George:

Ask your doctor if a mild laxative might be right for you.

Bill

Powerwalker:
Not sure the reasoning behind it but we'll just have more trouble knowing who owns what in this case.
Bill

Clarification on Vanguard's holdings of Anavex shares:

Hey, great find!!

This is only the second or third time this link has been posted in the past year.

Brace yourself for the backlash from George. It's coming for sure. 😁

Bill

Hope this isn't our future source for manufacture of Blarcamesine.
I have seen George on a couple of occasions mention a specific manufacturer for our Blarcamesine pills.
TEVA Pharmaceuticals plant in Israel has been damaged by Iranian attack.

Update: Looks like it was the pesticide plant and fertilizer facility that were hit.

Bill

I was surprised to see that the principal has not yet removed your pc privileges in study hall.
Off to iggyland you go.

My initial reaction to yesterday’s withdrawal . .

. . was to call for Missling’s firing. I was even ready to believe that his grandfather might have been one of the Germans that bombed Pearl Harbor.

Then, I tried to understand how things could have gone so sideways in the Oral Explanation segment. Recall there was backlash by Serge Bakchine against the Alzheimer Europe publication. Not sure if he was present for the OE but I had seen somewhere that he might be. Even if not present, if incensed enough, he could have lobbied and influenced others who were. Knowing how independent the committee members are, some may have wondered if Anavex instigated the release of the AE publication. If enough members felt that way, this could have led to hostile questions during the session.

Facing a hostile crowd, Missling might have thought, “Screw these guys, I’ll just withdraw the application.”

That’s one interpretation of how things may have devolved. There are obviously others. And, before I get flamed for my lack of historical knowledge, I know it was the Italians and not the Germans who bombed Pearl Harbor.

Bill

You realize of course . .
. . that the more you respond to these chuckleheads, the more time they have to spend reading your comments when they could be working on their accordian lessons.
Bill

Post of the day.
Bill

Georgie:
Is it Ern who's buying all those shares?
Bill

I may have misconstrued rx7171's numbers. If they represent the deltas between Blarcamesine and placebo, my comments would not be pertinent.

Sorry about that.

Bill

Looking at the numbers posted by rx7171, I have no reason to challenge what they’ve provided below.

Dizziness. 26.6%
Confusional state. 9.1%
Fall +1.8% improvement
Depressed mood. 2.6%
Headache. 3.7%
Anxiety. 0.8%
Balance disorder. 5.3%
Disorientation. 5.4%

My question is: Were all of these conditions directly attributable to Blarcamesine? Could there have been other situations that contributed to these supposed side effects?

Take for example dizziness and balance disorder. Depending on the age(s) of the participants, dizziness and balance disorder are common among the elderly. At age 80, I experience these on occasion when getting out of bed. The same applies to my younger brother (age 78) and my wife (age 77). My family doctor (early forties) complains of the same conditions. These are have been shown to be due to inner ear blockages which impact equilibrium. Were the complainants checked for conditions that might have accounted for these symptoms?

What about disorientation and confusional state? I know of a lady who had been taken to the emergency room twice in the past four months suffering from these very symptoms. She was found to have a bladder infection on both occasions. The doctors said in each case that urinary tract infections are often accompanied by disorientation and confusion. UTI’s are more common among the elderly. Were those suffering from these side effects checked for other conditions that might have contributed to these symptoms?

I may be out in left field here but am unsure that all of these symptoms were in all cases properly attributable to Blarcamesine.

Bill

Unless there were changes, here are the CV’s of the two rapporteurs assigned to Anavex’s application to EMA. (I posted these on iHub on November 11 before the negative trend, etc.).

https://www.ema.europa.eu/sites/default/files/ContactsandExperts/experts_files/vrijlandtp_CV_en.pdf

https://www.ema.europa.eu/sites/default/files/ContactsandExperts/experts_files/wangi_CV_en.pdf

Dr. Vrijlandt’s background is in cardiometabolic diseases, diabetes, osteoporosis and diagnostics, and infectious diseases and rare metabolic diseases.

Dr. Wang’s background is in urology with an interest in oncology.

In any event, we had two rapporteurs with no background in CNS diseases leading our efforts.

No surprise that we had the outcome we did this week. I saw somewhere that our new rapporteurs will have more suitable backgrounds. Hopefully we’ll have two individuals who know the difference between UTI's and dementia on this go-around.

Bill

I could have said the same thing with fewer words.

"We got turned down; will keep trying but don't expect too much".

Was expecting a much more detailed response. Maybe their lawyers told them to cool it.

Bill

The ultimate payback

Given the sketchy turn down by EMA, Anavex’s next step should be to submit Blarcamesine to the FDA under a new name: PyssonEMA.

And, yeah. I'm totally pyssed.

Bill

You are correct. That assumes a negative decision in December.
In the event the vote is positive, there would be no need to request a re-examination.
Bill

Trying to read the minds of the Committee members reviewing Anavex’s application to CHMP.

Other than there was a “negative trend” when voting started last month, we don’t know the breakdown of positive versus negative votes that were recorded or the backgrounds of those who were negative or not voting. That voting was halted suggests that someone thought the application could be salvaged given time for re-consideration before the final vote in December.

That leads to questions regarding what the members may have seen and done since November. We’re told that no new information can be received or considered before the vote is finalized. That’s obviously not binding as we’re also told that information from outside will be shared with the members. Likewise, it’s not likely that members were prohibited from seeking more information on their own. It’s not like a judge telling jurors that they’re not to discuss a case among themselves. Aside from Mayo’s excellent document, there will be other petitions we don’t know about. My feeling is that positive opinions will far outweigh any negative submissions.

We should also expect there will be some lobbying in the background by positive voters to sway the votes of the negatives. There’s more positive to say at this point than negative. The lack of additional trials may have been the sticking point among some voters. This can be overcome by Anavex agreeing to conduct a confirmatory trial as a condition for approval.

I remain cautiously optimistic over our chances for approval sooner rather than later.

Bill

Could there be any possibility of this?

I don’t necessarily view the negative trend reported earlier as being final for our current submission to EMA.

Wonder if this initial disclosure was to provide the committee with leverage over AVXL in negotiating the terms of an approval.

Some of the negative voters may want to see further tests prior to granting approval (but might approve if the company agreed to conduct a confirmatory trial after approval).

They may be willing to change their votes to positive if Anavex agreed before the December meeting to conduct such a confirmatory trial.

Don’t know how many negative voters we are dealing with or how many may be persuadable if Anavex makes such a concession.

Bill

Jesse:

Thanks for compiling the questions for the meeting.

As I said in a previous post, I hope Dr. Sabbagh can be used more in future presentations.

If Dr. Sabbagh is in the meeting next week, it would be helpful if you could direct the below question to him:

“Dr. Sabbagh, in yesterday’s interview with Nancy Keach of Bright Focus Foundation, you were asked by an attendee about pricing for Blarcamesine. You responded briefly that this was something to be concerned about in the future (perhaps years). This has led to speculation that this comment may have indicated that the delay would also apply to Anavex’s future revenues. Could you add more color to your response? There are many who believe this has let to a negative drag on the company’s outlook since yesterday.”

Thanks in advance for your consideration.

Bill

Yes, it was an overbroad question.

And he gave an overbroad answer.

Too much is being ascribed to the exchange.

Bill

George:

We are presently close to the low of the day. Much ground to make up in 30 minutes to hit at or near the high.

Please stop with the foolish predictions.

Bill

I, too, was impressed by Dr. Sabbagh on today’s call.

The only thing he said that concerned me was when he said determining the cost could be years away. Not sure if he understood the import of what he was saying or if that was just a throw-away comment to a question that he didn’t fully understand.

For my part, after watching Missling for several years mumble through presentations, I wish there was some way they could integrate Sabbagh into the earnings calls and other presentations so we could have a better presentation of our case.

Bill

Missed this post on ST yesterdaty.

Posting the link for others who may also have missed it.

Note they mention that communications from outsiders may be considered by the EMA before the next meeting.

https://stocktwits.com/RHAMS/message/636694953

Bill

Your chronic juvenile cries for attention are having no effect.

Good-bye.

Welcome to iggyland.

Bill

Missling can’t afford to sit still on this.

He can’t sit by and take “no” for answer.

That there were only 20 minutes allowed for an oral presentation is laughable, even if that’s what the rules provide. Most (if not all) of the time may have been taken up by the ADL issue. One member could have dominated the entire 20 minutes. There may have been others who never got a chance to ask a question.

Missling should explore the possibility of a “blind” call with the negative voters and any others who want to participate. This could be easily arranged and moderated by the EMA team. Questions would be presented in writing and transmitted to the Anavex team. Follow-up questions could be handled in the same manner. Anavex would not know who asked the questions. It would be stipulated that no new information would be presented but existing information could be expanded on. The moderator would enforce this restriction.

This could hopefully reverse some of the “no” votes before the final vote in December.

To say that I’m highly “pee-ohed” at the way Anavex had been dealt with by the EMA is an understatement.

Bill

Trying to understand “negative trend”

The Company was informed by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) of a negative trend vote on the Marketing Authorisation Application (MAA) for blarcamesine following its CHMP oral explanation.

The first explanation that comes to mind is that formal voting had begun and a majority of those votes were for disapproval. There might still be time to turn these members around.

A second possibility is that some (or maybe most) voters were withholding their votes until they received more information regarding ADL or some other matter covered in the oral presentation. This might allow for more info to be submitted (if allowed) to the members before the final vote.

A third (and less desirable possibility) is that after all the smoke clears, my family may be eating bologna sandwiches for Thanksgiving and Christmas.
Hope that’s not the case.

Bill

Couldn't agree more.

That's another point I wanted to make in my earlier post but did not as I wanted to limit the length of the post.

You captured the sentiment perfectly!

Bill

I’ve read the many comments submitted by posters since Friday’s debacle.

I only have a little to add but hope some will find it helpful.

My first comment relates to the “negative trend” in voting. Who disclosed this to the Anavex team? Was it one of the rapporteurs or a member of the committee? Since the vote was not yet final as of Friday there must have been someone who was hopeful that the situation could be salvaged. If the vote was not final, there may still have been hope that there's time for some negative voters to change their position.

This leads me to think that the mention of the FDA’s interest in the same press release as the EMA update was a prod by Anavex that the EMA voters need to be aware of the long-term consequences of a negative decision. Should they reject the Anavex solution they are opening themselves to being scooped as the first approvers of a world-changing therapy. Presently, they have approved two solutions that have serious side effects that few want to pay for or can afford. Do they want to be seen as followers later on after Blarcamesine is approved in the US? How will that be viewed in the countries that rely on them for leadership?

This is a “fool around and find out” moment for the EMA.

I hope they choose wisely.

Bill

I have to wonder . .

. . what was going on in the minds of the voters?

I’m pretty sure that everyone reading this knows or has known someone who has/had Alzheimers. I have known several who have suffered from it and a couple who have passed away from it.

In that context, the same must apply to the Committee members who voted on our submission. They know of the weaknesses/dangers of the Mabs and the high cost. With their own family and friends suffering from the disease, how could they look at our data and vote against?

My feeling, along with that of others, is that the vote was very close with a lot of approval votes. It may only take our appeal and introduction of additional analyses that are allowed to swing the requisite number of members to our side.

Bill

Tell us, please.

How much money have you lost thus far on NWBO?

Run along sonny. You don't have what it takes to post on this board.

Bill

Is trading halted?

On my Fidelity screen, the price is stuck at $3.44 and volume stuck at 7,441,739.
Update: I see another poster saw this as well.

Bill

I saw someone purporting to be Xena posting on ST a few days ago.

Only two or three posts and then nothing further.

Bill

Possible Topic for Yesterday’s Oral Presentation

I concur with a couple of earlier posters who downplayed the likelihood that the missed endpoint would be of much concern to the Committee. It’s possible that the topic was added to accommodate a member who was not aware that the endpoint in question has been discounted in importance.

Among other possibilities, one would be for Anavex to clarify how they would finance a rollout of Blarcamisine across multiple countries should approval be granted. Recall that our business development officer was recently seen at the JPMorgan headquarters in New York. It’s possible that she was there to acquire documents showing JPM’s willingness to advance funding to finance sales and distribution once Anavex has approval. Such documents would be helpful in assuring the Committee that Anavex has the resources at the ready to undertake a full rollout upon approval.

Just speculation on my part but the timing may be more than coincidental.

Bill

With nothing else to do but wait,
I looked up the backgrounds of the two rapporteurs assigned to Anavex. Vrijlandt is from the Netherlands, Wang is from Norway.
Links to their CV’s are below:

https://www.ema.europa.eu/sites/default/files/ContactsandExperts/experts_files/vrijlandtp_CV_en.pdf

https://www.ema.europa.eu/sites/default/files/ContactsandExperts/experts_files/wangi_CV_en.pdf

There’s also a small thumbnail about Vrijlandt’s background. Note the reference to his interest in gender differences in the safety of medicinal products. Seems I recall Anavex’s focus on this subject.

https://www.escardio.org/static-file/Escardio/Advocacy/Initiatives/Cardiovascular%20Round%20Table/Documents/CRT%20&%20EMA%20%20Nov.%2021-22%202023%20Biographies/Mr.%20Patrick%20Vrijlandt,%20Netherlands.pdf


Bill

I may have missed it because I didn't read the article in detail.
But, I don't think they mentioned that Anavex started out as a printing company.
Very poorly researched.

Best wishes sab63090.
Should not be a big deal.
Went through the same thing three weeks ago.
Look forward to many more posts.
Bill

The man has a terminal case of "dumbass".

avxllent:

Ask your doctor if a mild laxative might be right for you.

Bill

Bastages to the left of us; bastages to the right of us.
Shorted and plundered.
Once Anavex reaches its true value, I’m going to use $10,000 of my gains to finance a wedding ceremony and cheap honeymoon so the parents of our primary antagonist can finally get married.

Bill

Two years ago when I blocked him
I had been thinking his name should be "Extreme BS'er Zig".
Surprised anyone here still responds to him and Investor.
Bill