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Really? When did the company report that number?
Doesn't matter where the Odds Ratio ranks in the SAP, if such a ranking exists. Meeting trial criteria is a binary event. The trial meets the criteria or it doesn't. If there are multiple ways to meet trial criteria, it doesn't matter which one the trial meets.
By way of analogy, you can win a football game with nothing but field goals. What matters is that you have one more point than the other team.
Hmmm. The key phrase is "Notify EMA of the intended submission date (letter of intent)"
The letter of intent starts the 7 months clock.
Submission of the eligibility request can occur 18 to 7 months before MAA submission.
I went back and looked at the PR and it talks about approval for Centralized Marketing application.
I can't find anything specific about a letter of intent in the PR or the CC.
Bottom line is you are probably correct.
Why? Because you left off the next slide that shows the Pre-submission time line which includes the steps I listed. The necessary steps.
Can I remind you that submitting an eligibility request for centralized procedure is a necessary first step in the MAA approval process. Next step is the letter of intent to submit an application, a necessary second step. Once that is approved a seven month clock starts BEFORE ANAVEX CAN SUBMIT an MAA. The seven month clock has started.
Anavex is several steps into the MAA process, each of which is a necessary step in the process.
Personally I will be very happy when the company gives us more to talk about and the board can quit with the ego wars and the discussion of other poster's motivations.
Of course Biogen can execute faster than Anavex. Biogen has Billions of $ available to fund promising research. If one of their projects fails the others are still well funded.
Anavex doesn't have access to that sort of funding.
Merry Christmas... I'm jealous. Enjoy Key West.
Ummm, How much do you think it costs to pursue an MAA or an NDA?
The company has $150 million.
Oh and by the way, orphan drug designation means that the FDA waves the NDA filing fee for Rett which is currently about $ 4 Million for 2024.
I'm not saying the compiling the data and organizing it for an MAA or NDA is a trivial task. Such a filing can be up to 100,000 pages.
Much of a filing for one jurisdiction can be reused for another.
I think you are overestimating the cost of preparing an NDA submission.
Just an aside,
The delay is not desirable for sure. It is also not worth a panic attack.
Actually that is not true. The FDA has said that it is now talking real world experience (RWE) into account when making a decision on drug approval.
That information is now part of a "satisfactory" regulatory filing.
So you don't think Rett will be approved?
Frrol, it turns out more than one thing can be true. Yes biotech requires patience etc., business at this level is also cut throat.
Probably. I didn't want to spend the time to look up how much Biogen etc. had spent developing the mabs. Knowing that if I got wrong by more than $10 I'd get jumped on so I went with many tens of millions.
Australia hasn't done anything for Anavex that it doesn't do for other companies that are running trials in AU.
It doesn't hurt that many of the sites for the AD and Rett trials are in AU and that might confer a small advantage when the TGA evaluates Anavex's drug application because the population does represent the AU population to a greater degree than say the US or Spain.
The TGA will evaluate 2-73 on the data presented. It's a safe bet that the politicians will point to the 2-73 success as a positive result for the trial reimbursement program. That's what politicians do.
2-73 will certainly knock the 2 recently approved mabs off the market and that represents many tens of millions of Dollars of R&D costs that will go down the drain.
Rett will put a big dent in Trofinetide sales if it doesn't knock it off the market..
There are three companies right there that stand to lose a lot of money when 2-73 succeeds.
And then there is that very large amount of money on the short side. Many tens of millions of $ at stake there.
So, yes there are entities that have a huge stake in seeing Anavex fail or at the least be delayed as much as possible.
Business at this level is cutthroat.
Is just me, or does it seem like the negative Nellies are working overtime lately?
Given the lack of adoption of the recent mabs it is unlikely that AD infusions are a significant part of the infusion world.
Wouldn't having all of the safety visits done and reported back to the central CRO be part of the database lock process? If that is the case then how does the company get the data before the database is locked?
What am I missing here?
All I can say in response to your post is "boy will you be surprised."
Or more likely Missling understands what the 2-73 platform is worth and is not willing to take an offer that does not represent that value.
BP is not willing to pay Missling's price, so Anavex moves forward on its own.
BP can only get a partnership and that will be on Anavex's terms.
Please explain how MMs can maintain an 18,000,000 share short position for months and months?
What Andrew means is that a request for Breakthrough Therapy designation has to be acted on in 60 days.
Breakthrough Therapy designation confers Fast Track benefits on the drug.
So it looks like Anavex is applying for Fast Track for AD. Rett already has that designation so it makes no sense that it should be for Rett.
And some of the are lawyers.
The Aduhelm mab was approved over the objections of the SRB. The vote was 10 against and one unsure. The FDA approved anyway and three board members resigned in protest.
The second mab was approved with100% of the SRB voting to approve.
The things that will have the biggest near term impact on the share price are Rett TLR and the NDA filing.
As we have just seen with the EMA letter approving the filing of an MAA, the SP impact is short term. To a lesser degree the same will be true of the TGA and the FDA applications.
A good peer reviewed paper on Rett and especially AD will have a longer term impact I think. My reasoning for that is that positive papers will make clear the likelihood of approvals when the NDAs are filed making them a foregone conclusion.
I suppose if you see the world in black and white that might be true.
For the rest of us the risk level is sliding scale. Anavex has reduced the risk over the last year by a huge amount.
If the data is good then the drug will be approved. It's that simple.
Anavex has hired a very competent team to get the NDA & MAA and whatever the TGD calls their application written and submitted.
The data will garner the approval. Rett approval will be first and AD will not be that long afterwards.
We have been told the cost of producing 2-73 is low which means margins will be high and the cost to the patient will be comparatively low. Those two items assure not only revenues but profitability for both the partner and Anavex.
The company has repeatedly said it will do Rett on its own, so no splitting the revenues with a partner there. No BP required.
So DBOT, your concerns are ill founded at the least and specious at best.
There is one thing in your post I agree with.
The timeline for the EMA is in "active" days i.e. work days not calendar days. Go through the PDF linked below to see the average timelines for EMA drug approvals. EMA approval is going to take a long time.
https://www.almacgroup.com/wp-content/uploads/2019/09/Introduction-to-the-EU-regulatory-submission-timeline-David-McCoubrey.pdf
Your argument has merit. The genes that had higher levels of expression were not prespecified so in terms of a conclusive demonstration of effect the data is not more than suggestive. That is basic stats.
The Excellence trial is also collecting substantial genetic data. If those same patterns of changes show up in the Excellence trial then the data becomes very strong because at that point the data points are no longer random relationships but appear to be causal.
Also the heat map shows patterns or clusters of genetic changes related to energy production and metabolism. That clustering is suggestive of an effect rather than a random occurrence.
Glad you liked your own post.
Anavex is well along in the process of getting NDAs filed.
It's a process. The PR showing the genomic data is very important. The same effects should be shown in the Excellence trial which is a very positive sign.
Rett NDA will be filed pretty soon and it had fast track designation so approval will be coming in 6 months after filing.
At that point it is liftoff for Anavex.
Hedging your bets on a message board to preserve your ego is fine.
Doing that while investing real money is a whole different set of consequences.
You do remember there was that little thing called Covid in Spain at that time don't you?
Well let's see...
The submission of the MAA could be 6 to 7 months from now which gives plenty of time for the oft mentioned peer reviewed paper to come out.
Missling did say that the EMA has seen data that has not yet been made public. The EMA has seen the data and thinks the process should move forward. Whether the dose-level efficacy is public or not is a moot point as far as the submission is concerned.
You certainty about the dosage-level data is quite impressive. I guess we will find out if that is an issue of not when the peer reviewed paper comes out.
Missling said that Anavex had several meetings with the EMA before they Ok'd the start of the MAA process. We don't know over what period of time those meetings took place. So it is a guess that the CHMP acted quickly.
Given the EU bureaucracy I would be surprised if it moves much faster than the regulatory timelines. If they do, that's great. At best Anavex might get the fast track which cuts the 210 day time frame to 150 days. If I am correct that is business days not calendar days.
Sorry. I missed that.
We shall see if that is right or not. It conflicts with what I can find in the regs.
Who knows, maybe the EMU has a sense of urgency about AD.
Where did this reply come from?
The EMA is setting the schedule. Anavex needs to have the MAA ready for whenever the EMA tells them that they will accept the MAA.