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If you start with with ten patients and then have twenty that is 100% growth, i.e. growing fast.
Blackrock does a lot more than just index funds. It has a number of different portfolios that it creates and manages.
For example.
https://www.fidelity.com/managed-accounts/portfolio-advisory-service/blackrock-investment-management
I'm sure their research staff is not any better than what we learn from a message board and reading PRs and SEC filings. Lol.
A normal person would ignore him.
Sell half your shares and force the issue.
20,655,976 shares @ $6.60 = $136,329,441 short position.
Seems likely that there is some effort to protect that amount of money.
At 5% interest on that money they are receiving $568,039 a month in interest.
In answer to your question as to what is standing in the way of filing NDAs for various indications.
PDD Too small of a trial. Only one trial.
PD No trial at all for PD.
AD Filing process started in EU.
Adult Rett Small trial. I suspect the FDA would rather have a filing for pediatric and adult in one NDA.
Pediatric Rett Awaiting guidance from the FDA on the current trial. See adult Rett response above.
My guess is that the US and AU filings for AD are waiting on pediatric Rett guidance from the FDA before a decision on those filings is made.
You flatter yourself.
Many of my fellow investors here consider my FUDster-IDing efforts very noble and needed.
Very nice up day. + 9.09%
A moderator only has to follow the Ihub rules when deleting posts. If you disagree on a deletion you can always ask for a review by admin.
Aside from that there is no requirement for a mod to have a position on the stock one way or another and a mod can be just as much of a **** as any other poster.
Don't have you blocked. Only one person blocked and that is on another board.
She was not a morning person.
Link to that please?
I can predict with 100% certainty that you will continue to be a condescending PITA.
Predictions are hard, especially about the future.
Please explain how publicly dissing the CEO in the Wall Street Journal will help the share price? If anything that cause any potential shareholder to reconsider buying.
Why do you think the Mayo has any skills that are not already on the board? The guy does a very good job as an information gatherer and analyst. The board already has access to all the information that it feels it needs.
Good question.
My sense is that your #2 item is correct. A good peer review will establish the MOA and the legitimacy of the approach to CNS.
I doubt that the company would be making so much of the peer review paper unless they thought it was going to be a positive for the company.
Actually several PRs have mentioned that decisions were made based on discussions with the FDA.
So, swing and a miss on this one.
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.
Selling covered calls would be a better idea on this one.
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.
I doubt that many MAAs will go straight through without ever touching the walls within the CHMP offices.[/quote
Actually the average length of time for the EMA review process of New Active Substances averaged 436 days in 2018.
With the Accelerated Assessment option the average was 230 days.
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.
Contains Nonbinding Recommendations
B. Type B Meeting
Type B meetings are as follows:4
• Pre-investigational new drug application (pre-IND) meetings (21 CFR 312.82)
• Certain end-of-phase 1 meetings (21 CFR 312.82)
• End-of-phase 2 and pre-phase 3 meetings (21 CFR 312.47)
• Pre-new drug application/biologics license application meetings (21 CFR 312.47)
Type B meetings should be scheduled to occur within 60 days of FDA receipt of the written meeting request. If a sponsor or applicant requests a meeting date that is beyond 60 days from the date of request receipt, we will work with the sponsor or applicant to determine the earliest agreeable date.
To promote efficient management of formal meetings, the requestor should try to anticipate future needs and, to the extent practical, combine product development issues into the fewest possible meetings. Generally, we will not grant more than one of each of the Type B meetings for each potential application (e.g., investigational new drug application (IND), new drug application (NDA), biologics license application (BLA)) or combination of closely related products developed by the same sponsor or applicant (e.g., same active ingredient but different dosage forms being developed concurrently), but we can do so when it would be beneficial to hold separate meetings to discuss unrelated issues. It also may be appropriate to conduct more than one of some of the Type B meetings for concurrent development of a product for unrelated claims.
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).
Standard MOC trade.
Fidelity shows 152K shares traded at close. 16:00:00
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 NDA
The NDA (38) includes all data concerning the drug; all information about the manufacturing process and facilities, quality control, and assurance; a complete product description (chemical formula, specifications, pharmacodynamics, and pharmacokinetics); indications; labeling; and proposed risk evaluation and mitigation processes if applicable. A typical NDA can run 100,000 pages, and according to the Office of the Federal Register, the application fee in 2016 for an NDA that requires clinical data is $2,374,200 39, 40. The FDA has 60 days to determine if they will file the application once it is received (41).
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.