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Yep 9 months of no developments. Just analysis and more analysis. I pray it pays off.
WTF is everyone else doing? Hopefully it’s all hands on deck writing NDAs, establishing potential partnerships, etc.
Setting up infrastructure so trials can get started right when they’re ready.
The SP is depressing and gives the illusion that nothing is happening behind the scenes. Just frustrating not knowing what it is.
I hope Missling wasn’t diluting into this drop.
I know Missling said he would wait until Alz approval for a deal but why not now?
Especially if a company is willing to set up milestone contingencies and give us a fair deal. Having that type of infrastructure and political muscle can go a long way.
Seems that right now, Anavex May finally have a clear recipe/dose/administration/etc for treating rare diseases and larger CNS indications.
With a large pharma partner we’d be able to run multiple trials at the same time rather than moving a a snails pace like we have been.
Get the Parkinson’s, PDD, Fragile X, undisclosed hullabaloo all out asap. If we need a larger P3 or P4, they can help with that too. Funding, recruitment, bigger and better CROs etc.
I’m sure a BP like Sanofi and others looking to expand/survive by acquisition and partnering would love to strike a deal with a company that seems to have so much breadth in the pipe. A fair deal for all.
We have the blank check preferreds so no need to be scared of a takeover. It just makes too much sense. That’s probably why it’s not happening.
A part of me feels like one is in the works. A new chairman, more statistical muscle, clear biomarkers with a path to approval. Not time for slow and methodical. That we done already. Time to hit the gas
There are many ways to value or pipeline based on current and future potential. BPs have super deep pockets.
Missling even mentioned solicitations for Rett even before seeing the Excellence results. Do we really think solicitations aren’t being made for Alz? Showing improvement in patients and being better than the soc is every way.
We have analyzed the living crap out of our MOA and know more about it than necessary. The heavy lifting is done. No more wasting time.
Get the damn partner and light this bich up! Let’s FN go!!
Would Missling be so dumb as to release a failed Rett trial during Rett month? I don't think so, but have been wrong before.
If the trial was a failure, the results would have been out by now since timely reporting is required. Are they massaging the data? Maybe but hopefully Kun will bring some integrity behind the results.
This nonstop bleeding is ridiculous!!
Bring Alz overseas! Please! I know he said he could establish a higher price here in the US, but who gives a crap. Just get something approved. If the FDA says no, other countries may follow suit but if other countries say yes, it may force the FDA's hand.
Let's FN go! Don't be penny wise and dollar foolish. Come on man!!
https://pubmed.ncbi.nlm.nih.gov/19751920/#:~:text=Disease%20modification%20can%20be%20defined,on%20the%20course%20of%20AD.
Looks like we fit the definition for disease modifying.
Any thoughts?
Sad but with all the holes in our data releases, he doesn’t seem very good at dotting I s or crossing T s.
Bring on Rett. Stop the bleeding. Be more transparent.
Please!!!!!
The FDA won’t be able to ignore us if we have a significant amount of ever before seen improvers which it seems that we do.
Also, I was thinking of the type of direct access Kun has with his old friends at the FDA getting an inside scoop.
After 27 years you make a lot of friends. The guy that replaces him probably even worked under him for a while. Maybe even lunch buddies.
Couple of texts. This is what we’re looking at here. What else do we need to get it over the finish line? Lunch next week? The usual spot? Ok.
Kun was a decision maker. Not just some fda dude. Hard to believe he doesn’t have contacts or access.
It may be eye opening when we see how many actually improved. If that number is big, exceptions will be made if we need them.
For now, let’s see the damn Rett! Prove the MOA and let’s get our rare disease franchise moving.
Wonder if Kun had a hand in writing this guidance.
Quite possible
It seems that this extra data will make the peer review that much longer since amendments need to made to the article. I’d imagine the new info would need to be reviewed as well.
The number of improvers will help seal the deal for AA. Seems that many here believe the number to be quite high.
And we keep the amyloid crowd happy. Big plus since their influence runs deep.
A safer easier way to reduce amyloid has a nice ring.
I’m assuming as many here are that the company will wait for Rett approval before filing for Alz.
Repurposed drug argument.
What’s your opinion on that?
Is the voucher really worth the delay? IMO I don’t think so. It could be another year before they file for Alz if they are waiting for Rett approval first.
Does AA disqualify them for the voucher or is it a work around since it technically is not a full approval?
Others have mentioned that the FDA was not mentioned specifically in the PR and just regulatory authorities. My hope is that we file in other countries first or simultaneously. Seems like a no brainer.
Be a wasted opportunity if they didn’t. Wasted time and potential revenue loss.
Key Words
Objective Evidence
Sorry to jump on the bashing train here but Missling has been given too many chances to get things right.
Does he just act unilaterally? And all the employees are like. He just did what?
He’s brought us this far and the science seems solid but man he has a lot of screwups. All have been named here multiple times.
He may be a financial whiz but is lacking in leadership skills. Make him the CFO instead. If he doesn’t get these next huge things right, he’s gotta go.
We need someone that can actually take us over the goal line. And with someone common sense. Some of the things he’s done has so many of us scratching our heads.
Hopefully he’s the quarterback that has thrown so many interceptions but wins the game in the end with a magical play.
Thinking the chairman replacement wasn't his doing. He's too controlling to give that up voluntarily
Oversight and accountability was badly needed.
Needed Kun to perform corrective actions. With that said Kun wouldn’t have stayed if the data didn’t entice him.
Any thoughts as to why they didn’t release the number of super responders initially?
That would have made a splash on its own and then go on to do the extra analysis they are doing now.
Alzheimer’s Reversed makes a good headline. Missed opportunity?
If it happens that Missling hid the ADL because it wasn't good. His credibility will be shot even more and AF and the FUD brigade can be like. See he's full of bs trying to pass off failed trials as successes
There needs to be a very good reason as to why he withheld it and why they used odds ratio.
People will crunch the numbers the traditional way if not presented and if it failed using the standard endpoints then the biomarkers may do little to save them from criticism.
Hopefully the FDA will view it differently if that is the case
What’s a good reason for not providing those numbers along with the odds ratio?
Missling knew it would cause a lot of controversy and decided to leave it out anyway.
Just doesn’t make much sense. If the number needed more context, he could have and should have said that.
Wouldn’t this contradict Missling’s statement about the possibility of the OLE being the confirmatory trial?
Doesn’t this statement imply the possibility and intention of applying for AA?
Were Missling’s statements about Rett partnerships, OLE being confirmatory, sales and marketing in motion a big fat signal telling us and the market that our Excellence trial was a big success?
Be pretty dumb to mention those things if results were ambiguous. By now he knows.
Agreed.
Our first nda can't be Alz. The powers that be will never let that happen especially with an unproven drug from a no name company. Missling is smart. Prove the MOA with Rett first.
It will help pave the way and smooth the rough road.
A lot riding on this Rett trial.
I just pray Missling doesn’t say, we’re still analyzing the data.
Why can’t they just try to negotiate a higher price?
Someone posted that Missling said they were planning on applying to the FDA for Alz first because of pricing. How does that make sense?
You have the first effective Alz pill and you think the Aussies are going to short change you a few bucks a pill?
IMO. It was a mistake to not apply in Australia, Europe, etc.
And he still would have preserved the voucher.
How about some transparency and clear statements about where we are in our progress? That would be great and not very hard to do and would keep us from making up imaginary scenarios about where we are headed. Instead many here including myself are confused and frustrated.
How about something like this which is pretty simple and straightforward.
We released our Alz data and we know it is not "standard". We left out some numbers since the data needs context for you to fully appreciate it. We presented it in this way because we thought it was the best way to capture our success in the limited time we had.
We are diligently working on it and are including additional biomarkers so you can fully understand what we have and will be bringing to the FDA in hopes of an Accelerated Approval. This will take some time. The peer review paper is in progress and there are some things we need to save for that, however we will present everything else that we can.
The Rett data is coming out next month and we want to file the NDA for that before the Alz in order to secure the voucher. We want to use this money to expedite our newly planned trials and to find our commercialization plans. The Alz NDA will be filed shortly afterwards.
If he said something like this no one would have any questions and it would help us be a little more patient.
Yea. I like my hand to be held. I like straightforward talk. Unfortunately we don’t have this and likely won’t get it any time soon. So we just wait and wait some more. I am confident in our direction however unclear it is and will see it to completion.
And yes, I will be mad and complaining along the way with many of you here.
I think we may possibly almost Have This but am not sure. Ha!!
What a disappointment to not show up at the AAIC. All these excuses here are BS and fantastical.
https://advantx.org/science/sigma/
They’re way behind us. Another company focused on Sigma 1. Sigma 2 as well.
The call it the SIGMA platform.
We don’t need full data, we just need some of the big numbers we’ve been waiting for.
The other smaller less significant biomarker data can be saved for the peer review or reg submission.
Right now especially Missling has himself created this credibility issue with the company and its data.
He needs to right the ship and back up his statements with some facts. His words do not carry weight on their own and have not for quite some time.
AAIC is the perfect place to make a splash. With enough data to bring back some of the lost credibility. Investor confidence continues to dwindle regardless of low grade PRs.
Not showing at the AAIC sends another message of a slow stalling company who is hoping their Rett data will save the day.
Frustration continues to build. SP continues to do nothing. Confidence and credibility continue to drop. Catalysts/trials continue to be on hold.
Yeah a lot going on behind the scenes but progress needs to shown with facts and real substantial value creating steps.
Let’s go Tuesday Newsday.
The interviewer didn’t ask the most glaring question on everyone’s mind. When are we going to see more/full Alz data?
I bet he was told not to ask that because a PR is coming.
AAIC. No reason not to be there.
Give us the appetizer teaser and then the main course at the conference. The way he did is last time for PDD.
They did not wait for this review to move forward.
They proceeded to approval and released full data way before.
The odds of Missling waiting for a peer review before dropping the MOAB are pretty low to nil. Letting someone else’s timeline handcuff your progress would be the epitome of dumb.
Let’s see if this has any affect of Acadia’s SP. Probably not.
Does anyone know how many days before in the past AAICs Missling PRd their appearance?
I searched but couldn’t find a PR announcing a late breaking or other presentation.
I also have not seen any other companies that have PRd a late breaking for this year yet.
It’s been long enough. Can’t see why they wouldn’t be there. It may still be early to announce.
Giving us a teaser with some solid biomarker data before full results at the AAIC would be a good move.
Unlikely that we don’t get full results before the Rett topline. That’d be seen as being suspect by some.
Missling’s course correction whether his doing or not will help Anavex emerge as a stronger company.
He or his board new that Missling could no longer function as a one man show. He was in over his head juggling so many different roles which I believe led him to become a micromanager who is trying to lead instead of a leader who delegates to a trusted team.
The increases in hiring including the ultimate hire (Kun) followed by a new chairman will allow him to focus on his other core competencies in finance, negotiations, partnerships, etc. His last interview with the Asian company showed a maturation as he spoke about things that he may have thought but never really verbalized. He spoke about relationships, trust and team.
After the fumble at CTAD, he realized he was in over his head and made the right leadership decision in stepping back a little doing what great leaders do which is to hand over responsibilities to those who are smarter and more capable.
I believe they took a step back, took a deep breath, reorganized and tightened up the path forward. Yes it’s slow and frustrating, but it will all be worth it.
A necessary step for the next phase of growth.
Do we think Biogen is just going to let us steam roll their Alzheimer’s program?
Wonder what they’re planning? I guess the amyloid lobby will be put to the test.
Maybe Missling knows we need muscle and a partner will come on beforehand. It’s easy to say no in order to suppress the little guy, but not one with a big brother and a powerful lobby as well.
When we see what’s at stake here, you bet you’re axx that we’re in for a fight. That’s why I was perplexed to hear that Missling was going to the fda first.
Didn’t we want to avoid a corrupt system that may be in the hands of BP? It’s disappointing to hear that we won’t go to the TGA first after all their support.
I thought having the leverage of an approval elsewhere would be a nice card to have.
I guess Missling thinks our data is strong enough to overcome whatever obstacle that may be in our way.
Didn’t he present some of the PDD data before the AAIC which got us the bump into the 30s?
Maybe he’ll do it again.
Be great if Missling exercised those options and kept them.
That would be a big statement.
Very big.
I think it's pretty clear now that Kun came because of what he saw in our data and the value that could be added with his help. He knows exactly what was been approved and what has been rejected and why.
Not bad to have him leading the charge on multiple fronts.
Hey Kun, can I say this in our next PR.
Yes, you can. And put it right on top in bold.
Any thoughts as to why Missling wouldn't apply to the TGA, EMA, FDA, etc. simultaneously?
I know it was reported that they will go to the FDA before others because the US pays more. That seems like a strange reason as our pill isn't that expensive as it is, and I don't think other countries would complain about paying a premium for a drug that works considering their other choices.
Seems like wasted time in regard to ROW.
Any comments on peer review status?
This along with biomarkers, OLE data should make for a convincing submission.
Hopefully this can be included in their package.
Improvement is a big word
Thanks, Is this quote for Alz? If so, that is surprising.
Surprising that they are not saying approval will be sought at the same time from all regulatory agencies. So they are waiting on US decision first?
"US will be before seeking Oz approval, reason is better pricing."