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Asking TGA for provisional approval requires the same full data package that the FDA NDA and EMA MAA requires.
So what is the advantage of TGA approval compared to FDA or EMA approval?
I'll be damned. I went back and checked again and it does not show CGI-I as secondary on the first record. I would swear that it did when I looked at it the first time.
The rest of the post still stands.
According to clinicaltrials.gov the first trial description had CGI-I as secondary outcome version 1. The first trial update after that had CGI-I as co-primary. version 2
It stayed co-primary until the September 27 2021 trial update and it was switched back to secondary outcome. That was version #8
From September 27th 21 up onward CGI-I remained in secondary outcomes through the final version #17.
The Sept 27th 21 update showed that the changes were "Outcome Measures, Study Status, Eligibility, Study Description, Contacts/Locations, Study Design and Study Identification"
It was the first update that made what appears to be an error. The changes for that update were listed as "Arms and Interventions, Contacts/Locations and Study Status". Notice that outcome measures was not listed as a change. It appears that the change to CGI-I to primary outcome was an error in the update and that wasn't corrected until the Sept. 27th update. All of the updates between the first on and the Sept 27th update are listed as "study status" or "Contacts/Locations and Study Status" updates.
As for the seizure outcomes information. You assume that it would be disclosed if it was stat significant. The company may not have been analyzing that data at that point, being more concerned with the RSBQ and CGI-I issues.
So you were not quite right about when CGI-I was changed and changed back.
We do not know for certain if Anavex is in discussions with the FDA or has scheduled a meeting with the FDA or if Anavex has had multiple meetings with the FDA.
Missling doesn't release information about FDA meetings in general. He mentions intention to meet and that is it.
It would be nice if he did.
It turns out those are the appropriate words to use in discussing the future.
Only two things are certain, taxes and death. Everything else is a probability.
One of the secondary outcome measures is a seizure diary kept by the caregivers. That constitutes controlled empirical evidence. Whether that is statistically significant has not been disclosed.
From the clinicaltrials.gov website.
So have you. The difference is that what Missling says makes a difference. You, not so much.
You can thank IHub changing the rules for the decrease in civility.
As a mod I can no longer remove the personal attacks that I used to be able to do under the old rules.
Missling said that he was going to discuss the path forward with the regulators. That sounds like continuing to pursue Rett to me.
The FDA is going to tell Anavex what the path forward will be. Until Anavex has that guidance from the FDA it is in a holding pattern vis a vis Rett.
Australia proved the same reimbursement to Anavex that it does for other companies running drug trials in Australia. There was nothing unique about what it did for Anavex.
What Australia did was a reimbursement of a portion of the drug trial costs for running the trial in Australia. It wasn't a grant or up front funding.
Population of AU in 2023 26.6 million people.
Population of the EU is 448 million people. That is close to a 20X larger market for essentially the same amount of effort to obtain approval.
Which market would you pursue first?
Consider this: If the Rett trial had turned out significant Missling would be a hero and Anavex would be off to the races. Alas, the results didn't come back significant.
Those trial design decisions were made a long time ago. In hind sight it has been argued that the trial should have been larger. That may be. At the time the decision was made about the trial size the results from the previous Rett trial made that look like a pretty good choice. The trial got hammered by the joys of random selection. Shit happens. Type II errors occur.
It still remains to be seen how the FDA will react to those trial results. Are we going to say Missling is a hero if the FDA allows the Rett NDA to go forward and say that if the FDA requires an additional trial that Missling is a zero? There is something wrong with that metric.
You missed my point. There is a wider world beyond the FDA which I was referring to, the investment community.
Approval. Legitimacy.
Approval brings in investment and funding. It validates the treatment approach.
Those are more important than the immediate size of the revenue stream. IMHO.
Why wouldn't DCVax make it through ab FDA Adcom?
Getting DCVax approved in the UK establishes the treatment as legit and creates a revenue stream that NWBO sorely needs. If the UK is the fastest place for approval then that is where NWBO should go.
From the Anavex web site.
Contact Us
630 5th Avenue, 20th floor
New York, NY
10111 USA
And you have no idea how many funds other than index funds that Blackrock and the other big money managers have.
Yes, the majority of the funds AVXL holdings are in index funds. At the same time it is the discretionary funds that are adding AVXL shares.
One thing we can agree on is that Missling does not provide a lot of clear guidance.
I suppose that is a response to that frivolous lawsuit years ago. The large short position may also play a part. Given the usual response to any good news from the company is an attack and a drop in share price, Missling may have decided no news is good news. It is frustrating for us shareholders.
Ultimately trial results and approvals are all that count.
I reread your post. My take on what the company meant is exactly what the statement says, it has no control over the process. I suggest you may be reading too much into that statement.
The "will be published" is a pretty definitive statement.
The company has no control over the publication date of a paper.
The editors of the journal can sit on the paper for a theme issue for example. The paper can be bumped for another hotter topic paper that comes to the publisher.
In general it is my understanding that the company will be notified when a paper is to be published in the up coming issue but that is it. Doc has experience with this process and can give us a more definitive answer.
Peer review takes as long as it takes. I have seen some peer reviewed papers that were published in 2 months and some that took 2 years.
All that the company can say is that it has a paper in the process. How long that process takes is out of the company's hands.
We are dropping because the Rett trial did not come out as expected. There is no significant news expected in the near to medium term, as a result there is little buying pressure. So the share price drops. Of course the fact that the overall market is taking a beating at this same time is a contributing factor.
If you find this scary then you need to reconsider why you invested in Anavex. Is ti fun? Is it enjoyable? Is it desirable? No to all of those.
Is this being invested in a biotech based on ultimate outcome? Yes.
I suggest Growaset.
If that is the case then the LOI was filed in November. That starts the 7 month clock to the submission of the MAA.
What part of a calendar do you not understand?
When was the first mention of the EMA by Anavex? Do the math.
I have no information on the LOI status.
SHMP up 89% as I type on vol of 20.45 MM shares.
Has it been 7 months already?
16.6 million shares traded today and the SP is up 58%. Something is up.
This is an article that may be getting closer to root causes of many CNS diseases including AD.
https://phys.org/news/2024-02-undruggable-proteins-approach-neurodegenerative-diseases.html
I didn't see any non approved drugs mentioned in that article. So not seeing Anavex is not surprising.
I suspect we won't see much mention of Anavex in the main stream press until there is at least a NDA filed.
Very interesting article. It sets the stage for 2-73 to be used as a prophylactic if it can get approval.
Interesting that the numbers are so low about those going on to get clinical symptoms of AD after this test diagnosis. 23%.
That leads to the question of how many needed to treat to prevent a case. We have seen with the statins that a very high number of people treated to prevent one death and that has been found acceptable.
The other thing that jumps out at me from this article is that the causes of AD are still not really known. This looks to me to still be searching for earlier symptoms and not finding causes. Given the low progression rate, assuming that continues to hold, it becomes clearer that Tau and plaques are late stage factors and not root causes. In a way this should help drive a nail into the coffin of Beta Amyloid plaque and Tau as targets for treatment and prevention.
So how's that 11 millions shares workin' out for ya?
We have been through this false argument multiple times
The bulk of the shares owned are in various index funds where the fund manager has little choice about which companies and how many shares to own.
A significant number of shares are in various discretionary funds where the fund manager is able to choose which stocks are included in the fund. It is those discretionary funds that are adding shares.
Many of the index funds are market cap weighted which means when the funds rebalance a stock with the share price drop should result in the fund selling shares.
What we are seeing is the total number of shares owned by the large money manager funds is increasing.
If you read through the list of outcome measures it looks like most of those will be taken care of in 4 visits. There will be a follow up visit some time after the trial is complete.
So it doesn't look like that trial will be that onerous for the patients and caregivers.
I think you exaggerate the difficulty just because there are a lot of measures.
I suggest you take your own advice.
That is not what he said. He said they "could" be so good that the FDA" may" immediately approve Anavex 3-71 directly from this Phase 2 trial.
Which is clearly a guess. Just like your guesses of "We could get a big upside surprise coming out of left field but it sure doesn’t feel that way.
He uses the caveats that you do. He just does so in a positive direction while you go the other direction.
Not exactly a big problem. Be well.
You might want to spend a little time with Google before you make your posts about what the FDA does and doesn't do.
What is that saying? Something about the pot calling the kettle...
The phrase is " will be for naught". But aside from that you are correct. Like any other company it has to achieve a successful product to achieve a beneficial outcome.
I think your use of the word dilutive is misapplied.
Anavex is a pre revenue company. Its only source of funding is shares sales. That is what the capital market is for.
For me the term dilutive means that there is no value returned for the shares sold. If there is value obtained for the shares being sold then I don't see that as dilutive, I see that as an appropriate use of company assets and shareholders money.
Currently the shares sold are being used to develop drugs that when approved will generate significant shareholder value.
If the shares being sold increase the overall value of the company is that dilutive or is that increasing the value of the shares?
Right now the share price isn't very good. If it stays that way long into the future it will be because the company has failed not because shares were sold increasing the OS. If the company gets 2-73 approved the share price will be significantly higher than any decrease due to the impact of selling the shares that got the company to the point of generating revenues.