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Investor, did they ever specify the dosages given to each group?
Yes I do.
After analysis, reports, application, meeting , etc. You’re talking a long time.
More likely for Rett in UK.
Maybe they got some info from Spain in regard to PDD. Not too familiar with the AEMPS.
Do you think it’s too early for them to start hiring for sales and marketing?
Presumptuous?
Or approval of adult Rett. That should be the number one priority. Apply anywhere and everywhere for anything possible.
Same goes for PDD. Ya never know what you can get until you try.
What do you think will happen afterwards?
Move on to plan phase 3?
Or apply for an expedited path overseas on the strength of the OLE?
Other?
Was always confusing to me why they didn’t move fast on unprecedented data.
Or the UK - the one that OKd them to move to a phase 3
Wondering if they move at a quicker pace.
Was also thinking how our Alz trial is with the TGA - PA there would put some pressure on the fda.
That’s only if the TGA has the balls to move first.
Why didn’t Missling start another Alz trial if an additional one could be required?
Arrogance? Bad advice? Money?
Why do you suppose the PDD phase 3 is no longer in our Catalysts to Drive Value?
You’d think that’d be a priority considering our results. Pretty darn long to plan a trial. 2023? What??
No one knows of our previous Alz data, which was not much, although exciting.
The general population doesn’t really care about the correlation seen with our PDD data.
We have a decent size trial finishing with a new MOA that is not understood by many.
So, I’m guessing we will not get the run up into results that is hoped for.
Smart money is in no rush to get in as they know they have time. We are on the radar but they aren’t ready to pull the trigger.
An NDA for Rett will do wonders. Let’s FN ago!!
What is he doing about our PDD data? Yes, he is planning the pivotal phase 3, but in the interim wouldn’t you apply overseas to see if you can get any type of expedition.
Why do you think Missling didn’t run or start another Alz trial?
Many wasted years if they are asked to do another.
“AVXL's share price is following the XBI”
Yes, that’s why I’m frustrated. We should be breaking away to the upside.
Potentially pivotal Alz read out. No excitement or anticipation of results reflected in SP.
Stay sig Rett results with QOL improvements ignored after data release botched.
All the other stuff we accomplished should have been SP launching catalysts. Crappy PR team needs to get our word out. What the heck are they doing?
Please don’t say this is part of Missling’s strategy.
We have had some results that should have been shouted from the mountains, instead we are here with self inflicted wounds and a lagging SP with no excitement which is also self-inflicted.
No articles of note. No coverage. Just another presentation. Damn. Starting to sound and feel like many others here.
Build some excitement for Pete’s sake!! Yeah but we don’t want to attract attention. Take over. Blah blah. We’ve been saying that for years.
We should be approaching the launch pad!! WTF!!
I want my FN bike!!
Wondering if Missling will be there tomorrow.
Hope it’s not a crappy overview. We are past that with Needham.
Maybe shed some light on where we are in regard to fda talks and other reg bodies.
Hopefully they pump up our Alz program and communicate how we are set up for success by the evidence thus far.
Bar is very low compared to what we’ve been reporting in our other trials.
We don’t need cognitive improvement. We just need stabilization or even less decline compared to soc.
We’ve been using the term “reverse” for years and we have seen this with 2-73 on multiple fronts.
With so many amazing anecdotal improvements in our tiny 2a, we will surely see many many more in this trial.
Once we get the PR for trial completion, Missling’s PR team needs to be proactive in spreading the word.
These two conferences definitely overlap. The other conference was very informative. Hope this will be similar, although I don’t think Missling is attending. We’ll see.
Hopefully coverage is coming.
They did their HW the first time. I would think it’s relatively the same pool of informed investors, so it could be just as in depth.
Yes we are investors in a young biotech that should be trading at much higher levels.
Missling does not need to hold our hands but he is at the mercy of the shareholders, at least he should be.
I don’t think anyone here, you included was satisfied with the mishandling of the presentation of our Rett data.
Yes he marches forward but that does not mean we should just accept his faults. Timelines matter, transparency matters, shareholder equity matters. Sitting quiet and just accepting the status quo as “investors” is how many companies get ruined.
Will that or could that ever happen?
Doesn’t seem likely.
I remember when we got that new PR company that was proactive for about 5 minutes throwing out positive tweets.
Now Jack sht. Get our message out. Revolutionizing CNS treatment.
Yes, pump our message. He’s made attempts at branding, changed the site, etc. All good but now spread the news.
Amazing that we are so close to a potentially pivotal Alz read out and there is very little interest.
Other companies just mention the world Alzheimer’s and their stock goes up in anticipation of anything positive.
I’m wondering if the botched Rett results release cast a shadow over us.
That probably as something to do with the lack of excitement. However what we really need to do is to generate some buzz. What’s wrong with talking up your company especially when you have results to back it up?
Missling just doesn’t have the type of magnetic enthusiasm that is needed.
Unfortunately without the buzz, we get few new investors and more limbo.
What’s it gonna take to get some new coverage initiated??
Don’t get it.
This languishing share price really sucks.
When does an Alz run up start in anticipation of results? September?
I’m assuming the clinical trial report is nearly finished. Hopefully we see some news on that front.
Can’t see anything else taking us out of this range. How about initiating the Fragile x trial or any trial for that matter.
Too quiet. Makes us feel like there is no progress being made.
Let’s FN go!
Yes. Good points.
Wonder if this was measured in the other trials and just not reported. Don’t think this was just an aha moment.
I’m guessing the cause effect, dose response relationship between L-AAA and/or other measures taken could also strengthen the argument for our sigma 1 biomarker as well.
Why do you think he moves so slowly? Serious question
I’m sure it’s on purpose. Doesn’t make much logical sense though.
Bet it has some to do with trying micromanage everything.
Is it too early for a Rett partner in Asia?
Wouldn’t it be imperative for Missling to get the adult Rett improved since it would favor a single pivotal Alz trial?
I believe you have posted on this a couple times.
Seems like that would be the priority over a voucher and/or anything else.
Cantor event doesn't seem to be public. Also, Missling doesn't seem to be attending. Otherwise his name would have been mentioned, since a CEOs attendance is important.
Hopefully someone reiterates that we are moving full steam ahead with trying to get access/approval for Rett adults.
Be nice to get an initiation date for Fragile X.
I don't expect an upgrade from them because of this unless there is a progress update along with other news on our rare disease trials.
A lot of events converging for the second half of this year. Should make it quite explosive. Just need one trigger to set it off.
If PDD OLE turns out to be great. Wonder if that would help in getting some type of early approval. Although unblinded it would still be confirmatory.
Everything pointed to success in Rett and it was, then everything pointed to success in PDD and it was, it also pointed to success in the 2nd Rett and we all know what happened.
Can’t count chickens yet, but it’s all pointing that way for Alz too.
MOA is becoming clearer, Sigma 1 is getting more recognition and we have the Sigma 1 discover platform!
On a side note, did anyone listen to the sigma 1 talk/presentation from the conference? Not sure it was publicly available.
Interesting. Any idea how long she was with the company?
Any clue as to when Fragile X will be initiated?
US trial?
I’m assuming it’s the first half of the year since other catalysts have a 2H in the corporate presentation but not this one among others.
Be nice to get our turn at a FOMO price run like the others did.
The Needham conference was interesting since they went right into questions without the same old company overview.
This means the analyst did their HW and expected listeners to have done the same as well. Their target audience was one that should have been well informed prior. Current investors, soon to be investors, smart money that had questions before investing, etc.
I'd be surprised as I always am, if they don't don't cover us soooon.
They knew our story, were familiar with the science and asked the right questions - ones of concern, progress, near term revenue, marketing, partnerships, other reg bodies, other drugs in our pipe, plan going forward, etc.. Very good questions. Ones that many of us had. I for one was satisfied with the transparency.
I guess Missling is not transparent naturally but can be if asked. And he definitely is at the ASMs.
Different type of conference. Cut to the chase. Volume increased right after. Let them position then cover. IMO
Will Trofinetide’s results be dismissed? I guess we’ll see how much lobbying power they have.
https://www.propharmagroup.com/blog/a-guide-to-the-clinical-study-report/
Guide to the Clinical Study Report
Only comparing the trial size to those of Rett and PDD and considering how long it took to get those.
Thanks. I know many others have also said the same.
Just wondering how Missling could be so confident in his timeline.
Is it the same ole miss timeline Missling or did he learn from his mistakes? The Alz data is big and people will be watching to see if his word is bond.
Someone had posted that the CRO's could be gathering and crunching data as they receive it from the Alzheimer's trial.
Does anyone know if this is possible?
If so, why wasn't it done for the other trials? Assuming it wasn't because of the amount of time it took to report.
I don't see any other way they could report TLD this year if they don't.
I liked the way Missling continues to clarify the reason for using the RSBQ-AUC, although sometimes muddy. His English accent and the scientific language used, which is necessary makes it difficult for the general investor to understand.
By doing this, he is indirectly attacking Trofinetide, possibly on purpose.
When asked about the RSBQ scores for the Avatar trial, Missling was pretty much like, "Who gives a shat, it's meaningless". Then he went on to say how some patients could show a 300% improvement and not have it mean anything.
Having said that, I wonder if the FDA will view Trofineitde's results the same way. If the RSBQ is really that varied, isn't predictive and shows little meaning on its own, why would the FDA give them an approval?
I guess it could have some parallels to the amyloid hypothesis if it does manage to squeak through. If the FDA is current on science, which it seems like it is based on the guidance Missling received, then it would seem Trofinetide's results would be dismissed.
Yes. You are right. Meant application for PA or other from UK, TGA, etc.
Not sure if meeting is required before those types of applications.
Probably are as well.