If plaintiff hasn't had discovery yet, the Avatar SAP may yet become an issue. Hopefully it won't, and won't even get that far.

The chances of further endpoint creativity has dropped with the legal complaint, the pending FDA guidance, and the hiring of Jin. Missling very likely learns from mistakes.

It's interesting that the Avatar SPA has not come up in the complaints or MTDs. Was discovery served yet?

No, I suspect this complaint won't survive.

Missling was a lawsuit waiting to happen. The Board made some good moves, though a little late.

The RSBQ AUC, the ADL OR, the GABA and glutamate claims. It's good that Jin is now handling endpoint and results reporting. Missling was getting over his skis and ended up even attracting a lawsuit. The BOD took some smart actions.

That's a pumping fool.

He's always talked a 'good game', and a bit of a bull s'er. BS walks with regulators. But we've got a good case if they're feeling particularly aggressive and receptive with AD.

We've clearly had some problematic CROs, though of course that doesn't excuse management, who selects and manages them. And we've augmented our inhouse biostat function, so that should speed things up. We'll see with the AD OLE and the schizo POC.

Speculating on a biotech you don't understand, risking too much and compounding it with leverage by gambling with instruments intended for hedging, blaming hidden conspirators when you lose your money. Telling yourself I'm a stock investor. Warren Buffet, watch out.

Interesting to note: at minute 46 the Longeveron rep says his company did just that in their small POC trial: they detected and publicly showed a potential correlation of brain (hippocampal) volume improvement of their drug to cognitive benefit (MOCA and MMSE).

Thanks for posting. 9 minutes in, Missling points out that correlation of AB reduction to cognition response has not yet been "described" (studied and disclosed), saying that it may be because there is none.

We too, however, have not provided cognition correlations for our brain volume,mAB ratio, etc biomarker results (this will cause whining from who don't read). This is one of several things the paper needs to "describe", along with S1 status correlation. Missling is implying saying here that they will be for our trial, and reviewed in future scientific talks. Let's see, looking forward to them.

It's a small, 'sophisticated' trial. (Our AD phase 2a with 2-73 was as well.) The 2021 phase 1 only had a SAD cohort, hence the MAD cohort (the 'Part A') in this trial, and with sick patients. The company was also involved in a multi-sponsor schizo ERP/EEG study and is applying what they learned about the condition.

Yes. The schizo trial is a POC study and so won't be registrational. This is the very start of 3-71 development. Small n is appropriate.

The hidden conspirators' greed, not yours. Got it.

The price drop conspiracy is so obvious. It's rigged. Did you see that conspiracy to pop the price yesterday? They're so mean. I'm telling Mom

You have a poor understanding of "news".

Yes. Given the FDA's move on MABs, the EMA no doubt feels inclined to approve some novel AD therapy(s). It is not immune to political pressure, which along with scientific concerns, is why it has resisted expensive MAB therapies.

And foolish pumping.

The new hires are likely paying off. They were smart.

You mean 'forgone.'

All that 'PM wonderfulness' in the paper, yet Avatar and Excellence yield disappointing results. Not a good look. Missling. We're not hearing anything about Rett since the Excellence disappointment, and it's not surprising. It's likely on the back burner. Hopefully FX is starting soon; it's been 3 years now. Same with PD and the "undisclosed indication".

This is Doc's biggest criticism of Missling, who apparently led the design of all the trials up through 2022.

The FDA provides "guidance" on trial design, when sought. The strongest and most formal guidance is from an SPA, which must be requested. However, even an SPA does not guarantee that the FDA will approve a drug upon successful trial completion. The regulator makes that very clear.

The company expanded Excellence (and apparently under FDA guidance), but it still failed to meet its endpoints. The company said they'll do another, bigger Rett trial. This will likely not happen soon; see the time it's taking us to do another Parkinson's trial.

We should be hearing about this and FX before year end, and OLE data.

They've caught on to your nonsense, tarot.

Read what the company wrote again. Take a moment.

That's one of a couple saving graces for us, for US approval; hopefully it makes the final version. And hopefully the EMA also shares that view.

The donanemab large phase 3, which like our trial was for MCI and early stage AD patients, met its primary and secondary endpoints. These included ADCS-ADL, which contradicts our claim about that endpoint's poor utility and irrelevance for the (same) study population. Your point that the FDA's CRL concerned safety, not efficacy, is correct.

Survivorship bias is a possibility, and takes analysis to identify or rule out. Given our dropout rate, and since this bias can be difficult to determine, the company's definitive statement is hopefully substantiated. A summary of the bias analysis should be in the paper. A good reviewer would require it, as our dropout rate was much higher than the lecan and adu trials.

Investors operate under imperfect information, and things like EMA approval rates are helpful. They shouldn't be treated as any more or any less. If that conditional rate was 99%, our prospects would be reasonably higher. If it was 50%, it would be reasonably lower. Around 80% is the best initial approximation; you then go from there. "Go from there", people should note, doesn't mean you factor in desires or prejudices. It means considering the relevant specifics of the drug in question (starting with the drug's intended indication, its trial designs and results, alternative treatments...).

Don't invest blindly. Look into the recent EMA approvals; you'll find few surprises. I only found one. (And mentioned it here last year.)

To assess the risk, include not only the average MAA approval rate, which is recently >80% upon submission, but also other factors. (Start with indication size, trial size(s), relevant biomarker(s), all costs, all key endpoint results, political environment, etc.) I think upon submission we have >50% chance with the EMA.

Zoom out. Note what equity markets in a dynamic developed economy do over time.

Foolish to watch pots and navel-gaze and cry. Be investors, folks.

When the price goes down, the panic, conspiracies, and other silliness explode. You bought equity in a risky development stage biotech, not a magical lottery ticket that someone's trying to steal. Be an investor. Also, be a grown up.

Biotech's not for everyone.

The Prilenia results are disappointing. But the EMA appears to be open to a submission, since HD is basically untreated and the drug would be cheap and easy. And they can always say no once they take a hard look. It's telling that the company is holding off on the FDA.

While there are certainly parallels with Anavex, our results are better. Not a homerun, but nevertheless. Though we too are holding off on the FDA.

Our MAA submission should be coming soon.

You're not "describing" anything "ahead of time." You know that, right?

Hedge funds aren't ruining you.

They don't know, nor do you. No need for dramatics, take a moment.
The paper is now conspicuously overdue. Hopefully it's not an indication of difficulties with any journal. The PD and FX trial starts are also taking far longer than expected, which is disappointing. Let's see what Sept brings. I'm pretty confident the AD MAA package can be delivered in early Q4, as Missling has recently projected.

Easy There With The Valid Proclamations, Ima

It's a medical device news site. They don't have insight into our drug or prospects. If you read with any care, there is a section that is factually false (follow the embedded link, too):

"The COVID-19 Effect and Neuropsychiatric Pathologies
Current research by Anavex [link] into the neuropsychiatric symptoms following acute COVID-19 infection, particularly in older adults, is revealing significant insights into the pandemic’s long-term impact on mental health..."

Take a break.

It's possible, though the company has not mentioned the UK.

Missling said he expects our MAA for AD to be submitted by Q4. There may have been some hiccups in the preparation, but that happens. Once done, the question will be if the company pursues any other regulators in the meantime for AD. It would be good to see the FDA and/or TGA, showing our overall confidence in approval prospects. We'll see.