ADVFN Logo ADVFN

Trending Now

Toplists

It looks like you aren't logged in.
Click the button below to log in and view your recent history.

Hot Features

Registration Strip Icon for pro Trade like a pro: Leverage real-time discussions and market-moving ideas to outperform.
Anavex Life Sciences Corporation

Anavex Life Sciences Corporation (AVXL)

8.24
-0.02
( -0.24% )
Updated: 10:02:52

Calls

StrikeBid PriceAsk PriceLast PriceMidpointChangeChange %VolumeOPEN INTLast Trade
2.004.108.400.006.250.000.00 %00-
3.004.905.400.005.150.000.00 %00-
4.003.904.600.004.250.000.00 %00-
5.002.853.603.383.2250.000.00 %020-
6.002.052.803.032.4250.000.00 %01-
7.001.301.902.181.600.000.00 %02-
8.000.751.000.900.8750.000.00 %090-
9.000.400.550.500.4750.000.00 %0392-
10.000.200.300.250.25-0.04-13.79 %327209:58:20
11.000.100.200.150.150.0550.00 %411009:57:37
12.000.050.150.100.100.000.00 %0457-
13.000.100.100.100.100.000.00 %0123-
14.000.050.450.050.250.000.00 %0347-
15.000.100.450.100.2750.000.00 %030-
16.000.180.350.180.2650.000.00 %0101-
17.000.050.400.050.2250.000.00 %0299-

Real-time discussions and trading ideas: Trade with confidence with our powerful platform.

Puts

StrikeBid PriceAsk PriceLast PriceMidpointChangeChange %VolumeOPEN INTLast Trade
2.000.000.500.000.000.000.00 %00-
3.000.000.500.000.000.000.00 %00-
4.000.050.500.050.2750.000.00 %010-
5.000.050.500.050.2750.000.00 %020-
6.000.100.200.100.150.000.00 %0100-
7.000.200.350.200.2750.000.00 %0369-
8.000.450.700.600.5750.000.00 %0280-
9.001.001.351.201.1750.000.00 %0116-
10.001.852.151.722.000.000.00 %039-
11.002.703.002.202.850.000.00 %05-
12.003.504.003.603.750.000.00 %010-
13.004.505.200.004.850.000.00 %00-
14.005.706.200.005.950.000.00 %00-
15.006.607.100.006.850.000.00 %00-
16.007.608.100.007.850.000.00 %00-
17.008.608.900.008.750.000.00 %00-

Movers

View all
  • Most Active
  • % Gainers
  • % Losers
SymbolPriceVol.
SXTCChina SXT Pharmaceuticals Inc
$ 3.85
(358.33%)
195.07k
WAFUWah Fu Education Group Ltd
$ 6.4599
(260.89%)
69.01M
ONVOOrganovo Holdings Inc
$ 1.17
(217.07%)
126.55M
FMTOFemto Technologies Inc
$ 6.71
(87.60%)
30.08M
GDCGD Culture Group Ltd
$ 2.52
(65.79%)
1.24M
YYAIConnexa Sports Technologies Inc
$ 0.74
(-41.73%)
2.93M
SNDKSanDisk Corporation
$ 49.31
(-35.27%)
1.01M
ATPCAgape ATP Corporation
$ 1.06
(-33.75%)
787.08k
DGNXDiginex Ltd
$ 48.00
(-30.78%)
52.98k
CLNEClean Energy Fuels Corp
$ 1.915
(-29.34%)
2.57M
ONVOOrganovo Holdings Inc
$ 1.17
(217.07%)
131.61M
WAFUWah Fu Education Group Ltd
$ 6.4599
(260.89%)
69.51M
NVDANVIDIA Corporation
$ 126.79
(-2.68%)
55.98M
DMNDamon Inc
$ 0.37
(21.75%)
55.11M
BREABrera Holdings PLC
$ 0.79
(25.14%)
49.72M

AVXL Discussion

View Posts
BAR123 BAR123 10 minutes ago
Our investment group has a contact within the company who communicates regularly with the Investor Relations team. She keeps us updated on all correspondence and calls she has with the IR team. There are a number of actions the company could take to curb short-selling, protect the stock price, and make raising funds at a higher valuation more achievable. We’ve seen steady but slow growth from institutional investors, and yes, the shorts continue to grow as well. I’ve heard repeatedly that short covering will be significant once the Peer Review is out, or when the OLE data is released, or when the EMA accepts our application, or when the FDA allows us to apply for approval—but remember, they haven’t even met with the FDA yet. When was the data released? Quite a while ago.

Our group has suggested that the company executives make a small purchase of shares on the open market—5,000 to 10,000 shares each. This would send a clear message. We understand that using corporate funds for a share buyback may not be the best option, but consider this: a $2 million buyback at $8 per share would buy back 250,000 shares. That, too, would send a message.

Is Missling the issue? Most would agree that he hasn’t met his commitments over the years, and this remains an ongoing issue. Did he mishandle the Rett trial? Probably. Did he mishandle the release of the Alzheimer's data? Yes. Does he have Wall Street’s support? It certainly doesn’t look that way.

We’re not necessarily suggesting he leave the company, but perhaps it’s time to bring someone in who has strong connections on Wall Street to take on the role of President while keeping him as CEO. Yes, we are a small company, but if he is the reason Wall Street isn’t fully backing us, this needs to be addressed. If we truly believe our drug has the potential to become the largest drug in history, we should be able to attract a strong president.

Apologies for another rant so soon, but there are clear steps that can be taken to protect shareholders and enhance the company’s prospects from both a management and financial perspective.
👍️ 1
Investor2014 Investor2014 24 minutes ago
70% is more realistic than >83% chance of approval - all we can do it wait and maybe trade a bit of $AVXL in between now and Feb'ish 2026.
👍️0
hnbadger1 hnbadger1 2 hours ago
Grok 3 (Deepsearch) gives us a 70% chance of approval by EMA in
2025.
“ Conclusion
In conclusion, blarcamesine has a strong case for EMA approval in 2025, with a 70% estimated probability, driven by significant cognitive benefits, supportive biomarker data, and a favorable safety profile. The missed functional endpoint introduces risk, but the overall data package and regulatory flexibility for Alzheimer's treatments, especially given the challenges with ADCS-ADL in early stages, suggest a likely approval within the year, pending the review's outcome. The user's belief that both the EMA and FDA may de-emphasize ADCS-ADL is supported by research on its sensitivity, and potential alignment in regulatory approaches could further favor approval.”

Thanks Bio Friend on Stock Twiitz
👍️ 3
plexrec plexrec 2 hours ago
Bio---this should answer some of your questions--from Stocktwits board:
dnfrs
Yesterday 4:59 PM

$AVXL
FACT: Institutions have been buying.(over 40% now)
FACT: The JPAD peer reviewed article had 58 knowledgeable scientists sign it.
FACT: The OLE data was very positive. More to come.
FACT: EMA accepted the blarcamesine application (over 90% are approved)
FACT: In a few months Anavex 3-71 phase 2 Schizophrenia data will come.
FACT: EMA results by end of 2025
FACT: Submissions in UK, Canada and Australia expected by end 2025.
FACT: The general market is rocky.
FACT: Nothing Anavex can do about the general market.
FACT: Nothing Anavex can do about Institutions holding down stock to buy.
FACT: Many good biotechs are down.
But a lot of good news has come and a lot is coming.
I don't know a better stock to buy and hold!

1


29
👍️ 2 👎️ 1
Investor2014 Investor2014 8 hours ago
So even in oncology evaluations the vast majority of MAAs have 2 clocks stops, a few more than 2 and only 1 had just 1 clock stop.

I note that the review you posted refers to Median calendar days! In other words depending on the specific MAA and circumstances the evaluation time varies.

Note also that the review is specifically on oncology, an indication viewed as time critical.

Would interesting if a similar breakdown has been done for CNS indications.
👍️0
Investor2014 Investor2014 8 hours ago
I believe active days can effectively be and often is a much longer calendar day period. There are many external activities and pauses in the overall EMA process, where EMA staff is not actively involved in a particular evaluation.

The clock stops being two such non-active periods, where EMA is waiting on the sponsor’s answers to an LoQ or perhaps the assigned EMA staff are working on other MAA’s etc. within their capacity and priorities.

The EMA has defined that altogether 210 of their active days are set aside to complete each MAA evaluation.
👍️0
Guzzi62 Guzzi62 9 hours ago
Here is the timeline for cancer treatment products in PDF:

https://www.ispor.org/docs/default-source/euro2024/isporeurope24cervelobouzohpr86poster144868-pdf.pdf?sfvrsn=ebd2a543_0
👍️ 2
Steady_T Steady_T 9 hours ago
There is a difference of opinion on the board as to the 210 day being calendar days or active days. To me active days are defined as Monday through Friday less holidays.

I am of the active days opinion. There are others here that think it is calendar days.

This is what the EMA says. You can interpret it as you wish since it is not very clear.

The evaluation of medicines, step-by-step
The assessment of a marketing authorisation application for a new medicine takes up to 210 ‘active’ days. This active evaluation time is the time spent by EMA experts to evaluate the evidence provided by the applicant in support of a marketing authorisation application./quote]

https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/evaluation-medicines-step-step
👍️0
skitahoe skitahoe 10 hours ago
I had expected the same thing from NWBO's filing in the UK, both have essentially the same time tables. Unfortunately we're now nearly 14 months from our submission, a few less from full validation, and still expecting the approval any day.

All I'm saying is these regulators do run behind, and still put at least some of the blame on Covid 19. I hope we do better with the European people, the fact that they asked the company to apply could be a big advantage. I'm just saying don't be too disappointed if it's late in 2025 or even early 2026.

Gary
👍️ 6
dia76ca dia76ca 10 hours ago
"The entire marketing authorization evaluation process usually takes 210 days." (calender days)
If the blarcamesine application follows the "usual" amount of time there could be EMA approval some time in July.
Or it could come earlier or later...maybe a month either way.
Is that how most posters see it?
👍️ 2
Citrati Citrati 11 hours ago
Shouldn't take too long for todays daily chart hammer candle close and the rising green 100period to resolve if this level support holds or not.
Extended the box in case the resolution drags out. 4ema still stuck negatively stacked under 8 and 13 ema's and price battling 100period.

https://investorshub.advfn.com/uimage/uploads/2025/2/24/rnriyScreen_Shot_2025-02-24_at_9.00.58_PM.png
👍️ 4
bb8675309 bb8675309 12 hours ago
Or a criminal syndicate. Whatever U want to call it.
👍️ 4
kund kund 12 hours ago
Another cabal theory. The biggest cabal is none other than TGD—every time he opens his mouth, the stock tanks. He might have even asked his friends at Maxim to short it so he can get cheap options.
👎️ 2 👺 1
bas2020 bas2020 12 hours ago
The answer is simple... the price is controlled by the WS mob: HFs/MMs that work to manipulate the price of many stocks to maximize profits via created volatility. At this point with AVXL, leading up to approval, they and their institution buddies, will continue to manipulate and suppress the SP in order to shake loose shares and allow themselves to accumulate on the cheap. Their mission is to create a counter intuitive "reality" that creates FUD in retail holders' minds, causing them to sell.
To be a successful trader, one has to anticipate their moves and trade accordingly. Otherwise, one just needs to hold and accumulate lower.
👍️ 13 👏 4
kspar1 kspar1 13 hours ago
Nailed. Dang, it looked so right coming out my fingers...
👍️0
Hoskuld Hoskuld 14 hours ago
BAR123, no company can answer questions about share price - they are not in control of share price. And there are analysts with $40+ share price targets.

Squeaking is not going to get it done. They need to execute. And maybe they are doing so now. They filed the MAA, they expanded the 3-71 P2, and they are about to launch a properly sized trial for PD.
👍️ 4
kund kund 15 hours ago
There is no new trial starting—Buffoon misspoke about the PD trial at JPM. Most of the time, he doesn’t even understand what he’s talking about. At JPM, he couldn't clearly articulate the company's achievements in simple words; EMA submission and peer review, he fumbled, struggling to find the words to complete his sentence. All PRs has some or other problem, no clarity is the biggest issue with his management style. The market has zero trust in his leadership, which is clearly reflected in the share price.
👎️ 2 👺 2
crescentmotor crescentmotor 15 hours ago
Missling's a veteran of IMGN and probably learned his sense of timing from them.

Yes--I bought my first IMGN shares around 2000. Indeed, I had forgotten about "NOOS" being substituted for "soon" when applied to Missling's timelines he provided investors. Unbelievable that some 25 years later, Missling still underperforms when it comes to investor guidance. Gosh Gary, we've been playing this stock market game a long time.
👎️ 2
boi568 boi568 15 hours ago
Anavex does not control all the elements of timing, and if that one element that I think has gone missing, I don't see how Missling could say anything that would improve the situation.
👍️ 1
skitahoe skitahoe 15 hours ago
I forget if you were in IMGN back when Mitch Sayare was CEO. Back then when Mitch said something was happening soon we spelled it backwards, NOOS, as his soon sometimes took years. The one thing I'd say about him was that when he said something would happen, eventually it did.

Missling's a veteran of IMGN and probably learned his sense of timing from them.

That said, I will say that he makes a fair number of presentations, so I'll give him credit for trying. The key as always is gaining approvals, hopefully Europe is just the first place he's going and others will be following in short order.

Gary
👍️ 3
crescentmotor crescentmotor 16 hours ago
Then come out and say it. Just a few weeks ago he had that chance with the earnings call. He said nothing. Either hit the dates that you say or tell us why you missed.

It is inconceivable, after all the missed/inaccurate investor guidance over many years, that anyone would not agree that AVXL's low stock price is at least somewhat attributable to Missling's failure to provide meaningful and timely guidance regarding drug/trial timelines. I continue to grade him an F in this regard. The sad and unimpressive truth is that he seems to not realize (or perhaps he just doesn't give a damn) that accurate shareholder guidance and related timely execution is one of the keys to executive management credibility. Once a CEO loses credibility, that loss of credibility tends to extend/apply to all aspects/undertakings of a company.
👍 3 👎️ 1 👺 1
Lacey1 Lacey1 16 hours ago
If the changes have to do with the new admi istratin. That's nothing but a plus for anavex.
👎️ 1 👺 1 🤣 1
Citrati Citrati 16 hours ago
Every one of those questions, IMO, has been answered ad nauseam recently except #6 and #10.

If that is truly the situation, my suggestion is for all of you to go ahead and sell. Two positives. The believers can buy more shares cheaper and the disgruntled can set aside their Xanax prescriptions.
Just my opinion for #10 conclusion not an actual recommendation. I am an unqualified anonymous internet poster with no credentials or professional standing. Buy or sell at your own risk after your own DD.

As for #6, if you look at institutional holdings, State Street Corp invests in many of the same bios as Baker Bro. However, they are not twins and both have holdings the other doesn't. I also don't consider Vanguard Group and Blackrock, lightweights. IMO, all 3 are heavyweights/Tier 1 institutions.

PS: add up their shares. Not insignificant holdings.
👍️ 2
williamssc williamssc 16 hours ago
Well ~24 million short shares keeping stock price in check doesn't help. Regardless of shorts, if AVXL progresses through the EMA process successfully, stockholders and humanity will benefit.
🎯 4 👍️ 4
dia76ca dia76ca 16 hours ago
FACT: Institutions have been buying.(over 40% now)
FACT: The JPAD peer reviewed article had 58 knowledgeable scientists sign it.
FACT: The OLE data was very positive. More to come.
FACT: EMA accepted the blarcamesine application (over 90% are approved)
FACT: In a few months Anavex 3-71 phase 2 Schizophrenia data will come.
FACT: EMA results by end of 2025
FACT: Submissions in UK, Canada and Australia expected by end 2025.
FACT: The general market is rocky.
FACT: Nothing Anavex can do about the general market.
FACT: Nothing Anavex can do about Institutions holding down stock to buy.
FACT: Many good biotechs are down.
But a lot of good news has come and a lot is coming.
I don't know a better stock to buy and hold!
🏆️ 2 👋 4 👍 3 👍️ 18 🧠 1
BAR123 BAR123 16 hours ago
Then come out and say it. Just a few weeks ago he had that chance with the earnings call. He said nothing. Either hit the dates that you say or tell us why you missed. If he starts the trial tomorrow does he get a free pass? No he still missed his date.
👍️ 2 👎️ 1 👺 2
Hosai Hosai 16 hours ago
A lot of your points came down to "the company prospects must be bad coz the sp is low", however share prices don't always fairly reflect companies prospects.
On FDA approval in July 2024 Verona fell back to $15 and now 8 months later is at $65.60. You can never predict when things get priced in.
👍️ 6
boi568 boi568 17 hours ago
I'll try to answer the Parkinson's trial start delay. Considering that Missling has been accurate in the past on deliverables when the date is just a couple of weeks away, what could possibly have happened in late January either at the company or at the FDA during those couple of weeks? (Hint: It wasn't a change of leadership at Anavex. Things seem normal at Anavex.)
👍️ 3 💯 1
boi568 boi568 17 hours ago
Yeah, I think we're well past the point where the EMA screeners will be surprised to learn there's only been one trial.
👍️ 4
BAR123 BAR123 17 hours ago
Here are my questions for the board and hopefully the company if they answer my call.
1. If we had ground breaking release with the peer review and the ole data, why hasn't the bump to $14 not held.
2. If we submitted to the EMA with the ground breaking data and peer review why hasn't $14 held and why aren't we at $36 right now ( a $3B Market Cap )
3. If we have increased out institutional holdings to approximately 41% why hasn't $14 held and why aren't we at $36 right now?
4. If we have all this great data out there and probably great results on our schizophrenia why isn't the stock at $50 right now?
5. If the company believes that the stock is undervalued, why aren't they doing something about it? Do they want a higher stock price? How about a modest stock buyback, $2M? That is not a lot. Executive share purchases, a modest 10K shares each. These guys have money, only $80K each now. Sends a huge message.
6. How come after all the great news we don't have (yet) a major analyst from a top tier firm praising us and giving us a $50 price target like all the other 3rd tier analysts. How come we do not have a top tier BioTech fund following us like a Baker Brothers?
7. Why has the company reverted back to its old ways of not hitting their self imposed dates, ie start of the Parkinson's trial. Remember end of January. We are now at the end of February. The company even thought it would be the end of the last year.
8. The only reasons that is out there is the institutions are not finished buying in yet and they still have time or we really do not have this nailed just yet and we are not de-risked.
9. Now we are waiting for the "clock stop" . Once we pass that are we de-risked? There is always a carrot out there?
10. I'm afraid that the only thing that changes this is approval or partnership and that could be 6-12 months away. I also believe that the time is now for us to get vocal with the company and demand that we have them focus on us, the shareholders who have stood by them for the last 10 + years. I have written the Chairman of the Board, the CEO and certain Board members. The squeaky wheel gets the oil and we have not received ours. The institutions are getting there oil if indeed they are buying in. We are down to $120M and we have a new large trial starting soon. We might be forced to do a bad partnership or sell stock at $5 per share if we linger here. I'm getting mad as hell ( as are all the others I brought into this company ) and people are getting pissed off and they are not going to take it anymore.
Comments please.
👍️ 2 👎️ 1 👺 1
nidan7500 nidan7500 17 hours ago
Thanks very much for the rules insight . Are we all being directed-led by the rules to follow a process of continuous trading chaos ?
👍️ 1
kund kund 17 hours ago
Compliance with Regulatory Standards: Check Which standard? Anvex own standard?
👎️ 1 👺 1
123tom 123tom 17 hours ago
Yes, I see this, ... interesting chart to look at.
This bounce at 8.01, is gonna show us what the trading force is displaying, about how the "market" feels at this 8 dollar target... as buyers stepped in here, took it up 50 cents/55, and now we see a 50% Fib pullback, and buyers jumping in again, but it doesn't climb, 🤔 ... this is a good day to be watching this price action, and the next few days.
The 8 dollar support step has a chance to establish itself as a primary bottom base, and how might that look on the chart. Support holding now, 8.20/8.30 area, and another rally climb to retest 9.00 and maybe complete around 9.40. As a finished Fib target. And turn around the downwave pattern, of lower lows lower highs. One can plot the pattern picture like a road map. But right now, I'm watching the overhead resistance zone for capping and rolling over. 8.45 to 8.75 area. For clues.
👍️ 3 👎️ 1
Hoskuld Hoskuld 18 hours ago
Well...almost true:

The expectation is 2 P3 trials and 2-73 is one trial short of the mark. But, we are hoping for a pass this time.
👎️ 1 👺 1
williamssc williamssc 18 hours ago
This will all come down to whether Blarcamesine is a safe effective drug and the gravity of the issue it is treating.

1. Scientific Data: Check
2. Risk-Benefit Profile: Check
3. Compliance with Regulatory Standards: Check

I certainly see no boogeyman here.
🎯 4 👍️ 11
Citrati Citrati 18 hours ago
Interesting that after the opening 35minutes buying/accumulation came in and price was moving up, yet even though the buying continued price was consistently pushed down. Almost like an invisible hand upon it. Last 3 minutes heavy buying yet hardly any upward reaction.

https://investorshub.advfn.com/uimage/uploads/2025/2/24/yyvvhScreen_Shot_2025-02-24_at_2.17.47_PM.png

Compare how closely AVXL moved with XBI on a 5minute chart. Sector action played a role IMO.
👍️ 4
baltimorebullet baltimorebullet 18 hours ago
I like the Aaaargh!
👍️ 1
plexrec plexrec 18 hours ago
Bar---thank you !!!
👍️0
Investor2014 Investor2014 18 hours ago
You might just ask ChatGPT as follows:
Is an accepted EMA MAA most likely to fail clock stop one or clock stop two before being withdrawn?

ChatGPT answer:
When a **Marketing Authorization Application (MAA)** is submitted to the **European Medicines Agency (EMA)**, the review process includes **two "clock stops"** where the sponsor must respond to the EMA’s concerns before proceeding. If an MAA is ultimately withdrawn, the failure point is more likely to occur at **Clock Stop One** rather than Clock Stop Two. Here's why:

### **1. Overview of EMA Review Process**
- **Day 0–120: Initial Review**
- The EMA’s **Committee for Medicinal Products for Human Use (CHMP)** conducts a preliminary assessment.
- By **Day 120**, the CHMP issues a **List of Questions (LoQ)** outlining major concerns.
- At this point, the clock stops (**Clock Stop One**) to allow the applicant to respond.

- **Clock Stop One (3–6 Months)**
- The applicant provides additional data or justifications.
- If the concerns are **serious and unresolved**, the MAA may be **withdrawn** or proceed with reservations.

- **Day 121–180: Second Review Phase**
- The CHMP evaluates the new responses.
- By **Day 180**, if concerns remain, a **List of Outstanding Issues (LoOI)** is issued.
- The clock stops again (**Clock Stop Two**), allowing the applicant to submit further clarifications.

- **Clock Stop Two (1–2 Months)**
- The applicant submits final justifications.
- If concerns persist, a **negative opinion** is issued, and the company may opt for withdrawal before formal rejection.

---

### **2. Why Failure is More Likely at Clock Stop One**
- **Major Deficiencies Identified Early**: If the EMA raises fundamental efficacy, safety, or manufacturing issues in the first round, the applicant may **choose to withdraw rather than continue** if the required data is difficult to generate.
- **Insufficient Data Gaps**: If the **clinical trial results are weak** or **bioequivalence is not demonstrated**, it’s hard to fix this later in the process.
- **Strategic Withdrawals**: Companies may **voluntarily withdraw** their application after Clock Stop One to avoid a formal rejection, which could hurt future re-submissions.

### **3. When Would Failure Happen at Clock Stop Two?**
- **Marginal Issues Remain**: If initial responses were promising but did not fully resolve all concerns, the CHMP may issue **additional questions**.
- **Regulatory Risk Assessment**: If a sponsor believes the CHMP will vote negatively, they might withdraw just before formal rejection at **Day 210**.

### **Conclusion**
An MAA is **most likely to fail at Clock Stop One**, as major issues tend to be identified early. However, failure at **Clock Stop Two** is possible if responses remain insufficient. A company may choose to withdraw at either stage, but **early-stage withdrawals are more common** to avoid a formal negative opinion.

Would you like insights on specific past cases where this has happened?
👍️ 3
plexrec plexrec 18 hours ago
Steady--"The clock stop refers to the approval process time"--thank you very much for that explanation--very helpful !!!!
👍️ 1
dia76ca dia76ca 18 hours ago
Aaaargh! Like many I am not selling any day soon. So she can pull the football away all she likes! I am waiting for a touchdown...not a field goal!
👍️ 2
baltimorebullet baltimorebullet 18 hours ago
Maybe Lucy will let the share price run up late Friday/early Monday and then pull the football away later on.
👍️0
123tom 123tom 18 hours ago
Today plunged to the 8 target.
I'm watching resistance now, 8.40 and above. The rolling over zone continues to be 8.40- 8.70 area. And I might guess the downwave distance is the standard 1 dollar. A bullish bias might like this bounce at 8 dollars to buy.And a bearish bias might be waiting for lower lows to continue into the 7's. From the recent wave pattern peaks, the 1 dollar moves, would target 7.85 area, 7.50 area. The higher rollover wave peaks at 9.65/9.30/ and 9.00 have been hit.
We're still seeing a downwave pattern , lower lows, lower highs.
👍️ 5 🧠 1
BAR123 BAR123 18 hours ago
The European Medicines Agency (EMA) uses clock stops to pause the evaluation of a medicine application while the applicant answers questions. The clock restarts when the applicant responds.
When do clock stops occur?
Day 120
The first clock stop begins after the CHMP adopts a list of questions for the applicant
Day 180
The second clock stop begins if concerns persist after the first clock stop
How long can a clock stop last?
The first clock stop for standard reviews usually lasts about 81 days
The first clock stop for accelerated reviews usually lasts about 24 days
The applicant can request an extension of the clock stop by filling out a template and submitting it to the EMA
What happens after the clock stops?
The CHMP reassesses the application after the applicant responds to the questions
If the application is successful, the EMA adopts a positive opinion, and the European Commission legally adopts it into a marketing authorization
The entire marketing authorization evaluation process usually takes 210 days.
According to the EMA guidelines, clock stop rules are based on calendar days; meaning that the time period is calculated using all days of the week, including weekends and holidays, not just working days.
Key points about EMA clock stop rules:
Calendar days used:
The timeframes for clock stops are measured in calendar days, not just working days.
CHMP approval needed:
The duration of a clock stop must be agreed upon by the Committee for Human Medicinal Products (CHMP).
Justification for extensions:
If an applicant needs a clock stop longer than a standard period, they must provide a justified request to the EMA.
👍️ 8 🙂 1
Steady_T Steady_T 18 hours ago
The clock stop refers to the approval process time line days. It is expected (hoped for) to take 210 working days.
After the initial period of time (120 days) the rapporteurs usually have some questions about the submitted materials. Those may be asking for a clarification for some statistical treatment, additional information about trial processes etc. At the clock stop period, the questions are presented to the company to be answered. The company has up to 3 months to provide the requested information. The clock starts counting again when the company provides its answers. That may be in 2 weeks or 90 days, however long it takes to provide the answers.

When the clock starts again the rapporteurs evaluate the answers and proceed with the application processing.
At 180 days clock stop two occurs. The rapporteurs will present any outstanding issues to the company. The company has 30 days to respond to those issues. At which point the clock starts counting again.

Theoretically by day 210 the CHMP has finished processing the application and make a recommendation on application approval.
Frequently the CHMP does not get things done as rapidly as the timeline would suggest.

For the EMA description of the timeline go to the link below.

https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/evaluation-medicines-step-step
👍️ 8 😀 1
dia76ca dia76ca 19 hours ago
Why do I trust that there will be an EMA approval for blarcamesine? Because Europe has a huge and growing problem with aging dementia patients and their health care systems cannot handle it! They reluctantly approved the Anti-amyloid Mabs but they expressed concerns about their safety , low efficacy and high costs. Blarcamesine is safer, more effective and more affordable! It will be approved based on solid science. And that approval will be quickly followed by approvals in the UK, Canada, Australia and Asia...sales in the multi-billions! I agree with those who predict a rocky market...but in such a market Anavex will shine all the brighter!
🎯 2 🏆️ 2 👍️ 9 🧠 2
plexrec plexrec 19 hours ago
" first potential clock stop soon?"---could someone please explain---significance (meaning) of a clock stop in the approval process !!!!! TIA
👍️ 1
rx7171 rx7171 19 hours ago
First clock stop is at 120 days.
If calendar days that puts it end of April.
If working days that puts it end of June.
👍️ 2
nidan7500 nidan7500 20 hours ago
Excellent news...thanks...shodan
👍️0
ExtremelyBullishZig ExtremelyBullishZig 20 hours ago
Many did on recommendations from George.
👎️ 1 👺 1