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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.
Notification of intention to submit an application
Applicants should consider the date of submission carefully, referring to the published submission dates and the guidance below:
Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines
Update: To notify the Agency of the intended submission date, applicants should send the pre-submission request form via EMA service desk, selecting the tab 'Business Services', category 'Human Regulatory'. The subcategory to be selected is 'Pre-Submission Phase - Human', followed by the sub-option 'Letter of Intent Request'.
If you do not have an EMA account, please create it via the EMA Account Management portal. For further information or guidance about how to create an EMA Account reference the guidance 'Create an EMA Account'.
Presubmission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application
When: 7 months before submission of marketing authorisation application
More information: Pre-authorisation guidance – section 2: Steps prior to submitting the application
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Appointment of rapporteurs
The Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC) appoints (co-)rapporteurs to conduct the scientific assessment.
For advanced therapy medicinal products, (co-)rapporteurs are also appointed from members of the Committee for Advanced Therapies (CAT), who will lead the assessment.
More information: Pre-authorisation guidance - section 2: Steps prior to submitting the application
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Pre-submission meetings (recommended)
Pre-submission meetings are the best opportunity for applicants to obtain procedural and regulatory advice from the Agency:
Marketing authorisation application (MAA) - pre-submission interactions form
Successful pre-submission meetings along with the information in the guidance should enable applicants to submit applications in line with legal and regulatory requirements. This speeds up the validation process.
When: 6 to 7 months before submission of marketing authorisation application
More information:Pre-authorisation guidance – section 2: Steps prior to submitting the application
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Re-confirmation of communicated submission date
Applicants should re-confirm the submission date initially communicated to EMA, or inform EMA of any delays or cancellations, following the guidance below:
Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines
Update: If the planned submission date is changed, applicants must inform EMA by re-sending the completed pre-submission request form, stating the new intended submission date in the corresponding field. It must be sent via EMA Service Desk, selecting the category 'Business Services' category 'Human Regulatory'. The subcategory to be selected is 'Pre-Submission Phase - Human', followed by the sub-option 'Notification of Change Request'.
If you do not have an EMA account, please create it via the EMA Account Management portal. For further information or guidance about how to create an EMA Account reference the guidance 'Create an EMA Account'.
Holding successful pre-submission meetings and following this guidance should enable applicants to submit applications in line with legal and regulatory requirements, speeding up the validation process.
When: 2-3 months before submission of marketing authorisation application
More information:Pre-authorisation guidance – section 2: Steps prior to submitting the application
Submission of the application
Submission of the application
Applicants should use the electronic common technical document (eCTD) format and submit the application through the eSubmission gateway or web client.
If EMA needs additional information to complete its validation of the application, it will ask the applicant to supply this by a deadline.
More information:
What is eSubmission?
Pre-authorisation guidance - section 4: Submission, valiadation and fees
Ummm. Anavex hasn't submitted an NDA to the FDA for anything....yet.
I don't think Anavex has submitted it MAA yet. Submission of the MAA is what starts that clock.
As I understand it the EMA is now starting its end of the process where it appoints SMEs to examine the MAA once it is submitted. The EMA time frame for this stage of the process is 7 months.
As I understand the EMA procedure Anavex can't submit the MAA for 7 months after the letter.
Don't know about that. There is plenty of time to buy back before Feb'ish.
George, turns out you are right. This year the last day for tax loss selling is Friday Dec 29th because the market is closed on the 30th and 31st.
Sorry George you got that one wrong.
It all depends on tax-loss harvesting, an approach in which investors typically sell their losing stocks and bonds to offset taxable capital gains made elsewhere. For most mutual funds, the deadline to sell is Oct. 31, while retail investors have until Dec. 31.Oct 25, 2023
Your post has very little relationship to the real world.
The simple minded view you have of the process doesn't seem to include the P1, P2, P3 trials, meetings with regulators etc. The process is much more than filing an NDA. The NDA is a step very close to the end of the process.
Biogen went to Europe first and didn't actually file anything? Weird that you see the process as being the same. So far, Anavex has not gone through any process.
They didn't. Biogen did multiple trials, submitted an NDA and that NDA took about the average amount of time to gain approval.
You can argue that the drug should have been approved or not, but Bigen went through the same process that Anavex is currently going through.
It's not like you can pop down to the 7-11 and pick up an NDA.
There is a process that has to be gone through. It's a long and carefully structured process designed to protect the public from drugs that don't work or have a bad side effect to benefit ratio.
All the things you list are part of the process.
Yeah I get that it takes a long time. I, like most others, would like the process to go faster.
Keep telling yourself that.
Totally worthless post.
It is certainly possible although Anavex has not released any information on that.
It is important to understand that rolling review does not shorten the time for approval. The 6 months clock for an FDA decision doesn't start until the last section of the NDA is submitted. What rolling review does is allow the FDA to examine the submitted sections and determine if there are any questions or requests for additional information concerning the submitted sections. Ordinarily such requests or questions would add time to the 6 month decision clock. So getting those issues, if there are any, out of the way before the 6 month clock starts keeps the 6 month timeline intact.
No. That should have been caught by the central CRO when it is compiling the trial results and locking the data base.
What he is missing is that same argument applies to the placebo group. Which explains one of the reasons that placebo groups are utilized. They wash out such effects in the statistical analysis.
That was a pretty lame argument.
As I understand it that would be a board of directors decision. The BOD could accept the bid, reject the bid, or choose to put it to a shareholder vote.
Anavex has sufficient takeover defenses in place to prevent that scenario.
At worst I think that would start a bidding war. Anavex has the ability to delay any takeover long enough for Rett to be approved and at that point $35/sh would not be a viable bid.
The FDA was the one dictating the adult trial. I do not think Anavex had a choice in the matter.
Independent... Well, they are separate trials with different trial population selections criteria.
They are the same drug treating the same disease, just in different age groups.
The FDA treats drugs for children with different standards for safety than it does for adults. Children are treated differently because they are still developing and growing so they have more opportunities for things to go wrong.
Since you or I haven't seen the full data you or I don't KNOW if the endpoints were met or not. The company has said the endpoints were met. Clear cut has no particular meaning in this case. The outcome is binary. The endpoints were met or they weren't.
If you want to say the data didn't exceed the endpoints, that's fine. However I suggest you wait till all the data is available before making that statement.
Most likely because the FDA suggested that the Pediatric trail be completed so the drug can be labeled for children as well as adults.
Why go through the approval process twice?
The people with Rett that 2-73 can help the most are the very young.
So sure of yourself based on speculation.
That is an indisputable fact...
If there are not any more of the catalysts announced before Dec 31st there will be a lot of wailing and gnashing of teeth. I will be one of those bitching about Missling at that point.
True that there have not been MS trials of 2-73. If fact 2-73 has not been approved for anything as of now.
That is not to suggest that 2-73 won't ever be approved for an indication. Once it is approved for one indication that opens the door for additional trials for other indications.
Missling is building a moat around 2-73 so that if it does turn out to be a "wide spectrum" CNS drug Anavex will have strong protections to move forward.
Go to clinicaltrials.gov and read the exclusion criteria for each trial.
Looks more like the sign of a long term investor rather than a trader.
There are some of us here that have long term core holdings and a smaller portion of trading shares. When there is a serious possibility of positive news, the trading shares become holding shares till the situation becomes clearer.
Turns out there is more than one investing/trading strategy that works. Ask leo about how he approaches Anavex.
Biogen may have thought that they could pick up the molecule cheap when Anavex went BK as so many developmental bio techs do.
Perhaps Missling wanted more for the drug access than Biogen was willing to pay, or they may not have thought 2-73 didn't have enough MS potential.
We won't have any insight into that unless Anavex runs a MS trial and we see how the results turn out.
but where will $AVXL be by Feb’ish?
AFAIK there haven't been any 2-73 trials on humans for MS. In vitro tests done. I don't recall if there were murine tests on the MS model or not. Falconer might know that.
The more appropriate wording would be "hasn't yet gotten an NDA". The MAA process has started.
We don't know where Rett is in the NDA process.
Love your choice of words, "scrape by." What an emotionally loaded descriptor of the situation. AD approval is a binary event. There is no "scrape by."
I suggest you take this discussion to the SAVA board unless you are suggesting Missling pursue a similar strategy.
No matter how you slice it, the company has made significant progress and is close to having multiple NDAs filed.
How soon the Rett NDA will be filed is unknown to us but it can't be very long.
And for some posters dissing Misslling, no matter what he accomplishes, is better than admitting the company is set up for success.