Yes, sounds like an unhealthy addiction.

Yey! I made it in the top 25!

Why careful? Does anyone take him seriously?

Investor conferences are almost always a nothing burger. I would not anticipate any news.

You should reconsider investing in biotechs with such views. The Rett trial failed, and no regulator would approve it anywhere with these outcomes. They may go for another trial, but this would add a minimum of five years to the timeline, and likely that trial would fail as well. The Rett programme is dead for 2-73. The quicker people realise that, the better. Everything Anavex now has is the EMA submission, which in my view was speculative and unrealistic. However, this has less than 1% chance of approval with the data we have seen, imo. But it seems it works for Missling in terms of keeping the mcap that high.

More like a unicorn...

Glad, we are in the same team, I bought all my shares at the ATL and sold them all at ATH.

Not apples to apples; LS-mean and ad-hoc analysis for Anavex.

My assessment is less than 1% probability of approval for any indication in the next 5 years. The EMA PRs are a joke, if not an effort to minimize the damage from the fail in Rett and put the stock into life support for a couple more years. Even if they go ahead with another trial in Rett, we are looking for many years until approval if everything goes as planned. I am surprised that the mcap is still that high, to be honest. I think it is time to start selling calls now.

You are kidding, right?

Is not that a miracle? I doubt anyone else would have managed to survive that long, but his strategy is impressive.

On (1), hard to say if they lie or not. The facts are that some metrics in the original presentation were missing, some stats were incorrectly computed, and the follow-up PR referred to different metrics. This adds risks for both the long and the short thesis that I am not personally willing to take. On (2), I do not believe that the agency has reviewed any of their efficacy data at this stage. Overall, I am more in favour of the Investor's views than yours, but I also believe that Investor lies in claiming he has a long stake here.

Irrelevant to what I said.

"Powerful science?"

Had a quick read of the PR and the underlying statistics appear as flawed as any other statistical analysis they have presented to us in the last few years. Unless the pathways are pre-specified, the differences in the two groups could just be an outcome of multiple comparisons. By comparing the differences for a very large number of pathways, it is likely to find some as large ones as the ones reported in the PR. As a result, unless they control for this type of bias, the reported p-values are meaningless and may not be replicable in other samples.

The heatmap probably has no scientific value too and would not be surprised if for other "potential pathways," one observes larger differences for the placebo groups. Again, unless these pathways are pre-specified, there are no "super-responders" here.

As an ex-newbie in Biotech investing, an advice to past me would be to spend less time listening to CEO hopes and overoptimistic statements and more time understanding how FDA makes decisions.

Since when having a PhD/MBA makes you a saint?

After almost a year since the original PR, I am almost certain that they did not meet all the endpoints. At this point, we would have seen a clear statement instead of more confusing data. It seems that the market agrees with this too. The only hope now for bagholders is Rett in my opinion. Fingers crossed they are able to meet the endpoints and communicate that in a clear way and the price appreciation will follow.

"Our"? hahaha

Interested to hear by more experienced people here, if a confirmatory trial can be an extension of a previous trial. My maths say no, but I may be wrong.

Time to load on 2034 Feb'ish options

It is August, they are all on vacation and the EC was as "no news" as it could be. But yeah, the "we want to surprise the market" quote is ridiculous.

It is too early for him to say February, wait for the next EC.

Then AVXL shareholders are doomed. The good doctor could not see simple errors in basic stats, you have very high expectations of him.

I really hope he does get paid, given the amount of time he spends soft bashing a stock he likely does not own. It is the only rational explanation.

The last three letters are the most important in this post.

More accurately:

"We shall see what happens if and when an NDA is filed."

Every Anavex readout is a great opportunity for fantasising and daydreaming about what a holy grail 2-73 is as we have no meaningful data to make realistic and meaningful projections. Let's keep on dreaming.

Or it was intended to show statistical significance because RSBQ did not.

Lol, they went back to RSBQ for Excellence. So it is not a flawed measure after all and FDA has no issues with it.

How about this wording?

Missling (2023):

While 3 millenniums ago:

Unknown Author, Ecclesiastes 6:11 (~935 B.C.)

It is also important for biotechs to make things clear to investors. Many retail investors are exposed to complex scientific outcomes and it is the company's responsibility to present its science in a clear and transparent way for these investors. It is not surprising that there is plenty of evidence that complex language in press releases leads to lower stock prices.

It is certainly not the investor's fault to imply that "FDA suggested not to use the RSBQ measure and approved instead the change to RSBQ-AUC" based on the AVATAR CC. However, this is far from true.

Unfortunately, there is still lots of misinformation about AVATAR, and this is again the company's fault. I will try to clear it up a bit here.

By reading carefully the information sent out by the company and not falling for rumours spread without evidence here.

AVATAR update



So, as I said, FDA did not approve the change in the endpoints.



Nope, they never suggested that. This was Anavex's interpretation of a generic guidance from 2009. Not sure if many people here realise that, but RSBQ-AUC has never been used by any other company/researcher. RSBQ-AUC is Anavex's invention, and this makes it hard to claim a clear win for AVATAR.



FDA did not mention RSBQ in that guidance at all. On the contrary, in two months, they will probably approve Trofinetide based on the raw RSBQ change.

At the same time, Anavex likely failed to show significance with regard to the raw RSBQ change at 7 weeks which was the original endpoint and they will try to convince the agencies based on their own invented measure. Unless they come back with something new again with Excellence.

FDA definitely did not approve the change in the endpoints.

As long as they fix their errors, it is a good thing they removed it.

The difference is minimal and, as such, uncertain whether the slightly reduced rate is due to chance or not.

Yes, great news that there was no news!

Normality can also be tested using a Jarque-Bera test, which is more prevalent in my field, even though SW tends to be a bit more powerful in some cases. I would not be sure though they carried out any such test given that their statistical analysis has more major issues than a potential violation of the distributional assumption.

Not really.

Thank you, I will check it out and maybe post a comparison.

Well, the markets say otherwise.