Anavex Life Sciences Corporation (AVXL) Options

I thought we were seeing a realbrise each day last week into the close...those must have been fake rises.

Regarding blarcamesine and/or Anavex 3-71

"...The multiple functions of Sig-1R

The Sig-1R’s function is essential for metabotropic receptor signaling, which, besides their cardinal role in regulating various neurotransmitter systems, second messengers and growth factor signaling pathways, also help cells to cope with stress. At the MAM its control of the Ca2+ efflux from the ER to the mitochondria is critical for maintaining mitochondrial respiration and high-energy phosphate synthesis (Hayashi & Su, 2007). By the promotion of mitochondrial Ca2+ uptake Sig-1R improves..."

https://www.sciencedirect.com/science/article/abs/pii/S007477422500025X?via%3Dihub

Good luck and GOD bless,

Have we seen the readout from the June 16-19 CHMP review?
If not Blarcamasine MAA review may have been approved to continue.

Boi has it correct. Only thing I don't see in catching up all that posted since I posted this morning is... The CHMP meetings are held on specific dates. For 2025 dates: January 27-30, February 24-27, March 24-27, April 22-25, May 19-22, June 16-19, July 21-24, September 15-18, October 13-16, November 10-13, and December 8-11
Usually a day or so after the monthly meeting They will post to their website what companies have passed onto the next step or with drawn or more tests needed. Companies who are still IN CLOCK STOP ONE will not be mentioned at all. NORMAL is THREE MONTHS in Clock Stop One. IN some cases companies have been in Clock Stop One for SIX MONTHS.

This is a direct quote from the EMA website. "This time is interrupted by one or two ‘clock-stops’ during which the applicant prepares the answers to any questions raised by the CHMP. The maximum duration of a clock-stop depend on how long the applicant thinks it will take to respond, but must be agreed by the CHMP. The first clock-stop usually lasts three months and the second clock-stop one month. Overall, the assessment of a new medicine usually lasts around a year."

John k9uwa

Clock stop one calls for a maximum of 90 days for applicants response.
We are half way to that point.

However it appears under special circumstances that period can be longer.

When we know the clock has restarted I suspect that will boost the share price, however no idea if the response answers the MAA questions satisfactorily.

Yes Boi I am aware... but as I stated to make it crystal clear for some that I think are English 2nd language to understand. We will hear after the monthly meeting when it is posted to EMA Website.
John k9uwa

You have a gifted mind.

I once wrote a set of legal procedures that was made longer by my creating deadlines and cutting opportunities for delay by litigants or the administrative judges. Cases did move more quickly, as I intended, but the rules were necessarily longer and more detailed.

Interesting read of the chart. Makes sense to me.

Yes.

The rapporteurs don't have to like the "proper" answers. We can answer everything honestly, thoroughly, and clearly, which is proper, and the answers can be deemed unsatisfactory. Just so everyone is clear, this is not a situation of "if we answer properly then we get approved". They're evaluating our trial designs and outcomes.

It bears repeating: the folks scrutinizing submissions are not those who recommend submitting. The rapporteurs are independent SMEs.

Good for you. This AI definition still applies.

"Bureaucratic" describes something related to or characteristic of a bureaucracy, often implying excessive rules, procedures, and formality, which can lead to delays and inefficiencies. It can also refer to a system of government or management characterized by a hierarchy of officials and fixed procedures.

My experience has been that the regulators can ask anything they wish right up to the time they act.  If it can't be successfully answered it's up to them as to how it's to be handled. 
In at least one case additional trials were required. 
Gary 

Thanks Kentucky. Looks like a nice patient bloody transfer of wealth/power. Did Dr. Missling quit selling shares because of revenue is in sight or more because he was tired of them manipulating the pps down so low, into the 4’s?

powerwalker

Thanks and let's hope for immediate approval!

Chuck,

Yes, the daily does display the down slant line with some to little resistance (my view)

The Weekly does have a good indication of support from the uptrend,,,which I prefer....!

Steve

Removed

Boi,
I was on my phone earlier before this response, that is clearer to me now, thanks! The cell phone app is not as good as following on the site.

That's right, and a sometimes unreliable ChatGTP reported to me IIRC, that there's a second clock stop only 15 percent of the time.

boi
I just have to admit, I must be missing how Anavex restarts the clock, I remain of the opinion that CHMP receives the information requested and is satisfied or not! If they are satisfied, no need for more questions for Clock Stop Two (which I still believe is in the hands of CHMP not Anavex)....

boi, it would be good to note that not all applications have a Clock Stop 2. If the company responds to the Clock Stop 1 questions adequately, the application could go directly to approval (after CHMP's review) . or as Investor would claim, it could be withdrawn.

Yes, as far as we currently know, Anavex is still working on its response to CHMP's List of Questions and when they do submit their response, the "active days" clock resumes. It works this way for everyone. By the stats, not much time has gone by in this particular stop clock.

Anavex is not placing a time limit on CHMP. The EMA's procedures set a 210 day time limit on CHMP's MAA reviews. Anavex only influences how long CHMP's down time lasts while they wait to hear back from Anavex.

Some interesting zones, lines of support/resistance and trend. Ruminate on your thoughts for direction of price to take.

https://investorshub.advfn.com/uimage/uploads/2025/6/21/cmcqoScreen_Shot_2025-06-21_at_11.25.37_AM.png

Below is how the weekly closed.

https://investorshub.advfn.com/uimage/uploads/2025/6/21/waewuScreen_Shot_2025-06-21_at_11.33.50_AM.png

I do, but this one is pretty easy to understand.

Clock stop 2 isn't for questions -- it's for listing the problems that remain in the application after the company had the opportunity during the first clock stop to answer the EMA questions. It's the last chance for the applicant to fix what was wrong or incomplete with its initial MAA submission.

The clock stops are the periods during which the ball is in the applicant's court, and the active days are the time it's in CHMP's court. Either party can send the ball back to the other one unilaterally.

IF a Grand Jury can indict a ham sandwich,
EMA can accept a filing for analysis and review.

George's bot is on overdrive today.

IF that is YOUR understanding then WHY is the clock not restarted?
Is it your opinion that Anavex has yet to submit its answers to CHMP?
You imply that it is the submission that restarts the clock.
It seems to more than a few that while additional questions
may indeed arise from the review of Anavex answers @ Clock Stop one,
it is the total lack of response or one deemed inadequate but not disastrous
that leads to a CHMP decision whether to restart the Clock or suggest withdrawal.

Either way, it seems illogical that Anavex places a time limit on CHMP by
choosing to restart the Clock themselves by its submission in response to LoQ.

You have to understand bureaucratic gobbledygook to comprehend. Boi has much more practice.

If Chmp starts it up, I would expect them to also end it! Isn't that logical? If so, they would then go to stop clock 2 with add'l questions if necesssry

No Steve the dummy here💪 .. I can not even find EMA’s announcement about withdrawal..😵‍💫

Nope. Where did you get that from?

If CHMP does the clock re-start only if the applicant properly answered all of its List of Questions, what's left to do other than recommend approval?

Your understanding doesn't explain the second clock stop protocol at all.

Just clueless, tarot

Good post

A little confusing to me, I thought CHMP restarts the clock not Anavex if they had more questions AFTER clock stop one

John,
Yeah, they are very clear on how many days total (210) before it's over, but the problem is HOW LONG they can hold it to complete Clock Stop One....the market does not like uncertainty, neither do I and most others here. I assume there are some questions, but not many! I know some here like Investor and Doc328 think that without this ADL passing "go", it's a PROBLEM....but the EMA accepted the filing, right? Hey....I'm the dummy in class.

Steve

My understanding is different than yours. While we are in the first clock stop, Anavex, not CHMP, restarts the clock by submitting its response to the questions it received. We very likely will hear about this from CHMP, not Anavex.

If CHMP is not fully satisfied with the response, it will initiate a second clock stop later with a list of (unresolved) issues.

This protocol means that the need for a second clock stop is more significant than the length of a first clock stop. (The length of the first clock stop provides a clue, however, about the degree of difficulty the list of questions posed and/or the thoroughness of the company's response.)

Thank You John for clarifying this.
I have not noticed such announcement and this helps of course a lot 🤩👍

Yki we are STOPPED NOW. We are IN clock stop one. It began 25.4 April 25 It will be done when CHMP says it is done. We are at Day 120. We stay at Day 120 until CHMP says go back to counting. That might be end of June, might be end of July, might be end of August, might be end of Sept, Next will be 60 Sixty days of clock running. Then Clock Stop two. We have no way to know how long Clock Stop two will last??? And then the last 60 Sixty days before end of 210 days.
John k9uwa

Being relatively new to Stockcharts I discovered colored impaired charts. It is a wow for me.

https://schrts.co/QxDXAWFX

So on 21.7. Those 210 days are gone.
Any hunch how many days it has taken for those ’clock stop’s?

Tom:
I believe that the last high around $10 (end of April) was on much weaker volume , however the 1st one had volume March 21st) and around 8 days from there which was the last hard down.....that's the reason, imo, that the recent light reversal pointing down is offset with the recent strength and from the double bottom (April & May)

Actually, I really have not noticed a lot of resistance in the $9 to $9.25 area except for the down slant on the chart, so that does need to be broken.

That leaves me pretty bullish and I don't "expect" weakness....but the market always knows how to smack me! ha ha

Steve

Boubon

Don't forget the quarterly index rebalance which contributes to the VOLUME..

Anavex has the key to solving and even preventing Alzheimer’s disease

First map of the brain's mitochondria may explain cognitive decline

https://www.earth.com/news/first-map-of-the-brains-mitochondria-may-explain-cognitive-decline/

Good luck and GOD bless,

I don't disagree with that scenario. It's always a good idea to look at both directions . I think the technical playing field is currently looking from 8.00 to 10.00 area. 7.75/7.50 targets look a little extreme now, to me.but I'm also noticing the 25 cent steps as magnetic in this pattern.... from 7.25 to 10.25, all the 25 cent steps are active in the picture and even the 200ma and 50 ma are there at 8.25 and 8.50.
Today we saw 8.80/8.90 area holding, so far.
I sense odds are good for a pop to 9.25, maybe 9.50, but this is serious resistance territory on the technical chart, 9.25 to 9.75. , and you could draw a resistance line along the tops that angles downward, and next week should be interesting to watch.

You must own a paper and ink company.
Say good bye to the value of what you have accumulated.
Asset prices may rise (until they don’t) but they will buy much less if DC policymakers are in charge of the presses. They already have pointed us toward monetizing the debt.

From George's post 1.601M shares total for the day. This consists of MOO order 100K and the below Rebalance and MOC 1.05M
That leaves 445K trades during the day. And as George said Ended at $9.09 which is up $0.06 from yesterdays close.

And as Flakes said: "not small fry, a big fish was feeding"

The list of trades below total 1,056,000 shares. Rebalance and MOC and Afterhours.
PriceSizeTypeTime
9.15 50 Odd lot 17:13:31
9.01 205 form t 17:09:59
9.15 5 Odd lot 16:37:57
9.14 200 form t 16:36:49
9.09 940 prior ref 16:20:00
9.14 70 Odd lot 16:16:51
9.10 56 Odd lot 16:14:54
9.09 6,423 prior ref 16:11:41
9.01 1 Odd lot 16:08:36
9.15 1 Odd lot 16:07:48
9.09 1 Odd lot 16:06:52
9.09 1 Odd lot 16:04:14
9.09 1 Odd lot 16:04:13
9.09 1 Odd lot 16:04:12
9.09 1 Odd lot 16:04:12
9.09 1 Odd lot 16:04:09
9.09 1 Odd lot 16:04:08
9.09 1 Odd lot 16:04:06
9.09 34,982 prior ref 16:03:21
9.09 310,400 prior ref 16:03:20
9.09 258 prior ref 16:03:10
9.09 126 prior ref 16:02:56
9.09 244 prior ref 16:02:18
9.09 2,896 prior ref 16:01:50
9.09 189 prior ref 16:01:03
9.09 940 form t 16:00:02
9.09 7 Odd lot 16:00:00
9.09 505,213 16:00:00
9.09 505,213 16:00:00
9.07 1,685 16:00:00
9.06 200 16:00:00
9.07 1,685 16:00:00
9.07 308 16:00:00
9.07 289 16:00:00
9.07 205 16:00:00
9.07 400 16:00:00
9.07 100 15:59:59
9.07 100 15:59:59
9.07 100 15:59:59
9.07 196 15:59:59
9.07 100 15:59:59
9.07 100 15:59:59
9.07 23 Odd lot 15:59:59
9.07 500 15:59:59
9.07 205 15:59:59
9.06 1,585 15:59:59
9.06 100 15:59:59
9.06 95 Odd lot 15:59:59
9.06 205 15:59:59
9.06 200 15:59:59

Maybe this next week we do go up from $9.09.
GLTAL
John k9uwa

This is how the volume looked minute by minute today. Yes, last 30 minutes a lot of action.

https://investorshub.advfn.com/uimage/uploads/2025/6/20/nzcfuScreen_Shot_2025-06-20_at_4.59.29_PM.png

https://stockcharts.com/c-sc/sc?s=AVXL&p=5&b=5&g=0&i=t1645976161c&r=1750453869771

5 min chart with volume.

Expect real rise in the AVXL stock price to start next week or within the next fortnight and/or the next month!!!

Good luck and GOD bless,

Kund foo not happy !!