Anavex Life Sciences Corporation (AVXL) オプション

Just what Blarcamasine does! This is about fasting-driven esophagy...
https://www.tiktok.com/t/ZT2UjCbDG/

Looking at the stop clock process, I suspect MAA withdrawals will occur at a second stop clock. That's the point at which it becomes clear that the EMA hasn't bought the applicant's answers provided after the first clock stop.

In our circumstances, it would be many months from now before that could occur.

Thanks, I apparently didn't play much attention to it in that it proved to be so meaningless in NWBO's filing with the UK.

I do believe all the time they're taking is indicative of an approval, but specific terms are still under discussion.

I believe that investors are learning that a great deal of communications occur between the regulator and companies, but almost nothing either requires, or even permits acknowledgement by the company. From the time an admission is accepted/validated practically nothing is said about the status with the regulators that's official. At times investors who know people working trials, etc. may learn that they've been, or are being inspected, which is part of what's required to finish the evaluation. In reality, we really don't know when a poster was in some way a participant.

Gary

Sorry. Missed one. The federal reserve should also be audited. They are an independent company ran by unelected officials. They are not part of the government.

Been through this one before. You either budget so that applicants don't pay -- in which case taxpayers are paying instead of BP and other applicants (a subsidy) -- or there are user fees.

There isn't any evidence that the FDA is overcharging on the user fees. However, if you start with the premise that everything is corrupt, it saves you the trouble of proving it. That's cheap and easy, and worthless as an argument.

Every business should be audited every 2 to 3 years to keep them on the up and up. Why not, they audit individuals at will..IRS should be audited as well.

Corruption is too easy. End the monetary strings attached with big pharma.

The validation PR was on Dec 23rd, the start date of Dec 27th is given in the "under evaluation" tracker.

It's my understanding that the 210 days are the total days, not just business days, but I don't believe they start until the company is notified that their filing has been validated. I don't know if that's happened, or has ever been announced.

It's still meaningless as few filings are ended by the target date, but at least it's their goal. If as the company indicated this filing was something which was requested, perhaps the review will go rapidly and they'll actually meet, or even exceed their goal. Anything is possible, but don't hold your breath at day 210, you're likely to be very disappointed.

Gary

I follow your reasoning. We can eliminate all that FDA corruption by dropping the headcount to zero. Problem . . . er, solved.

Apparently also a bit like that with the milkman sometimes stopping enroute to deliver stuff way outside the remit of employment, while leaving other customers waiting for their order.

The FDA is corrupted and you are fooling yourself!

imanjen13

I think if you look carefully at the chart, there are 2 downlines, the minor one from $10.50 down was broken & was stopped, but the more important line down from the (double top area....14.50 area and 14.00).....so that line is $14 and down across $10.50 now needs to be broken! A move over $9 would be the area, but I need an aggressive conviction move which requires a VOLUME and PRICE confirmation!

Maybe this week will do it?

Actually, I got to know my mailman pretty well & he told me if he worked really fast they would extend his area of service, so he would from time to time, stop, pullover and read some of the magazines he was to deliver, then continue his hours at work!....or work a bit slower and get overtime! ha ha

boi568
So if December, 4 months is April 25, just as Froll predicted....I'm good with that

Thanks, I mixed 210 up with 120.

If I had to pick I'd go with your version.

Ok I see what you get.

"If all days are counted they would just say “210 days”.

They use "active days" to diffentiate from clock stopped days. The active days are calander days though. It would not make sense to express the time in working days for each MAA and then require everyone to do a calculation in their heads where they add all weekends and holidays to get the actual predicted date each time.

If you look through the EMA timetables it is done in calander days and calculating though the tabs at the bottom from the original start date to the final decision gives around 210 days (or around 7 months).
This would take the decision to late July 2025, (from start date Dec 27th) however due to clock stop 1 (on average around 3 months) and potentailly clock stop 2 (on average 1-2 months) it would be on course for around Oct or Nov/Dec.

https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/submission-dates/procedural-timetables

I suggest you look deeper into DCVax-L.  Once other therapeuticIs like POLY-ICLC are added 5 year survival goes to about 50%.  The regulators know it, though it's only been demonstrated in early stages trials.   I doubt that they will force patients to wait years to run additional trials. 

Gary 

If all days are counted they would just say “210 days”
Adding the qualifier “active” means they are not just calendar days.

The EMA uses “active” and “working” days to describe the schedule.

Asking AI “what are EMA working days” gives the answer mon-fri 8:30 am to 6:00 pm.

Looks like a mini head and shoulder pattern being completed.

It turns out AI is sometimes wrong.
The documentation from the EMA on the subject is somewhat ambiguous. That leads to AI having difficulty.

The only somewhat clear statement I could find was that the EMA counts "Active" days in its timelines. In other documentation looking at total time to actual approval, the EMA makes it clear that in that case it is using calendar days. In fact it explicitly states "calendar days".

Anyone who thinks that FDA layoffs are good news for Anavex is just fooling themselves. I can guarantee you that nobody has carefully examined the FDA roster to determine who the least productive employees are.

Sage post.

No delusion...Professional meeting attendee's! Meetings galore, work secondary...With me, work was primary...

Delusions of grandeur. The same as what some people have with this stock.

In most other orgs with the same structure as where I worked...Seven people did the job that I did...I wasn't overworked,

Assuming as it may be that a culture change is required, then firing and perhaps re-hiring under changed leadership could work. Some here will agree for example that the FDA approval of the MABS against the advisory board recommendation was not science or a proper way of avoiding an incorrect Type 1 and 2 error decision.

Musk did the big firing exercise with Twitter (and before in bits of Tesla) and many though the now X platform would not survive...I do worry about other things of the new administration rhetoric and it will be interesting to see what actually happens - probably some useful stuff and a few disasters too.

Will affect $AVXL much - probably not!

Is this a political post when it directly affects Anavex? Anyone who thinks having less people to actually do the work is going to help our country must be a total idiot. Or maybe a worm is eating your brain.
https://news.bloomberglaw.com/health-law-and-business/fda-begins-layoffs-as-trump-moves-to-shrink-federal-workforce

If you get a takeover offer, fight.
https://klementoninvesting.substack.com/p/if-you-get-a-takeover-offer-fight

"Anyone thinking we see an NDA come April.", ? williamssc
It would not be the first time an EMA country acted alone.

Regarding the EMA 210 days, the Google question to ask is this:
Is the EMA 120 day period from acceptance to clock stop 1 based on work days or calendar days?
The answer: The EMA's 120-day period from acceptance to clock stop 1 is based on calendar days; meaning it includes weekends and holidays, not just working days.

Strategy: The longer we wait the sooner we will get rich!

The UK likes medicines that work, and, as you know, NWBO's candidate provides very questionable value. I think comparing NWBO's NIH application to AVXL's EMA application is not great. AVXL seems to have pretty incontrovertible evidence that 2-73 really works for AD - in the short term and the long term. You are right that we are lucky that the PDUFA date has been treated as binding by the FDA historically (although who knows now?) and EMA's dates are much more flexible. Still, 2-73 is solid dosage, no real SAEs, and data from related trials all have surfaced no other safety issues: maybe 2-73 will run the gauntlet faster than most?

One of my big winners was Arena Pharmaceuticals which was bought out by Pfizer for $100 per share. But, 2 years prior to that, institutions owned a small percentage and the share price was as low as $12 per share. They published outstanding data for their GPCR candidate (Anavex also specializes in GPCR molecules) and institutions when from ~30% to ~90% just before the buyout. Institutions starting to pile in now is a good sign.

With everything Anavex so perfect it must be the pesky cabal suppressing the price of $AVXL - there just cannot be any other explanation!!!

The peer reviewed journal should sustain much higher sp than we have now.

Institutions now own over 40% I read somewhere, so they decide on what the price is, guess they have been accumulating since the journal came out.

Strategy, please.

LOL

I was of course to give you something to track. It helps you prove to yourself that, as I have been telling for several years now, so far Anavex have not released news that can sustain the price $AVXL at consistently higher levels.

Then what was the strategy behind a $9.56 stock purchase in January?

Other Bingo players would like to know.

This is a Lily ad for monoclonal antibody drugs to treat AD. Very well done I might add, but no mention of injection treatment mode, monitoring requirements, or likelihood of serious AEs (including sudden death).


Novel early detection methods like blood tests for amyloid, spinal taps, and MRI imaging are also mentioned, but no discussion of brain inflamation, disrupted cellular homeostasis, or impaired autophagy as root causes.


Dr. Sabaugh is convincingly effective when sharing about his father to demonstrate his commitment to this new approach to treating early AD.

I hope he is working on a follow-up video of similar quality for when AVXL gets the green light from EMA.

One wildcard no one is mentioning is other indebted developed countries may follow the U.S. and begin to reduce their government employee headcounts.
That could slow down the EMA among many other things.

Bingo! With Anavex it is always Feb'ish if ever...

NWBO is supposedly in the same sort of approval track with the UK, but we're well beyond day 300 if you want to start with final validation, and around day 400 if you go back to the original submission date.

The point I'm making is that other than the FDA which sets a PDUFA date after they accept a BLA or NDA that's normally 6 months after acceptance, or one year if it's not high priority. A big difference is that if the FDA isn't going to meet their date, they reschedule it. The others don't seem to provide any guidance, at least not anything official that must be released by the companies.

There is no doubt the regulators come to the company with questions or comments that must be answered, so they're aware of the status, but there is no commitment on when they'll finish.

I'm no fan of the FDA but they usually deliver something at the PDUFA date, or before. It may be the dreaded CRL letter, but if you're not approved you know why.

Gary

210 working days = ~10 months (250 total working days in a calendar year in Germany, for example.) So, 10months plus 3 months (Clock Stop 1) plus 1 month (clock stop 2) = 14 months total. This means no MAA approval is likely prior to end of February 2026.

Yes, a miracle could happen and there may be no clock stops but probably people should not invest based on this likelihood.

Per ChatGTP, the List of Questions (LoQ) typically occurs on Day 120, triggering the first Clock Stop. If there are items still unresolved, a List of Outstanding Issues (LoOI) typically occurs on Day 180, which triggers a second Clock Stop.

He is not applying to the FDA until a decision from the EMA. He has never had any discussions with the FDA about AVXL-2-73. He acts like Chicken Little when it comes to the FDA. For the FDA, he has to request a Type B meeting, which takes three months to schedule. He’s not even talking about it.

After 210 calendar days, we will get the LoQ. In the next couple months that follow, we will either get a PR indicating we submitted our responses, or will hear in the next CC that we either submitted or declined to.