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I suspect a peer reviewed paper is not cause for a meeting. Perhaps a supporting document in concert with other docs to discuss a specific agenda item.
Meetings with the FDA are not casual affairs. The documents and information have to be provided to the FDA well in advance of the meeting to allow the FDA people involved to review and come to the meeting informed with their own thoughts and questions. The guidance and recommendations that result from a meeting are considered to be the official position of the FDA. As I understand it those are not legally binding but one challenges the bureaucracy at one's own risk.
As I see it a peer reviewed paper would be included in an NDA as a supporting document.
Doc can weigh in on this. I see a peer reviewed paper as legitimizing the company's statements about a trial outcome. A more in depth review and analysis of a trial and the conclusion derived from the trial. It should have sufficient information to allow knowledgeable people to arrive at their own conclusions concerning the trial methodology and results.
A positive peer reviewed paper will be taken seriously by the biotech investing community far more than the company's pronouncements about a trail and the results.
There are clearly defined meeting types for meeting with the FDA. Each meeting type has its own requirements in terms of time frame, required submissions, subject matter areas etc.
The meeting request, regardless of the method of submission, should include adequate information for the FDA to assess the potential utility of the meeting and to identify FDA staff necessary to discuss proposed agenda items. The meeting request should include the following information:
1. Product name.
2. Application number (if applicable).
3. Chemical name and structure.
4. Proposed indication(s) or context of product development.
5. Type of meeting being requested (i.e., Type A, Type B, or Type C). If a Type A meeting is requested, the rationale should be included.
6. A brief statement of the purpose and objectives of the meeting. This statement should include a brief background of the issues underlying the agenda. It also can include a brief summary of completed or planned studies and clinical trials or data that the sponsor or applicant intends to discuss at the meeting, the general nature of the critical questions to be asked, and where the meeting fits in overall development plans. Although the statement should not provide detailed documentation of trial designs or completed studies and clinical trials, it should provide enough information to facilitate understanding of the issues, such as a small table that summarizes major results.
7. A proposed agenda.
8. A list of proposed questions, grouped by discipline. For each question there should be a brief explanation of the context and purpose of the question.
9. A list of all individuals with their titles and affiliations who will attend the requested meeting from the sponsor’s or applicant’s organization and consultants.
10. A list of FDA staff, if known, or disciplines asked to participate in the requested meeting.
11. Suggested dates and times (e.g., morning or afternoon) for the meeting that are within or beyond the appropriate time frame of the meeting type being requested.
12. The format of the meeting (i.e., face to face, teleconference, or videoconference).
The FDA has said that it likes to see peer reviewed papers. Is it a requirement? No. It does represent another review process from a different set of eyeballs.
My guess is that Anavex has been working on 2 or 3 different drug applications of late.
It seems likely that they were working hard on the Rett NDA with the expectation that the trail results would allow for immediate NDA application.
They also have been working on the MAA with the EMA as we have seen with the recent authorization to proceed on AD.
Now that the Rett process is up in the air I would suspect that Anavex is also working on the AD NDA for presentation to the FDA.
There is some commonality between the EMA MAA and the FDA NDA for AD and there are a lot of differences. The EMA requires drug labels and literature in 24 different languages for example although that is not due until 215 days into the CHMP review process.
The disease, the progression of the disease, and any biomarkers of cancer are much better understood than CNS diseases.
Probably the most important is the ability to see the tumors and cancer cells via diagnostics such as x-rays, MRI etc. CNS has nothing like that degree of clarity into diagnosis and disease progression or regression. Some CNS diseases are getting better in genetic diagnoses but in regards to treatment there are still questionnaires and patient history logs compared to shrinking tumor size for cancer.
Case in point , how variable the placebo response was in the recent Rett trial. ADAS-COG is known to be highly suspect over the short term as are most observational scales.
Another post that contributes nothing to the board. Why bother?
Just like Mayo, Anavex is the only stock you report on. For someone looking for outsized returns in a high-risk sector you have a very restricted portfolio in that sector.
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Anavex Life Sciences Corp (AVXL) 02/07/2024 05:21:48 PM 4,284
The Question and Answer Board (IHUB) 08/21/2023 01:16:07 PM 1
Can Fite BioPharma Ltd (CANF) 12/05/2017 09:55:47 AM 1
Interleukin Genetics Inc. (fka ILIU) 08/08/2017 04:45:19 PM 1
Adhera Therapeutics Inc (ATRX) 11/08/2006 02:44:02 PM 4
Does anyone care that you noticed?
Actually the words he used were backup plan.
Remains to be seen what the FDA has to say about it.
The existing sites can be used if a new Rett trial is required. The sites will need an update on the protocol changes which won't be much.
I am disappointed that there was no new information about the FDA meetings and no mention of the TGA.
All in all it wasn't worth getting up early for.
That also explains why the shorts are after Anavex. History is on their side.
We will see if Dr. M can get Anavex to the other side of the valley of death to revenues.
Sorry. I have made my opinion clear. No need to discuss it further.
It's not like it matters who made the initial evaluation of the request for central marketing procedure. The point is the request was approved and now the MAA procedure has started.
No. I don't agree.
More likely the CHMP is the group that reviewed the initial request for centralized procedure. They are the group that has the expertise in that area for the EMA.
By the way, Anavex had no choice but to apply for the Centralized procedure. That is a requirement for CNS drugs.
The CHMP plays a vital role in the authorisation of medicines in the European Union (EU).
Centralised procedure
In the centralised procedure, the CHMP is responsible for:
conducting the initial assessment of EU-wide marketing authorisation applications;
assessing modifications or extensions ('variations') to an existing marketing authorisation;
considering the recommendations of the Agency's Pharmacovigilance Risk Assessment Committee on the safety of medicines on the market and when necessary, recommending to the European Commission changes to a medicine's marketing authorisation, or its suspension or withdrawal from the market.
Where did you see that sequence?
It would not surprise me if Missling did not PR the letter of intent. Making that public allows everyone to start a clock including the shorts.
I know there is an accelerated review process available with the EMA once the MAA is filed. I don't know if there is a possible path to shorten the time from letter of intent to MAA submission.
As early as possible means just that. We don't yet know exactly what is possible.
MAA filing is 7 months after the letter of intent. So far we haven't had any information on a letter of intent being filed.
You picked a really bad example for a company rewarding loyal shareholders.
LQR share price opened at $300 when it first went on the Naz and has since dropped to $2.50. That performance makes AVXL look like a blue chip stock.
LQR has lost money every year and now it is giving shareholders a dividend of a share for every 2. Really? That looks pretty desperate to me.
Anavex is a developmental biotech trudging through the valley of death for pre revenue companies.
What people seem to forget is that Anavex only has to get it right once to make the company a success and reward shareholders very well.
I get that Rett was an unexpected stumble, at least to many of us, even so Anavex still has multiple opportunities to get it right. Clearly it is not happening a fast as people would like. Caca occurs.
Rehash of the company PRs mostly.
The difference is Gingko Biloba is an OTC herb supplement and is relatively cheap. 2-73 will be a drug that will only be available by prescription and will be much more expensive. Not to mention that unless some agency approves 2-73 it won't be available for anyone.
Apples and oranges comparison.
My bad. I should know better than to argue with you.
I have a request/suggestion. When the list of posts is shown on a stock board all the various emojis are shown along with a total emoji count.
I think it would be helpful of the emojis were shown in descending order so you would have a sense of the sentiment by looking at the emoji order.
Now one has to open the post to see the counts and determine what the emoji are indicating about the sentiment related to that post.
Does that mean you have finally sold your 11 million shares?
You can't handle the truth.
The truth is you don't know and neither do I.
We can speculate all day long.
I'm not defending anyone. I'm telling you that you are out of line calling people liars all the time.
Have you talked to Jin? Do you know why he took the job?
There are many reasons he may have had for joining Anavex. Unless you have had him tell you why he joined Anavex your guess is no better than anyone else's.
Aren't you a former CEO? I would think you would have a good idea of what is involved in running a company with a multi million Dollar budget that is running multiple projects simultaneously.
That couldn't be a disingenuous comment could it?
I guessed you missed the word "maybe" in his post. That takes out of the declarative statement category i.e. outright lie, into the insinuation category which is not a lie by any definition.
insinuation
noun
An unpleasant hint or suggestion of something bad.
His post may have been tacky or perhaps just stating a possible different explanation for a set of circumstances.
Either way calling it a lie is huge overreach on your part.
Georgejjl when are you going to quit accusing anyone that posts something you don't agree with of posting lies?
Many of us have made money on Anavex. There are the day traders, the swing traders, options traders, and those of us that have a core position, which we hold, and a smaller amount of trading shares.
There is another opportunity to make a few bucks coming up. We are told that every time there is a conference call the share price drops. So sell some shares now and buy them back after the CC drop.
If you aren't making money on Anavex you may want to reexamine your approach.
Wishful thinking.
Lawsuit is coming ...
There is no "pivot". Pivot means turning away from something towards something else.
There is no indication that Anavex is turning away from 2-73. Currently Anavex is waiting for guidance from the FDA about Rett. Can Anavex file based on what the trial results are, does it need to run an new trial, if so how big and how long?
AD is in progress with the EMA. My guess is that Anavex will decide what to do in the US and AU based on the feed back it gets from the FDA on Rett.
Starting work on 3-71 has been in the developmental pipeline for quite a while. The P1 has been done and was successful so now on to P2 trials. All part of the normal pipeline development process.
Drug development is never easy. Ask NWBO.
Very interesting new findings on neuron health in AD with possible restoration of function.
https://medicalxpress.com/news/2024-02-scientists-potential-synapses-alzheimer-disease.html#google_vignette
So what's your point?
People attack the CEO and people defend the CEO, what's the problem?
And it is your duty to protect the great unwashed from him? Sorry, but that is pretty sad. Following him for years you say. Wow. My choice of the word obsession was well chosen it seems.
Like I said., board noise, like many others.
That is a ridiculous answer. You are staying with Anavex because you feel it is your duty to counter balance stuff on a minor message board. Really?
I assume you have no money at stake in this endeavor. If that is the not case your reasoning makes absolutely zero sense.
I am fascinated by your obsession with George. Most of his posts are just so much board noise like many other posts and posters.
The ninny wars continue.
Doxing (sometimes written as Doxxing) is the act of revealing identifying information about someone online, such as their real name, home address, workplace, phone, financial, and other personal information. That information is then circulated to the public — without the victim's permission.
I hub rules prohibit Doxing. Notice that doxing is real names and real information. An I hub alias is already public information and is anonymous.
I hub will not reveal the real identity of an alias without a court order.
Another reason that sleep apnea causes problems is you don't get into deep sleep which is when the brain moves the metabolic wastes out of the brain.
A new study conducted at the University of Rochester Medical Center has found that brain activity during deep, non-REM sleep is ideal for the brain’s glymphatic system to “clean” itself of toxins. Some of these include the toxic proteins beta amyloid and tau, the buildup of which has been linked to Alzheimer’s and dementia. Beta amyloid and tau are thought to harm and inhibit communication between neurons.
“Sleep is critical to the function of the brain’s waste removal system and this study shows that the deeper the sleep the better,” said Maiken Nedergaard, co-director of the] Center for Translational Neuromedicine at the University of Rochester Medical Center and lead author of the study. “These findings also add to the increasingly clear evidence that quality of sleep or sleep deprivation can predict the onset of Alzheimer’s and dementia.”
This study emphasizes the link between poor sleep and Alzheimer’s and underscores the importance of maintaining brain health as a part of a complete approach to fighting Alzheimer’s.