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Although current regulations permit drug approval on the basis of an effect on an unvalidated surrogate marker, a sponsor who wishes to obtain approval on the basis of the effect of a drug on such an unvalidated marker will need to adequately address the numerous thorny issues attendant to demonstrating that any such effect will be “reasonably likely” to predict the desired clinical effect. The evidence that will support such a showing, which may include animal data (both clinical and histopathological), human data (pathology as well as clinical) as well as require further investigation into the pathophysiology of the condition under study and into the pharmacology of the drug(s) under study, remains to be determined.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC534924/
Seems Missling has most of those checked off. Understanding our MOA which seems to be rare in the case of CNS diseases is big plus.
Question - We know there are not many surrogate biomarkers to be used for Alz. Are we coming to a point where the FDA or other regulators will consider a suite of positive biomarkers to be more powerful than one individual unreliable surrogate?
Just some damn clarity tomorrow. Is that too much to ask for?
Come on man!!
We don’t need all the data. Just something anything. Please!!
There are citing Nasdaq market rules for the change to its board. Curious that it took this long to comply.
Page 8 on the proxy. Director Independence
Speculation Machine - While our partner doing extensive DD - Guys you don’t even comply. You gotta fix that.
I thought about that at first too. Is this all about Missling oversight because he screwed up the Alz among other things?
I don’t think it is. Otherwise it would be Missling’s head on the chopping block. Who knows, maybe this is a step in that direction if ever needed. No doubt he’s been slow.
An Alz mistake would egregious enough to warrant removal. Also, he’s been making a lot of seemingly positive moves. Bringing on Kun, the PR guy along with all the other hires, etc. That seems like a CEO who is leading.
Who knows. I could be wrong and there could be a toxic work environment and all those people hired are there because of the board and Missling’s poor micromanaging-style.
Im leaning towards the former. I’m glad the the much needed oversight nonetheless.
A move in the right direction.
I know we shouldn’t expect anything new on Monday but I kind of am.
He could have easily just skipped this conference. No one would have noticed.
Coming out after 4 months with no new info and just different color slides would be embarrassing. It would be a slap in the face to shareholders. Why come out and purposely do something that will make people upset?
No need to present if that’s the case.
Whatever it is, it is a move in the right direction on many levels.
I’m leaning towards it not being about Missling’s screw ups.
A lot of pieces are coming together. The completion of trials, the patents, the hiring spree, the Lincoln Park deal, the delaying of other trials despite hearing about the Parkinson’s, and now this.
It just seems more like a company gearing up for growth rather than an oh crap, we gotta fix this.
Ok. I’m here to beat the dead Kun horse again.
Did Missling approach Kun to say. Please save us. We don’t know what the fk we’re doing. We need you or else this trial was all for naught. Then Kun says. I can try to salvage this garbage here but it’s not gonna be easy. Sure. I’ll hang my rep on this as my last accomplishment in my long career as a public servant with some options that may or may not pay off.
Or did Missling say. Kun we’ve got something here and it’s good. And the PDD trial makes it even better. We need to put this package together so that people like the new Kun at the FDA and other reg bodies will accept it. We’ve got safety and efficacy in a whole lot of places. We need help building putting this together. Kun says. Yeah. You’ve got a lot. I think it could work. And actually it looks pretty good considering the amount of garbage I’ve seen come through in the past 30 years. Let’s do this!
Let’s hold off on putting out any new data until we’ve hashed this all out.
The Kun card is giving me hope that something positive is going on. Even Kun can’t shine sht. He’s here for something.
So the muzzle comes off on Monday. If no PR Monday morning then we get an updated corporate with the same ole language. Waiting to meet with regulators for guidance, peer review, yada yada.
If that’s his coming out party, people are gonna be pissed, including me. Need a little more transparency here with clearer timelines and objectives. For at least the Alz program.
If no new Alz data like the missing critical pieces, then I can’t help but feel like he’s hiding things.
A good CEO should at least have a sense of shareholder sentiment. I have a feeling Missling knows people are not happy.
Missling is finally making his debut. He has decided it’s time. Can’t say the same sht again after all this criticism. Gotta be new sht.
No more hiding. Kun did what he had to do. I don’t think it’s lipstick on a pig. Kun is at the retirement stage. No way he’s waiting another 3-4 years for maybe an Alz trial to succeed.
After 4 months. If he comes out and says nothing new, he better have body guards at the ASM.
If MJFF is about us, he will hint at it in the new slide deck. Tomorrow possibly?
Let’s hope. Oh crap! That dumb investing strategy again.
I believe they could hold off whoever they want whenever they want with the blank check preferreds regardless of shareholder voting.
Please correct me if I’m wrong on this. I believe 1 share of the preferreds can be converted up to 10 million share or votes. Not sure about the finer details on how shareholders would be affected.
However, from what I can tell, they are safe from any and everyone.
Blank check/carte blanch
That gave Missling a lot of power. Maybe too much.
You would think some type of road show is in order after having met endpoints on a potentially pivotal Alz trial. Something very few companies have done.
It’s been very quiet. Yes, it’s been quiet before but this is quiet period type of quiet. Dare I say it.
Let think about how bad a worse case scenario looks.
-We have to do a real pivotal PM Alz trial
-We are going to do a real pivotal Parkinson’s trial
-We will have done a real pivotal Rett trial
We will probably need to get partner to help pay, facilitate, etc.
Not a bad worse case
Good post. He salvaged what he could and learned a lot from it.
He showed reversal. He showed that our drug actually works.
I’m sure it helped in guiding the Parkinson’s P3 trial.
This is a drug that will eventually get approved. I guess like most things in life it just depends on how much time and patience you have.
That new IR guy must be hearing an earful.
Missling no doubt lost a lot of trust with his most loyal followers. You can only make so many excuses for him.
I can hear Missling now. Why should I say something? What’s that going to change? Let’s just work and give them results when we have to. People are gonna complain regardless.
Yeah true but it’s just what good leaders do that want to keep their shareholders happy. Like others have said. We can’t get rid of him anyway. Maybe he just doesn’t give a Fk. Maybe he says they will thank me later.
At this point everyone is pissed. His MO just breeds more questions and more skepticism. No doubt his credibility is at an all time low. Not a good look.
So at this point you either stick it out with him cuz you believe in the science or you find somewhere else to put your dough.
Me. I’m sticking around. Missling is a d bag but that’s what we’ve got. He’s trying his best and learning as we go. Not great but what can we do? Got a couple big things coming up and I think it will be worth it to watch it play out. I still think he can pull off a big Alz victory considering the current landscape. And Rett is almost here. No sense in giving up on Anavex now.
We need a partner. If anything just to have someone keep Missling in line and to spank him when he’s naughty.
So many screw ups with such promising science. It’s like a feckin bad joke. Just when you think wgt he drops the ball in the red zone. The only question I have right now is whether to bring eggs or tomatoes to the next ASM.
We have money. We still have third party support. We still have some positive analyst coverage. We have Kun. Loads of positive signals. Lots to be optimistic about all for 8 bucks. Hard to see how we go lower especially with the market somewhat recovering.
I’m pissed but I got no where better to go and nothing with the science has changed.
Yep and that’s precisely why Missling brought in Perry and Grimmer. For them to tell us that it’s a no brainer to prescribe Blarcamesine over Leqembi. To point out how much better we are and how less cumbersome it is to just pop a pill.
He was saying. Hello. This is a no brainer and that’s why he said aggressively pursuing an accelerated approval. Telling us. Ha! Did you see what they just approved. Are you kidding me. This is an easy layup.
So he showed us the unconventional odds ratio and the CDR SB to say. Look you want a slower decline? That’s what we have and with some improvement to boot.
So we say. A slowing of decline isn’t good enough. We want more data! Let’s say even if it is a smaller N than we wanted. Is that bad? That some people benefit and some improve and countries save billions and billions and families get an improved QOL for people they love?
No. We need to see the N. We want more people to improve. Otherwise it’s not good enough. Because some people improving is NOT better than none?? Huh. Don’t really get that. Do other regulatory bodies make decisions based on less common sense than I just laid out? I’m thinking no.
When there’s nothing and more nothing and then costly crap with adverse effects, we look like the most beautiful girl in the room wearing a dress of safety and nine inch heels with more safety. But but but it was odds ratio. Only odds ratio. We need more. Ha!!!
TGA needs to get some balls. They see what’s out there and see what has just been approved.
They know we are better, safer and cheaper. No brainer here. Conditional approval with P4.
Or give your people Leqembi. The more we hear about it the worse it sounds. No sense it letting people suffer when there could be some relief now.
Relief for the people and your healthcare system potentially. Or what? Wait another 3 years for us to do another huge trial when you can plainly see we have a positive effect?
You’ve been subsidizing our trials. Might as well be the first to reap the rewards.
Can anyone give a reason not to give conditional approval?
Safe safe and safe. Upstream and safe. Genetic effects documented. A range of other peripheral benefits also seen. Biomarkers out the wazoo. Sigma one research piling up. And oh yeah. Safe.
No sense in waiting. Not pumping. Just common sense and compassion for humanity.
Let’s go. Get some balls. Mother F ers!!
Shouldn’t a phase 2 PDD lead to a phase 3 PDD?
But instead we are getting a phase 3 Parkinson’s.
Why not a phase 3 PDD?
Some were saying they may combine the Alz and PDD together to make a stronger package. Maybe to go for 2 approvals in two indications for the price of one.
Therefore a PDD phase 3 is not needed.
Don’t know if it can happen just trying to figure out why a Parkinson’s P3 is coming before a PDD p3
Kind of mind boggling that it took this long to analyze these FEW patients?
What the hell took so long? It’s been like a year or more.
If this is any indication of when we’ll get additional Alz data, I’m scared to speculate when we’ll get it.
Why do we present data from our PDD trial and then say a Parkinson’s trial is coming?
Where is the PDD phase 3?
-is it because the motor measurements were stronger than the cognitive?
-is it because we really are trying to get both with one stone. No need for a PDD P3 cuz it’s included with our NDA
So, I'm guessing Missling will wait on a partner until he gets clarity on whether or not we need another Alz trial. He's most likely having talks but needs to wait on that crucial detail.
Given what we received today, how much if any does this help our Alz results? Some were speculating that a combined package with PDD and Alz data could make a stronger package.
Wonder if they're waiting to hear from regulators before giving us anymore data. Surely those meetings are happening very soon.
You met. You hire not only Kun but PR along with marketing and sales. You fly down to Austrialia.
But you miss a conference that’s a perfect fit. It seems like your hiding something by being so quiet.
So many mixed signals. What to think. The positive signs outweigh the negative by a lot.
He told us what he’s doing. Getting the secondary measures, biomarkers, etc. Meeting with regulators. Yes, it takes time.
We are like little impatient kids. At least I am. What’s another few months in the whole scheme of things.
I’m trying to have patience and perspective to quote one of our posters. But man it’s hard. A little while longer. The plan is coming together.
Just keep on repeating it. Breathe then vent on the message board. Repeat as needed.
So, an entire quarter with zero accomplishments. Wonder what his PR is gonna be.
Wonder how many analysts will be on the CC. 2 last time. Maybe 1.5
Nothing new to ask. No developments.
So, uh what’s going on? Still excited I guess.
Oh yeah. You hired Kun. That’s great. And…
We’re waiting and ughh working hard and ughh want guidance.
Maybe he’ll bust out the catalysts list again.
Is there a possibility that we still show up at the ADPD conference that is tailor fit for us? Possible but not probable.
Does it look bad that were not there? Most definitely. Pretty messed up especially after all this time not backing up your previous statements.
Time for another round of, Which Scenario is More Plausible?
Scenario 1 - Man, even with Kun, we still can't figure this out. Maybe we should just tell everyone. Nah, let's just pretend like nothing is wrong and during our next CC, we'll just say that we're waiting to hear from regulators. Yeah right, good, don't forget the "I'm excited" line, that always works. I hope Rett can save us. People are gonna be pissed when we have to run another Alz trial. Just say Ariana is doing their KEM magic, precision med thingy.
Scenario 2 - Should we rush to get into this conference? No way, look what happened last time. They're just gonna bash us anyway. We're gonna get the respect we deserve until we have something definitive. Yea, but I'm tired of looking like I don't know what I'm doing. Everyone already thinks that anyway. Let's just do it right. Another month or so and we should have this nailed down. The peer review is ongoing and we have meetings set up. Forget this conference. We'll be forgiven when we show the goods.
Scenario 3 - Who care's about this conference, we are about to show the world what we've got. Kun has put together our PDD OLE with the Alz data to make an undeniable package. We'll put out a video to explain all, go the scheduled meeting with the TGA, wait for Rett, get our voucher, then onto world domination of CNS.
Scenario 4 - Why is that phone ringing again? Isn't our new PR guy on it? Yea, his phone been ringing like crazy. Should we just tell them all that we're about to seal the deal that will get us everything we need? Commercialization, distribution, funding, expertise, etc.. Nah, let them be surprised. You snooze, you lose. You always knew who you wanted to partner with anyway. Good thing you hired for all those positions like marketing, pricing, etc.. Way to think ahead. Yeah, I guess everyone will look back at what we did and will understand why. Exactly! Should we go to that conference? Ha! What for?
So many more scenarios and too little time. Please God, anything but 1 works for me. More likely a combo of the rest.
One thing is for sure, the longer we wait, the more painful it's becoming.
Yes, Missling has a lot to lose.
I don't believe he was rich before and don't think he's rich now with his salary. Let's see what he does with the options. If exercises and then turns around and sells them all, we are in deep doo doo.
Blarc - all great questions that we'll never know the answer too. I'm sure every long here agreed and shared part of your frustration.
Pretty hard not to be angry given all that you said.
"Often the class period of a securities class action case is long. In fact the average is about 1.7 years."
Yes, if they are intentionally hiding and get busted. I think Missling has at least proven he is not a cheat. Working within the allowable rules is different than fraud.
Statistical info seems to have a little less room for misinterpretation and would require blatant fudging.
I'm pretty sure Missling and the gang would have to own up immediately if they found out the numbers didn't match their claims and 3 months would be plenty of time to find out. Otherwise Jin and the gang would be complicit. Not sure that's how he wants to end his career.
Hopefully they're not trying to get away with anything. If they are, they're not doing a very good job of it.
"As I posted before, the best explanation I can think of is that good results depends the pre-specified subgroup analysis of the combined dose arms, which Anavex could believe they have seen enough to expect. This whole KEM analysis could take time to complete, interpret and present in a digestible manner."
Agreed, a definite possibility.
Has there ever been an Alz trial with better results than what we reported? Assuming they are correct although incomplete. I don't believe so.
Has there ever been an Alz company that met primary and secondary endpoints with great safety in a late stage trial that wasn't approved? Not 100 percent on this but I don't think so.
Since they have not retracted or revised their statements with ample time to do so, it tells us they are standing by their claims, and that they are acceptable in regard to standards and protocols.
Since almost 4 months have passes, I think we can say that a bad news surprise is off the table.
That only leaves good news. How good is the question? Even if we need to do another Alz trial with "real" PMA - that is not bad news per se since judging by our share price no one really expects any type of approval. We may even go up on "a real pivotal" trial news.
Rett is coming and all indications tell us to be confident. At least the stats will be in order.
With all our IP and the rest of the trials that are "soon" to be initiated, it's difficult to see how we are not undervalued right now.
Missling reminds me of a child running in 10 different directions that can't focus on which toy he wants to play with. However, given the lack of progress in all other areas, I feel like he's found the right one, like solving a Rubik's Cube. And like a child, he doesn't want to show off until it's finally completed. An almost finished Rubik's cube is not as impressive, especially when you've shown uncompleted progress before and everyone just yawned. Almost isn't good enough when it comes to the cube.
I pray to God that this is happening, since the longer he takes, the more we doubt and the less credibility he and the company have.
And when time is of the essence, you phone a friend - Kun Jin who holds the cube record
Those who have suffered through the growing pains of the the past 8+ years are clearly and rightfully frustrated. Do I curse Missling and ask for his head in private with family and friends who have invested? You bet I do.
Am I angry and moody most days about progress? Oh yeah
Then I think about the new investor and how lucky they are to be walking into this company at this particular time. They are coming into a company that is firing on all cylinders.
Viewing the situation from their perspective helps control my fits of rage.
You may be on to something.
https://www.dementia.org.au/about-dementia/types-of-dementia/childhood-dementia
Missling is all about learning about what 2-73 can do. Looking at the wide range of symptoms associated with childhood dementia, 2-73 would be a good fit.
The larger picture could be an umbrella type drug that can alleviate a multitude of childhood rare disease ailments. Endgame?
Thanks. Yep, you don't take a 23 hour flight just for that. Not that it isn't important, but he could have zoomed or sent someone else.
You can zoom any meeting, even court appearances. Missling chose to go down in person because whatever it was, he felt it was important enough for him to physically be there.
Someone mentioned seeing a pic of Missling in Australia? Can someone post it? Was his trip verified?
In our case, it may be that the sum of the parts is needed to tell the whole story.
He can’t keep it a secret for much longer.
Missling and the gang don’t seem to be sitting idle.
You need to click. Submit Resume and then go to Position Applying For. A menu will drop down.
Excuse me? You’re applying for what job. No. That job isn’t real. It’s just a placeholder.
Oh great. You’re applying for that job. We’ll the position really doesn’t start for another 8-12 months. So for now you’ll be pricing and selling our product that we think maybe could have a possible chance of being sold in the next year or two.
Would you like me to set up a interview.
What will I be doing all day.
Mostly just making up, what if scenarios with all the other people in our almost commercialization department.
Not sure how many of these jobs are new. It’s been a while since I’ve looked on their drop down menu for employment opportunities.
Vice President, Marketing
Director, Pricing
Director, Sales
Senior Director, Medical Affairs - In the simplest terms, medical affairs support the commercial side of the business, including sales and marketing.
VP, Quality Assurance is still there, although I remember someone saying that was filled.
Maybe they are working towards commercialization.
Yes. Probably
He still needed to take a look under the hood to be sure.
Kun Jin's hiring and choosing to stay is not only great because of what he brings to the company but also what it says indirectly.
It says, Missling's statements about meeting endpoints are valid. Robust, Statistically Significant and Clinically Meaningful Absolute Improvement in Cognitive Function as Measured by ADAS-Cog and ADCS-ADL
It says, the data is valid and no manipulation or fudging occurred. It says the Odds Ratio was in the SAP although it may not have been the best presentation of the results. Kun will fix that.
It says, Missling really is pursuing an accelerated approval and that it IS possible to achieve. Otherwise, Jin would have been like. Dude, why did you say that? I guess he could have but not likely. Missling has said the same in every presentation after the CTAD.
It says, he is confident enough to have this represent the finale to his career.
It says the Excellence data will be in good hands and the statistical aspects of our NDA will be proper.
It says Missling knows he needs help and is willing to seek the right people. Look at our SAB. He's always known that he needs to surround himself with the best.
I believe Kun is looking at the PDD OLE before its release, hence the delay. Hopefully he will also, as others have suggested, try to tie this in with our Alz data to make a more convincing package. I'm not smart enough to figure out how or even if that can work.
I must admit, my frustration level with Missling was at an all time high before the Kun hire. It's still high now, but I feel better knowing the above.
Kun has connections at the FDA. Those don't go away because Billy did. I wonder if he has connections to his counterparts at the EMA and TGA. I'm betting he does in some capacity, even name recognition matters to a degree.
How may BPs are our new PR guy networking with? How many feel threatened by our CNS Platform? How many have dwindling CNS divisions that need innovation? How many want a piece?
Kun was part of the status quo that was indirectly supporting the amyloid hypothesis. He just broke away.
It takes balls to come to a tiny, virtually unknown biotech with a new paradigm shifting MOA.
Soooon!!
I'm not worried about dilution at any price. It's just the cost of doing business. Missling has shown to be savvy in this department. I'm confident he'll be prepared way in advance.
Plus, a lot can happen at any time to change our circumstances, which I'm betting on.
Once we show results that backup Misslings statements. Our MC should fly. Biogen’s MC went up billions upon their release.
Missling released more PDD data months after the initial results. That was part of our bump to $30.
I expect a release soon. Hopefully that video talk wasn’t fake news. No need to keep it all for the peer review. God knows how long that will take.
Maybe a PR about a meeting with regulators. We have a great drug but our company has a credibility problem. Yes BIO, Missling is to blame. Don’t think he’s going anywhere anytime soon.
Learning while you go, is difficult when we should be going full throttle. However his good qualities help to balance out my love/hate relationship with him.
He has a chance to redeem himself. Getting Kun on board is a start but it’s what he produces that counts the most. Credible results presented in a way that tells the world, WGT will launch us.
I think that’s coming. No need to keep it a secret. Shareholders are mad and I’m sure he’s hearing about it. I’m sure he’s a little embarrassed as well with how he handled it whole release.
Getting Kun, the regulatory hire and the PR guy with all great resumes speaks loudly to our direction and to what they saw when they got a chance to look under the hood. It says growth, confidence and preparedness.
We are flush with cash and have more if we need it. It has been quiet. Too quiet. Kind of strange that we had that news piece for Parkinson’s P3 when that wasn’t even on our list of catalysts.
Trofinetide got their first but it’s how you finish that counts. Let’s see how the Excellence trial turns out.
For now, it’s all about Alz. Time for Klamer and Toutain to show us what their worth. Sigma 1 is getting more and more recognition as a potential target for many diseases. There’s no doubt that BPs will start diving in. We are so far ahead and Missling was smart to trademark the Sigmceptor platform.
Are we a target for a buyout. Yes of course. But Missling had the foresight to get the blank check preferreds. With no debt and a great cash position, it seems we are going into negotiations with some strength. Can’t bully us.
Things are moving excruciatingly slow just like they’ve always been. Hoping that we can show some strength in this market downturn that we’re in. I think he knows he needs to release more data very soon or he’ll have people with pitchforks at the office. I may even be one of them.
KGT
Kun’s Got This
Yes, they have the data and yes it will be released soon.
Missling just told everyone. You think we’re sloppy. Maybe you were right.
But not anymore pal!
We’re serious about our data. Better late than never.
It’s gonna be buttoned up real good. No holes this time. Because we heard you. Something needed to be fixed in our company. We had a weakness that we just turned into a strength.
Let’s FN Go!
You buy now or you regret lata. I think that’s was part of his message.