Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Also, do we think Kun would join if anything was fraudulent?
If everything wasn’t done by the book, I don’t think he would have come over. Especially if the Odds Ratio wasn’t in the SAP.
Or if Missling’s statements about meeting all endpoints was inaccurate.
His statements were based on statistics not hunches.
Hold off on the PR Missling. Let’s see if I can work my magic. I don’t want my name on crap data that goes nowhere.
After finishing the final touches. There you go. I want my name all over this. Great way to cap off my career with the biggest contribution of my lifetime.
Missling - Yep this will look nice on that long list. History will remember.
Ok. PR time
Anavex was confused on how to best present the data. They could have crunched the numbers themselves and could have wasted a clear shot on goal.
Instead they decided to go to THE person that could put it all together in a way that's acceptable. This guy has seen data crunched in so many different ways, he out of all people would have an answer to our puzzle.
He understands the precedent set by other companies who maybe have used similar methods to pass the FDA smell test.
I'm not sure who approached who, but Kun had a choice, probably many choices if he wanted them.
Now he says, "I believe I can make a substantial contribution at this very important time in the Company’s transition towards commercialization.”
Not towards the next designs of additional clinical trials. Although he will be there for those too.
Deal making is in Missling's wheelhouse. He was talking about Asian partners months ago in regard to Rett and Rett just finished.
If he had that kind jump on Rett partnership talks, do we think he didn't do the same for Alz?
He had interactions with many of the major BPs through the consortium as well. I'm sure he was planting seeds and making connections along the way.
Missling sleeps and breathes Anavex. Even more than many of us which is hard to believe.
Ha Right!
But never with regulators.
Yep and don’t forget that regulatory hire as well.
There’s no doubt he’s forging ahead here and it’s all hands on deck. Hence the hold up on other fronts.
We’ve never know Missling to be anything but conservative in his speech.
Leading up to CTAD, his confidence level grew and his words became more convincing. He is aggressively pursuing approval. He said it. It’s in the JPM presentation. That is the plan.
He did not say. We will seek guidance.
All of this data confusion will be cleared up because it has to be.
Any thoughts as to whether a partnership should be inked before new data is PRd or after?
PR New Data Before Partner
-SP rises
-Stronger position for us with possibly with more cash
-Partner will have to pay more for a smaller percentage
-Higher SP may make the deal less enticing for the partner since they don't benefit from upside SP rise
-But would make it more palatable for the partner's investors to see what they're getting for such a high premium
-Possibly bidding war although I think it is unlikely. Missling knows exactly who he would/wants to partner with. And doesn't care about squabbling over pennies.
PR New Data After Partner
-Partner will benefit from the SP rise. Pretty much getting a great deal at reduced cost. That is of course if there is an equity stake.
??Anything else
Seems like new data first is the better choice for us.
Hey Kun. Why don’t you come work for us? Take a look at what we’ve got. We need you.
Damn. You’ve really got something here. Options. Kaching! I’m in.
Kun knows what is acceptable. He’s been in the room. He knows what massaging data looks like. He’s the one others have been trying to fool all the years he’s been working there. He’s the one looking for the holes in other companies’ data. He’s the one Billy Dunn or whoever else looks to and says. Kun is this legit or what? Kun says it’s good. Let’s move forward.
Did we fool him into thinking he could massage our data to fool the new Kun Jin replacement at the FDA? Don’t think so.
Anavex came. Kun saw. And they will both conquer together.
Or
What? This data is a mess. You actually told everyone you met endpoints. You actually said you are aggressively pursuing an accelerated approval somewhere. Bwahhaaaa.
You actually filed an 8K saying this. Missling. Do you have a death wish?
Ok. Count me in. This is too funny. I’m just a number cruncher anyway. My career has been a joke and this will make it even funnier. Let’s burn together!!
You don’t make a career change this late in life for a Maybe. Or for a Lotto ticket. Or for Hope.
Anavex enticed him to come by showing him what we’ve got. He’s either convinced or stupid.
I doubt he’s stupid.
Hopefully his hiring will coincide with greater institutional ownership, more analyst coverage, more publicity/articles from reputable sources, more transparency for the smart money, etc.
Is it wrong to liken him to the president’s press secretary?
Missling is setting up for growth and expansion and has been for some time. He is data driven in all that he does and this is no different. He realizes it is time for some real expertise.
The regulatory hire, biostatistician, IR, Grimmer, etc. A great leader surrounds himself with great leaders.
Thanks for the info.
So it seems we are a ways away from hearing anything given the fact that Kun Jin was recently brought in.
And if he is still working on the data, I wonder if a meeting was even requested yet.
Any thoughts as to when we should be hearing about regulator meetings?
It takes about 60 days to schedule a type B meeting with the FDA. I’m guessing others are around the same time frame.
Wondering if Missling would have scheduled shortly after CTAD since they’re familiar with the timelines.
That would be the prudent thing to do. So we should be hearing something soon. IMO
I think there comes a time in your life when you look back and reflect and ask yourself, what have I done? Did I make a difference in this world or did I just let life run it’s course with little effect?
Yes, the options are nice but I like to think that Kun came over for altruistic reasons as well. You spend your career watching drugs get approved that help very few people with your role having little effect on the outcome. You are a number cruncher and a damn good one but your mark in the world as it comes to your career is not as significant as you hoped it would be.
Then you get a chance to help bring a drug to market that can make a real difference in a company that needs your expertise desperately. It’s a place where your impact will be felt and your work valued with a lasting impact for generations.
Yes, options are nice but at some point in your life money is just money.
How do you even poach a guy like Kun Jin?
Was he retiring on his way out of the FDA?
I’m guessing he probably didn’t click the apply button while looking for companies to work for especially with his level of experience.
Was he approached by us? Did our other 2 FDA guys have a conversation with him? We need you.
Be interesting to have heard that conversation and/or other conversations that took place.
I guess once you see our data, it’s hard to say no especially when you know exactly what the FDA has said yes to.
A really nice options package to seal the deal guaranteeing him a wealthy retirement when he wants it.
Did Billy Dunn hear about his career move? Not sure how close they still work together.
“Don’t worry Billy, I’m gonna bring you Anavex with a bow on it. Wrapped up with i s dotted and t s crossed.”
“Ok. Make sure they don’t jip you on those options”
Pretty big bold move by Missling and prob not so easy to pull off. Don’t think we got him from CVS.
The plan seems pretty clear to me.
Show us the missing data, the 50mg cohort and do a head to head comparison with Lecanemab. He’s already called them out, now it needs to be done in more detail.
I bet Missling was happy to see the approval.
We met endpoints, it was better than he expected and he wants to aggressively apply for AA. Everywhere!
If he shows the data to back that up. We are golden.
Yep, a BP partner changes everything. Missling should know that. Data by itself sadly doesn’t go very far even if presented without holes.
We’ve got a few contenders. He needs to move faster than the usual Missling Speed.
Missling needs to do a grass roots campaign to get those advocacy groups on our side like he did with the rare disease foundations.
Not sure how much they’re influenced by BP money, media, etc.
Nice to see Grimmer standing by his comments and our data.
Looking forward to a JPM splash with a clearer picture of the Alz success with PDD OLE support in hand.
If we didn’t have those blank check preferreds we’d be in big doo doo right about now.
We are ripe for partnership.
Missling has recently done a couple of Asian conferences too. They have been talking to some companies in Asia already and have patents filed.
Alzheimer’s is an economic burden as Missling has been pointing out in just about every PR and presentation. Countries need relief with their aging population and will welcome an alternative to injections.
Oh wait. Maybe they should let their problem get bigger, let more people die and spend crap loads of more money for another few years.
When the best data you’ve seen in decades comes out, you give it a shot because anything is better than what’s out there now. We are extremely safe, so why the F not.
Yes. Simplifying everything quite a bit but it makes sense ethically and economically.
All I know is when your reputation gets tarnished unjustly and you get called a liar and a fraud, you want to come back bigger and better just to prove them wrong.
I pray that we woke the beast in Missling and he has vengeance on his mind.
He said pursue aggressively a few times and has never mentioned all these regulatory bodies before at the same time.
He has never said Accelerated Approval before either. Missling is ultra reserved and careful with his words. And usually says we will ask for guidance.
Never a pumper and cautious when talking about the future. This time he said. This is what we’re gonna do and this is where we’re gonna do it. And we’re gonna be aggressive. We want AA or the equivalent of.
Doesn’t sound like someone that doubts the data. Because it’s better than he expected. And to boot. I’m gonna bring in some heavy hitters to tell you how much better a pill is than an IV. Then I’m gonna show you some slides comparing us to our competition and what the FDA has approved prior and tell you that we’re better. We’re better than the one that was approved and we’re better than the one you’re about to approve.
We don’t have all the data yet, but I trust that it’s coming. I don’t know why he didn’t have it, but I’m sure there’s a damn good reason.
Missling use to speak softly and carry a big stick. This time he spoke loudly and showed you how big his stick actually is.
Like many have said. You don’t jeopardize everything you’ve worked for and risk a long list of other consequences just to present incomplete data that will be required to be verified.
Missling is mad and his kraken is getting restless.
Now is the perfect time to partner from both sides.
BP prob shouldn’t wait. You snooze you lose. It’s a race to see who can get to Missling first.
Blank checks protect us in the meantime.
For someone that has proven to be so anal and particular, people are characterizing him as being the complete opposite.
That’s hard to believe despite what we’re seeing which is only part of the story.
Missling said results were clinically meaningful which is better than just being statistically significant.
Do we really think Missling wants to deceive investors by hiding info that can be easily verified?
Do we think Missling wants to lie, jeopardize his career and our pipeline in addition to setting us up for possible lawsuits?
I’m pretty sure it’s No and No.
Then call out Biogen and make Perry possibly look stupid.
And then say the results were better than they even expected.
That would mean he’s delusional. I don’t think he is.
Delusional - characterized by or holding idiosyncratic beliefs or impressions that are contradicted by reality or rational argument, typically as a symptom of mental disorder.
Agreed. A momentous moment squandered because it was rushed and now we are the subject of major criticism with our results in doubt. Crazy!
As a layman, I’m not sure if what the street needs can be calculated in two days. Anyone?
Seems pretty tight. The last thing we want is for the clarification to be rushed again only to be criticized more. If he’s going to do this, he needs to be prepared. Missling must know that some tough questions are going to be asked.
I hope to God he is not just going over the same CTAD slides, justifying numbers. That would be a major mistake.
Hope to get a morning PR with solid, clear, unambiguous numbers that can complement the CTAD presentation that has been examined thoroughly by so many. Might even be better to say, this is what we would have liked to have had given more time and release new slides.
Biogen and Esai definitely went back and immediately parsed through Macfarlane’s presentation to see if we pose a real threat.
Other BPs are picking it apart as well for partnership, buyout reasons.
Missling has one shot to re-present our data and change perceptions.
Please don’t F it up!
Glad Missling was “forced” to do the CC on Monday. Who knows he may have been planning one regardless.
Hopefully he makes a straight comparison with Lecanemab like he did with Trofinetide.
Missling needs his PR team revved up like that Biogen media blitz we witnessed.
I think our results will be more respected afterwards.
Why would you say that? PDD was a different circumstance.
We presented great never before seen results, we were not going head to head with BP and we were always going to use the data to drive a larger trial.
I’ve been here for 8 years. And it’s all gonna pay off!
Let’s make people wait for 5 months to tell them we’ve got Jack. No way.
It’s more like. Let’s wait 5 months to analyze the crap out of our awesome results so we can make believers of all the scientists attending CTAD.
Let make our presentation irrefutable so no one can bash and even the FDA has to say, Oh Damn!!
Shock and Awe is coming!
If we didn’t beat Biogen, he would have PRd already.
If we just got a strong signal, he would have PRd and said, more details to come at CTAD about how we’re gonna use this data to design a successful P3. And he would have sold shares to boot, which he didn’t.
No reason to make everyone wait to see so so data.
TLR in the morning and then TLD in the afternoon?
If we can’t beat biogens 27%, we don’t deserve to be an Alzheimer’s drug.
Agreed. It’s winning time!
Nothing has changed. Throughout our history 2-73 has done things that have never or rarely been done.
3rd party confirmation out the wazoo.
This is Missling’s moment. Where else do you want to release paradigm changing results?
Shock and Awe time.
Hope you didn’t get shook.
"They need to go ahead and recruit more of such patients who are likely to respond, and are asking the FDA for a P4 instead of another P3,as they have enough patients in the trial who responded very nicely (Positive Spin)"
This makes sense.
I understand what Investor is saying and it makes sense in regard to finding a strong enough signal for a "real precision medicine" trial, but how many responders is enough?
I'd imagine 20-30 percent responding well, meaning stabilizing or improving, would be plenty to move on to a P4 instead of another precision trial, even if it wasn't enough to lower the P value of the entire group.
FWIW - I'm still in the WGT camp and am expecting Shock and Awe with blowout results.
He’s either dumb or he’s gonna shock and awe.
I’m going for the latter. This hope is the one thing that’s keeping my blood pressure down.
It’s the only thing that makes sense considering all that he’s done and hasn’t done.
Missling made a mistake by raising expectations with an AM CC.
He was never keen on how these things affect investors. Just like the CC last year before Thanksgiving.
Hard to rationalize the decision.
Unless it’s a Tuesday Newsday!
I couldn’t resist. Ya never know
Hey everyone, take a look at our mediocre results!
And just in case you didn’t notice, we’ve planned our CC this week too so you can be reminded that we have no revenue and are actually losing money.
As a reminder, don’t forget to watch out for our data at CTAD where you’ll be reminded of how mediocre we are.
And don’t forget, we will need to run and extra Alz trial or two, so we will be diluting the crap out of all of you.
We just wanted to do the CC this week as well to just get all the crappy news out at one time.
Any questions? I’m really excited about our future.
I guess it depends who you ask.
Missling getting the blank check preferreds years ago shows how far ahead he was thinking.
Imagine how far ahead in his planning he is now. He’s already been saying prophylactic for years. And just said they we’re scratching the surface with our platform.
He was already talking to Rett partners in Asia. This is a man with a clear plan and vision.
All his minor blunders will soon be forgotten and forgiven.
Can we say the endpoints were met yet?
I took it to mean that Monday is the TLR day.
Let’s see.
1. Missling could hold the TLR until the day of CTAD and release the data with it in one big PR. Since the presentation data needs to shared. Then he would need to have a CC afterwards some time to field some questions. The answer is just going to be: We are planning to meet with the FDA for guidance since everything that the company wants to share will be in the presentation.
2. He could have shared the TLR a different day and he would have had a CC following like he does for all our major releases. And the answers to all the questions would be. Embargo. More information to follow at ctad. Waste of time.
3. Since he wants to create some buzz and needs to release TLR some time anyway. Why not do it with the regular cc since there will be other items to talk about anyway. And can still use the line. Embargo. More info to follow.
Regardless. We need to hear from Missling some time. When else would it be?
They could have given their quarterly CC any day, even today like they did last year.
Why wait until the week of CTAD? We see how busy their schedules are. Do we think they just wanted to make it a little more challenging?
The Monday AM CC is deliberate. Do we think they want to deliberately dodge questions about our Alz trial and say you'll find out n a few days? Maybe, but that could have been done any day.
Giving us TLR that day gives him the opportunity to field some questions. I believe all/most of our big releases have been followed by a CC the day of. Why not make it a 2fer.
Time for Missling the showman to get people excited about our big day.
It’s the only one that is late breaking. We know the results of the others already.
If our news really is stellar, how will Missling be received?
As a hero or as someone who just ruined their research and possibly altering their careers.
Presenters may not even want to present their data and just say. What’s the point?
Their may be a bonfire with people angrily ripping their posters and burning them.
Biogen will present and no one will be in the room.
Hated or loved. Who knows. Tough position to be in. Sounds funny but our results have serious consequences for everyone at ctad.
Correct me if I’m wrong please.
In looking at the ctad program, it seems we are the only Late Breaking Oral that is presenting top line data from a late stage potentially pivotal trial.
Is there anything in the program that deserves more attention?
Ok. Dream time or maybe not.
If you were Missling and you have paradigm changing disruptive news, where do you want to release it? Of course CTAD - especially with a new MOA you need people to believe in.
You are handed this venue on a silver platter, do you want to release news before? Probably not, it will be old news already by then, less buzz.
Or do you wait and make an incredible splash and make your MOA the talk of CTAD with the presentation being standing room only. WIth the Biogen guys standing in the back like, Oh Damn, this is good!
So, Missling is like a kid at Guggenheim, trying his best to contain his excitement cuz he knows! His enthusiasm is busting through and he starts saying things like Remember! The doses! Wink wink
You get it. Right. Do you hear what I'm saying. High dose improves. Wink. Wink
R E M E M B E R...
Get it. Get what I'm saying. Get it.
and we heard him loud and clear. So now were getting close and people are doubting what they believed in for the past 7 years and they're doubting their ears along with it.
No, did he just say, ughh. No he wasn't really excited. He was just saying facts. he didn't mean anything. Ughh no, that data has gotta be bad.
No little Johnny! Clean out your damn ears. Did you hear what the man said??
He said WE GOT THIS! Mother F ers!!!!