https://www.pmlive.com/pharma_news/pfizer_maintains_lead_in_top_cns_drug_sales_-_just_734480?SQ_DESIGN_NAME=2&;

Perfect match. 2015 article.

Missling probably had potential partners picked out years ago.

Make a clean deal. No need for chaos or bad actors.

This is in his wheelhouse.

True. So disruptive to so many.

Missling needs muscle. Pfizer??

Yep!

Then our Platform!

Yuuge!

If the words improve or reverse are highlighted in our results, we pop big.

At least 5B increase in MC. Possibly 10

Maybe not immediately but it will get there very shortly afterwards

Forgive me if this was asked before.

On slide 40 of the corporate presentation, why does is say, “Demonstrated improved MMSE and ADCS-ADL through 148 weeks for ALL patients”?

In reference to those 2 graphs that have been discussed multiple times.

Thanks

Nothing wrong with tomorrow Missling.

One week after Biogen.

"What they have in hand is the best currency a biotech on the verge of exploding"

In reference to options, hiring and deal making.

Having cheap shares ready to explode can also make a deal with a potential partner that much sweeter.

And as many have stated, locking up a partner now has numerous benefits.

If the data is good, he will release it asap. Otherwise it will be seen as suspect.

The sooner the better. Don’t want market turmoil to take away from our headline.

Timing matters. Maybe not in the end but it surely does now.

We know Missling likes to do comparisons hence the Trofinetide slide.

A perfect set up for a shot across the bow.

Missing needs to strike while iron is hot. He should try to take advantage of this news cycle while the Biogen results are still fresh in the minds of media.

Waiting longer may give off the impression of massaging data.

So is it safe to say the primary endpoints were met yet?

So I guess we can say it was success. Now to what degree is what matters.

Doing just as well as BIIB would make us a winner. Since we’re a safe pill.

Pretty low bar.

Any words like Reverse or Improvement will be well received. Very well received

I think Missling is fully aware of the battle he has in front of him. He has been preparing. First armed with science, a stack of cash, blank check preferreds and soon a partner with influence.

This paradigm shift that he is trying to make happen will require much more than a convincing trial, though it is a great a start.

I think a key aspect is main stream media. They need to help change the narrative. Not sure if this is Missling’s forte. If he’s smart he would hire a better PR team or better yet, use our partner’s. A true medical breakthrough which is what I pray that we have will be difficult to squash.

If the headlines say, Reverse, Stabilize, Safe, etc. then there will be no stopping. Articles will have to be written and analysts will have no choice but to cover. The snowball will get bigger and people will need to move out of the way.

Everything says we’re better. The science has spoken and is saying we have something that works. I and you and so many here will be absolutely shocked if the outcome contradicts the 7 years of research that paved the way for this moment.

Yep. And it’s probably better for us to get a BP partner sooner rather than later.

Missling def knows exactly who he wants to work with. He and his team have probably been structuring a plan for a deal just in case. They know what it looks like and what percentages would be shared.

Some have speculated that they could be working on one. I guess if it’s all planned out, Missling could just slap it on the table and say. What do you think? This is what we’re willing to do. Missling would deal fairly and what company would say no?

So I guess, the BP could just say. Give us a few days to look over it and we’ll get back to you. Then done deal.

With a BP partner we’ll have distribution etc. set up, no threats from others, more sway with the FDA, more street cred, etc.

I guess that would be a good way for Missling to come out swinging. Ducks already lined up. No games. No uncertainty.

Sometimes data is just so good you look stupider trying to trash it.

Sometimes data is just so good you have no choice but to cover it.

The little guy doesn’t win much in this arena but when they do, it’s real good!

Let the Biogen news get digested. Let people realize that it’s still pretty crappy although it’s the best that they’ve ever seen. Let people realize that it doesn’t make too much a difference in the QOL.

Then show them what a real treatment looks like.

This paradigm shifting, history making story was tailored for us. For this moment.

Seize the FN day!!

So if the primary endpoint wasn’t met we would have heard already?

No doubt they have it. Is there? Thoughts.

TIA

That data can’t be spun and needs to come out.

Oh, he’ll present. This is his wet dream scenario.

I’m calling for news next week. Get ready!

Everything we have ever seen has always been good and has gotten better.

Ok Missling. Take the weekend to craft that mega PR.

Then announce that you will do your victory lap at CTAD in the most coveted time slot in the biggest room.

Then give the finger to all those who doubted us and boxes of tissues to all the CNS BPs that are crying.

Then go over to the FDA and Medicaid and say Your Welcome!!

Good point about the pricing. It will definitely be a huge hurdle for them get wide coverage.

What a gift this could be for us to provide a stark contrast in so many different aspects.

The FDA probably regrets being so lenient with the Aduhelm decision and would love a way to get a new standard set. Too bad that precedent has been established for them.

We can give them a way out. Our cheap, safe drug would be welcomed!

Our results need to be too good to ignore.

It’d be too easy to squash the “little” guy with the smallish “p2”/3 trial.

I hope Missling spit out his German beer when he saw the PR

-Reduce decline. Ha!! Amyloid again!! Ha

How about
-improvement
-reversal
-less dementia
-stabilization
-mini aspirin
-homeostasis
-safety

Clearly we have different goals and are in a different league.

Seems like a good time for a Missling Btch slap.

Or even a Will Smith

Not sure Missling or any company for that matter would want to make a deal prematurely. They certainly would not have been dealing in hypotheticals.

Missling could only speculate if an approval is even warranted.

It would take a long time to iron out the details of a deal like this.

Missling should be trying to make the run up happen.

Too many reasons not to.

From the CTAD Program

Tuesday - Nov 29th
Lecanemab Phase 3 Topline Results

Wed
Topline phase 3 - Gantenerumab

Several other results being released as well. Many Oral Presentation, Late Breaking slots still open. Not sure this is up to date.

Has anyone seen any PR's from other companies about CTAD?

Missling, time to come out and play. Where the F are you?

The PDD OLE is probably not a true “Catalyst to Drive Value”. And the Fall date is probably not traditional language for a presentation like this. “Fall” and “OLE” are more for shareholders and investors to add anticipation and “fluff” for lack of a better term.

2H and Trial Initiations - more traditional, serious, professional, etc.

Makes sense.

And bodes well for our Alz trial since the PDD patients were more impaired and still showed an improvement that correlates 70% with the adas-cog.

It was pretty cool. He said a lot of prophetic things and had the WGT aura even back then.

No. Just a layman tryin to make a dolla out of 15 cents.

And learning from the many generous people on this board who share their expertise daily.

I’ve been super pissed about the pace of progress as well and pretty much agree with everything you’ve said on that front.

Pretty shitty that we’re in this position right now without a safe cushion. Meaning the PDD P3 as you mentioned that should have been completed.

“Basically it's all or nothing on the p3 alz trial.”

I don’t think it will be a nothing. If it’s not as good as hoped for, we will def get a signal on where to go next.

We had no run up going into this. We’re being valued without the Alz potential right now. So if it’s a flop, we obviously drop but it will not be over. With Rett alone, we will get a chance to recover and go to new highs.

And if we do get a strong signal, despite not meeting endpoints, we may still even go up.

I feel like a complete failure probably should have been out by now. There’s only so long they could delay that news.

Anyway, I’m very optimistic here given everything we’ve seen. I’m feeling news this week on the CTAD front or the TLD. It would be shameful to have ambiguity around CTAD. We belong there and these results belong there.

If there’s a paradigm shift happening. You wanna make a lot of noise. And that’s a good place to start.

Sorry KEM came before.

The whole precision medicine biomarker approach came out from their work with Illumina. I believe the work with KEM came afterwards.

https://www.anavex.com/press-releases/-anavex-life-sciences-provides-clinical-programs-update-and-reports-fiscal-first-quarter-2018-financial-results

As you can see from the PR, he used this as a jump off for the Rett, PDD and Alz trials.

The fruits of all that labor is being revealed shortly.

There’s no transcript. He said it to a group of us after his presentation at an ASM during 2016 or 17. Can’t recall which year.

We were gathered around him having some refreshments and he said it in response to one of our questions.

I reported that response to the board after coming back from the CC.

That is also where he said the “tip of the iceberg” statement, which he’s repeated on several occasions.

Thinking back to that meeting. He knew exactly what he had. He also just finished doing some work with Illumina at that point with rna and dna sequencing and said he was relieved when he got the results. He didn’t expand on that there.

The year after, he campaigned to get the 10 million blank check preferreds passed.

We would be in the ultimate bizzaro world if we had a complete failure for Alz.

-all the papers on our moa
-gene pathway evidence
-RWE from patients and docs
-effect in patients -old, young, frail, etc
-completely safe with mostly only positive side effects
-fast acting
-multiple indications
-now longer duration with healthier patients

And then you have all the preparation and building within the company. For good reason. Because they can see the writing too.

Everything points to winning and more winning. A complete failure would contradict everything we’ve seen for the past 7 years. It would call into question our moa and platform potential.

So much evidence that says we have something that works.

I can’t think of one example medical or not where there is so much evidence leaning towards one outcome and then in the end you get something completely contradictory. And while working with better circumstances.

Amyloid dying

BP scrambling

FDA flopping

Anavex rising

Trials thriving

Share price flying

Shorts crying

Late comers whining

Science shining

No denying

He’s got our ip protected. He assembled a team of experts. He’s got the blank check preferreds.

He’s FN ready. It’s showtime.

Story book ending!!

I figure no matter what Missling would want to announce something in the next week or two.

If the results are just mediocre, he would want to announce a CTAD presentation and raise money on the sustained rise for the next steps. Good opportunity.

If the results are stellar, he would want to announce TLD first and explode then have a sustained rise into CTAD where more info would be released. Good opportunity.

If he just needs to submit a placeholder then he’s be a big dummy not to. And no need to wait until the last minute either.

No more hiding. No more playing it close to the vest. No more top secret plans. Show us the freakin cards!! All in mofos!!

Yes, if not by the first week of October. I learned to be patient with the science.

The CTAD is a must do and will be pissed if they don't show as should everyone else.

It's Fall and CTAD is here. Perfect set up.

-Don't Fuk it up!!

Not even sure we need a voucher. If Alz results are irrefutable, we skip the line. FDA wants a win here. No way we wait like everyone else.