hold the paper for a theme edition for example or choose to get in the next edition as important information.
So I suggest decoupling the paper from the rest of the events as you think about the company. Yes having a paper published on Monday with great results would be most desirable. But as we have seen with the Rett results, the paper may not be the very positive outcome we hope for.
Overall the fate of the company is determined by approval for an indication. That approval is determined by the trial results and the agencies opinion on those results.
Basically we investors are along for the ride. The choices are simple. Stay or go.
Ok. After drawing the line in the sand and it is crossed then what?
It's probably more accurate to say that most people on this board regret that this board is treated as an info war.
There is a small group that relish the info war much to the annoyance of the rest of us.
Alas, they were, along with other items that didn't happen.
NOW you tell me.
My wife bought a grumpy cat mug that says "Good Morning.... No such thing."
Indeed lots of options to burn and many of mine got burned today. OUCH! 💥
No. Means no.
Yes I did feel the need to point out the assumption you made in your post.
Of course there is a possibility that there will be questions that arise at the scheduled clock stops, just as there is a possibility that there will be none.
How big an impact those questions will have, if any, on the total timeline is an unknown.
So based on your logic every company in business is above board and never does less than an A-Plus job.
Got it.
You do realize that those clock stops are not mandatory right?
The clock only stops if the MAA has questions that it wants to be addressed.
Mrplmr, your posts are a one trick pony.
The presentation is available from the Anavex website. https://www.anavex.com/investor-material Listed at the top of webcasts.
Perhaps that is not a corporate presentation but just a J.P.P Morgan presentation.
Either way, the link is available from the Anavex website.
He types better than he speaks. WTF?
Companies typically hire specialist firms to do most of the NDA. That would be supervised by the excellent former FDA staff that Missling has hired.
For example. https://www.thefdagroup.com/blog/505b2
Application fee for orphan drugs is waived. So no charge for Rett. AD will have to pay.
In fairness to the FDA. You have to tell the FDA what the meeting will be about and provide the relevant material in advance so the right people can be there and be familiar with the materials presented.
In most cases the FDA will schedule a Type B meeting within 60 days of the request.
Standard MOC trade.
My T&S data doesn't show that. At 15:58:17 there was a total of 38,021 shares traded in that second. That would be a $226,985 trade. Maybe that was supposed to be the Dollar amount.
At 15:59:31 there was a 45,450 share trade @$6.00.
If you look at the NASDAQ site trade log you won't see a single trade of that size, but a large number of smaller trades which apparently are aggregated into a single second and that is the T&S data I get from TDA.
The EMA timelines have been posted several times. That is the EMA procedure. Why it takes the EMA that long before they are WILLING TO ACCEPT an MAA is up to them. Their procedure says during that 7 months they are getting the rapporteurs selected and there are discussions that go on during that period.
https://learning.eupati.eu/mod/book/view.php?id=893&chapterid=822
Depends on the deal I'd guess.
Given they way good news is received for Anavex there is no telling. I'd think getting $1billion up front might just overcome that usual reaction.
The fact that all of the market is red has nothing to do with AVXL being red, Right?
Thank you Dave. No wonder I couldn't find it.
Can someone tell me what the third emoji at the bottom of this post is? I can not find it on the emoji menus.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173634047
I have yet to see an explanation as to how Anavex can shorten the 7 month period between the letter of intent and the actual MAA filing.
I don't think that is correct. Sale and distribution plans don't seem to be part of the module list.
It's a safe bet that almost all of the BP are "interested" in Anavex once it has an approved drug. Especially if the approval is for AD.
So what?
Anavex doesn't have that approval yet. Any interest in Anavex by BP at this point is casual not serious.
There are two separate things being discussed here.
One thing is an evaluation of 2-73 on its merits and ascribing a probability of a successful MAA application. That evaluation includes considering the safety record of the drug, the low bar of the SOC, and the trial data. That probability is determined by whoever is doing the evaluation.
The other thing is the probability of the Anavex MAA being approved based on that 85% overall approval rate for an accepted MAA applications.
Those are very different ways of evaluating the situation.
You have still not grasped the point. The point I am trying (unsuccessfully) to make is narrow point.
Yes it is better to be a member of the 85% group than in a one percent group. That was not the point.
I give up.
Let me see if I can make it clear what I was trying to point out. First I agree with what you are saying. It is better to be in the group making application than not. That is pretty obvious. I think that Anavex has a pretty strong case for approval. I make that judgement based on the trial data, the current SOC. Some agree with that, others do not.
Bio pointed out that ultimately Anavex will succeed or fail in its application. That is a binary event. Is it a 50% chance when viewed that way? Of course not. Other factors are involved like the safety of the drug, the efficacy, soc etc.
My point is that based ONLY on the 85% success rate that doesn't tell you which of the applications will be in the 85% or the 15%. Group statistics have little predictive power for a single member of the group.
We know that a fair coin will be heads 50% of the time and tails 50% of the time. That doesn't tell you what the next coin flip will be. Even if the coin was weighted so that it was heads 85% of the time and 15% of the time it is tails, that still doesn't tell you what the next coin flip will be.
I'm pretty sure you're right.
What you are missing is the 85% stat applies to a group. If there are 20 applications submitted 17 will be approved and 3 will be rejected.
That stat doesn't tell which ones of the 20 will be rejected. The 3 that were rejected had an 85% chance of approval and still got rejected.
Where did you get the idea that I am or was a lawyer?
And that was them and I was talking about Anavex. We already know that Anavex doesn't get the love we think it should.
My point was that once there is an approval people will have to sit up and take notice. Right now Anavex is not taken very seriously. You can use whatever reasons you want to explain why that is the case.
Seems to me that Missling was describing how the market values drugs with some similarities to 2-73. Not an immediate value but rather an ultimate value.
It will take an approval for an indication to realize that valuation. Once there is an approval that buyout indicates what 2-73 may be worth. Probably setting a floor value since 2-73 has a real possibility of additional indications.
IMHO
Based on the wording of his previous comments where he started to say published on the date of and then changed his wording, I think he has been told when the paper will be published. He is not saying when that will be. I don't know if that is a publisher restriction or he just doesn't want to communicate that date and let it be a surprise.
Missling will continue to raise cash as needed via the same mechanism as used previously.
More likely they have been doing the ground work for several of the trials and that is already part of the current expenditures.
Setting up the trial documents, signing up testing sites, initiating site training are no high Dollar items compared to doing the patient screening and the genetic lab work.