OFP

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Posts	1,389
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Alias Born	12/13/2011

OFP

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OFP

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OFP

12/04/19 10:38 AM

Post #222089 on Anavex Life Sciences Corp (AVXL)

I actually believe the science applied for today’s PR is sound

I'm sorry but there is no possible way to say it is sound science to take the surviving subset of a small study, use a post hoc analysis criteria that pulls out the top performers (just a few patients), and then compare those patients to a general group only matched for demographics/genetics...the numbers of ways this is unsound are many and even if they compare top quartile to top quartile (a movement toward more sound) it would still be problematic.

OFP

12/04/19 9:35 AM

Post #222040 on Anavex Life Sciences Corp (AVXL)

Just to be clear, I’m supposed to believe that Dr Missling and our board of directors and our scientific advisory board and the FDA-collaborating data analysis firm Ariana are all collectively involved in presenting a “bogus” comparison at CTAD in a late-breaking oral presentation? Makes total sense, thanks

After years of selectively revealed data, questionable statistics, and misleading formulation of data IMO, THAT IS EXACTLY WHAT YOU SHOULD BELIEVE. They are in the business of pumping up the pps so they can sell more shares to finance their jobs almost regardless of prospects.

It is a demonstrably problematic comparison...is that not apparent???????????????????????????????????????????????

OFP

12/04/19 8:55 AM

Post #222016 on Anavex Life Sciences Corp (AVXL)

This may be the key sentence in the PR:

IMO...the following is the key sentence:

Change in MMSE score from baseline at week 104 of matched cohorts was assessed. It showed that ANAVEX®2-73 (blarcamesine) high dose cohort had a significantly lower MMSE decline (-1.1) compared to the ADNI control cohort (-4.4) at week 104 (p < 0.01).

So basically they took their gerrymandered top quartile and compared it to an unselected group (other than demographic/genetic matching as described). It's a bogus comparison.

OFP

12/03/19 2:42 PM

Post #221915 on Anavex Life Sciences Corp (AVXL)

AVXL is not different. Same rules apply to all.

That is preposterous what other company uses AI, precision medicine, microbiome inquiries, and has the TGA in it's pocket?

They are so special I don't even recall what compound they are testing or if it even matters.

OFP

12/03/19 2:39 PM

Post #221913 on Anavex Life Sciences Corp (AVXL)

Were they doing precision medicine trials and research in Australia?

This is a critical deficiency

Not a whisper of lip service to precision medicine.

OFP

12/03/19 11:31 AM

Post #221860 on Anavex Life Sciences Corp (AVXL)

This manipulation was predicted before news...

Heck yeah...can't wait for the microbiome news...it's going to start a massive movement. Buying opportunity NOW!!....almost as good as the next one.

OFP

12/02/19 3:22 PM

Post #221735 on Anavex Life Sciences Corp (AVXL)

Yeah brain bleed vs dizzy.

Both real, but really????

I'll chose dizzy.

I'll choose a risk-benefit analysis

OFP

12/02/19 3:21 PM

Post #221734 on Anavex Life Sciences Corp (AVXL)

I predict that passionate opposition devoid of reasoned thought will continue until provisional approval by the TGA is fait accomplis (done) .

This infinite timeline neglects a point at which there is no longer anything to oppose.

OFP

12/02/19 3:16 PM

Post #221731 on Anavex Life Sciences Corp (AVXL)

Everybody who is hoping Biogen falls flat on its face should stop and consider the damage every failure does to the entire Alzheimer's sector.

I don't like this line of thought...what about the damage if there's no true improvement?...a very real possibility for aducanumab and almost a certainty for 2-73.
1. Huge expense...health care dollars diverted from where they might actually do good
2. Impairment of getting something truly effective to market due to both bogus competition and people being less likely to enroll in or being excluded from trials
3. Very real adverse effects for both aducanumab and 2-73

Maybe it's good for investment but not good for our society.

OFP

12/02/19 2:49 PM

Post #221724 on Anavex Life Sciences Corp (AVXL)

I predict a strong rebuttal to your post.

Strong in terms of passion, not so much in terms of reasoned thought.

The dismay that there is no provisional approval is just one of many disappointments on the road to the final dagger.

OFP

11/27/19 2:10 PM

Post #221188 on Anavex Life Sciences Corp (AVXL)

Sleep quality is a given in CNS therapy.

Improved cognition is a given in real dementia therapy.

I'd be a bit concerned that so much hope seems to lie in a few survey questions from 7 or 8 patients regarding a tenuously related issue.

OFP

11/27/19 1:02 PM

Post #221181 on Anavex Life Sciences Corp (AVXL)

No need to prove a damn thing!

I do believe that is Missling's battle cry.

Mission accomplished!

OFP

11/27/19 12:21 PM

Post #221170 on Anavex Life Sciences Corp (AVXL)

Where does it say can't stand up?

I believe you just moved from an "any factual data" request to a specific factual data request. Progress!

Recall this? "The
most
common
AE
was
dizziness"

OFP

11/27/19 12:16 PM

Post #221168 on Anavex Life Sciences Corp (AVXL)

Perhaps that you have forgotten that controlled data may not be required.

"The magical AVXL is different than every other company because we want it to be" hope

OFP

11/27/19 12:14 PM

Post #221165 on Anavex Life Sciences Corp (AVXL)

You can not support this with any factual content.

5 weeks in and 75% had to drop their dose. 5 weeks!

OFP

11/27/19 12:10 PM

Post #221163 on Anavex Life Sciences Corp (AVXL)

Perhaps you don't realize that sleep is a key biomarker for CNS health. It has occurred in all of the 2-73 indications.

Perhaps you don't realize they do not have any controlled data for that. Perhaps you don't realize that sedation is not automatically a good thing and may play a role in the observed toxicity.

OFP

11/27/19 12:07 PM

Post #221162 on Anavex Life Sciences Corp (AVXL)

"The Australian hope"...

1. Participate in Australia's initiative to attract biotech research
2. Call the tax credits a grant
3. People see "grant" and think Australia is supporting AVXL research
4. Let those thought marinate in the message boards enough to the point they think Australia has shown interest in AVXL (they haven't)
5. Take many further leaps to get to "provisional approval"

OFP

11/27/19 12:04 PM

Post #221160 on Anavex Life Sciences Corp (AVXL)

"The sleep hope" - 75% of patients on the top dose can barely stand up. It's not surprising they are sedated as well. How about the unintended hypotension? AVXL once again spinning side effects as a positive.

OFP

11/27/19 11:56 AM

Post #221156 on Anavex Life Sciences Corp (AVXL)

Conclusions are absurd for a drug with proven capability in several trials to provide healing sleep for CNS sufferers.

There are no proven capabilities. In fact, all AD indications are the opposite despite the predominate themes of this forum. Do you realize the sleep "hope" (not proof) is based on small sample of a subset of questions on a depression scale SURVEY in patients that were screened to not be depressed?

Furthermore, this sleep "hope" is NOT WHAT IS BEING TESTED. If there is no cognitive/ADL benefit it fails.

OFP

11/27/19 11:35 AM

Post #221152 on Anavex Life Sciences Corp (AVXL)

Quote:Heard this story about perfect storm coming for last 3 years - now everything moved to 2020.

The longer it takes to get RCT results, the longer before he has to reboot the company and start talking about how 3-71 is so promising during the reverse split and toxic financing.

All the hopeful talk about an essentially impossible "provisional approval" while the above scenario is the 99% probability.

Wouldn't want this to drop off the 1st page. Most important take of the day.

OFP

11/27/19 6:10 AM

Post #221088 on Anavex Life Sciences Corp (AVXL)

Heard this story about perfect storm coming for last 3 years - now everything moved to 2020.

The longer it takes to get RCT results, the longer before he has to reboot the company and start talking about how 3-71 is so promising during the reverse split and toxic financing.

All the hopeful talk about an essentially impossible "provisional approval" while the above scenario is the 99% probability.

OFP

11/21/19 4:19 PM

Post #220359 on Anavex Life Sciences Corp (AVXL)

Predictions (from late 2017) of when the blinded Rett study would read out top line data:
5/20/2019
4/1/2018
12/31/2017
5/29/2018
6/1/2018
7/1/2018
6/30/2018
2/14/2018
6/1/2018

One of those guesses was mine so I'm guilty of over-"optimism" as well. But a good reminder of how easy it is to be off the mark when rooting for results.

OFP

11/15/19 5:08 PM

Post #219297 on Anavex Life Sciences Corp (AVXL)

What AVXL trial has juvenile participants?

The defendant in Missling v. Shareholders

(cheap shot, couldn't resist)

OFP

11/14/19 3:13 PM

Post #219143 on Anavex Life Sciences Corp (AVXL)

They can’t sell the voucher today because that haven’t got it yet.

Does this imply that at some point they might be able to sell it?...would not make sense

OFP

11/14/19 3:10 PM

Post #219141 on Anavex Life Sciences Corp (AVXL)

A cabal conspiracy theory does not apply.

Yeah, totally irrelevant. Nothing to see here. Move along.

"The greatest trick the devil ever pulled was convincing the world he didn't exist."
-Roger "Verbal" Kint (aka Keyser Söze)

OFP

11/13/19 9:44 AM

Post #218840 on Anavex Life Sciences Corp (AVXL)

Can’t open your link

If this doesn't work:

then it's p8 of the Oct presentation

Don’t forget that objective biomarkers were also correlated

As I said, they had some data that were encouraging. Instead they showed just showed 2 worthless correlations and, if my quick scan of that presentation is correct, didn't really go back over the findings summary.

Correlation COULD also be causation

...when variables are possibly independent this is nontrivial. When variables are constructed to be dependent then a correlation is trivial.

OFP

11/13/19 8:21 AM

Post #218820 on Anavex Life Sciences Corp (AVXL)

AVXL loves correlations

You can’t have causation without correlation, also worth remembering.

AVXL gives a lovely example of their love of correlations with their PK Rett results graphs. They had some encouraging findings for this PK portion but do they highlight them?...NO!...they give a graph of the correlation of CGI (global impression) and RSBQ (behavior questionnaire). The graph shows a very strong correlation and a nice upward trajectory...boy that sure supports the investment thesis, right?

What does it mean that global impression and behavior are correlated?...if their behavior is better then the impression of how they are doing is improved. Wow, what a shocking revelation. Not that it would have really improved this mockery of intellect but they don't even show more than one time point to assess if there was a change in this trivial correlation.

Another example of AVXL using selected data to sway the unwary rather than focus on the messier, more difficult to understand, but actually relevant, data.

OFP

11/12/19 6:59 PM

Post #218772 on Anavex Life Sciences Corp (AVXL)

Yep... news is just around the corner!
Holding and accumulating what manipulation gives us. Thanks!

Let me guess, a golden buying opportunity here?...just like every other point in time for the past 5 years?

OFP

11/12/19 6:51 PM

Post #218766 on Anavex Life Sciences Corp (AVXL)

Try not to confuse correlation with causation. It will usually lead to wrong hypotheses.

Have you mentioned this to Missling?

OFP

09/17/19 11:07 AM

Post #210228 on Anavex Life Sciences Corp (AVXL)

The thing, though, that encouraged me the most was the correlation between the GABA/glutamate (objective)

Yes, I'd probably be largely discounting this all if it weren't for that...though I still need to get a better feel for the implications of those markers. Obviously, it's not an automatic to say..."Glu is elevated in Rett, our drug is associated with reduced Glu, THEREFORE our drug treats Rett".

...nor is it fair to say that is all they are claiming. Just making the point I need to catch up on the implications.

OFP

09/17/19 10:09 AM

Post #210205 on Anavex Life Sciences Corp (AVXL)

There was no placebo group in the initial PK study reported from with 6 patients. Confirmation comes from the now ongoing placebo controlled study in the US n=15 and the AVATAR study n=30 in AU.

Ah, ok...so I'll be waiting a lot longer to get a clearer picture.

OFP

09/17/19 10:07 AM

Post #210202 on Anavex Life Sciences Corp (AVXL)

your concern about the N small number I understand but the placebo group here is useless. The p statistic is comparison of improvement of those girls before and after taking AZ2-73 and this is very important IMO.

Well I disagree...you have a caregiver administered test with a very hopeful group of parents...it's a set up for "improvement". Need the placebo control to really know.

OFP

09/17/19 10:05 AM

Post #210197 on Anavex Life Sciences Corp (AVXL)

The 6 patients being open label with parents 100% sure their child received drug could affect the subjective scales

I thought this was placebo controlled as per this protocol:
https://clinicaltrials.gov/ct2/show/NCT03758924?term=Anavex&rank=4

Did I get that wrong? Was wondering why they unblinded an early group but maybe it was never blinded?

OFP

09/17/19 10:01 AM

Post #210192 on Anavex Life Sciences Corp (AVXL)

What is your overall view on those initial Rett results?

Well I'm sure no one will be shocked if I say I'm not drinking the Kool Aid yet. That being said the degree of RSBQ change, the glutamate/GABA changes, and the Kaufmann statement are all positive.

What gives me pause is the low N and comparisons to baseline rather than to placebo. They finally get a placebo control group and choose not to use it?...makes no sense. Clearly they are once again cherry-picking data but there's still enough to be intrigued by...I'm waiting to see the end of month detailed data to hopefully see the reality of it before coming down strongly on one side or the other.

OFP

09/17/19 9:27 AM

Post #210170 on Anavex Life Sciences Corp (AVXL)

Wouldn't mean all the girls started at 50?

No...it's a group average. Lower scores are better so the average moving from 50 to 34 is improvement.

OFP

09/12/19 3:18 PM

Post #209407 on Anavex Life Sciences Corp (AVXL)

Actually, sigma 1 receptor is a pluripotent modulator of cell survival that interacts with many structurally diverse proteins and Anavex 2-73 is very effective agonist of the sigma 1 receptor. The sigma 1 receptor is a endoplasmic reticumum chaperone that assists in the proper folding on proteins.

You don't say???

So it's the receptor that is a pluripotent modulator and not 2-73? I'm sure AVXL didn't mean to mislead on that.

OFP

09/12/19 2:57 PM

Post #209404 on Anavex Life Sciences Corp (AVXL)

ANAVEX 2-73 Sigma-1 Receptor Agonist "Pluripotent Modulator"

The above words appear in the graphic bubble that takes center stage in the slide shown.

Isn't it great that 2-73 is a pluripotent modulator? And the proof is right there bottom left with the paper by Su et al with title highlighting the pluripotent modulator aspect.

OFP

09/11/19 5:49 PM

Post #209314 on Anavex Life Sciences Corp (AVXL)

If his Janney presentation was anything like his quarterly calls or previous conference presentations, it was off the cuff. "Polished" is not an adjective I would apply to his presentations.

Personally I thought he was less comfortable and more stumbling than usual. I don't really attach any weight to these "tone" assessments and I attributed the drop off to the fact that it was longer than his usual presentations so he had more material to cover with less polish.

As for content...usual AVXL themes. Lots of generic S1R effects supposed to somehow work better with 2-73. Autophagy was one of these but of course neglected to mention PRE084 did the same thing. Quite a bit of time on Rett and associated trials. PDD top line is "coming up". AD is "enrolling nicely" and has a "standard design"

Highlighted AD extension still going after 3 years but neglected any mention of number of pts still enrolled or their status = worthless

Mentioned licensing...personally, I view this as entertainment value only.

OFP

09/11/19 3:20 PM

Post #209295 on Anavex Life Sciences Corp (AVXL)

So your saying Cocaine, which actives the S1R, has the same effect on the body the same a dextromethorphan (Robitussin DM), which is another S1R drug? Ridiculous. You dont need to be a bio-chemist to know this is completely false and very,very misleading.

-Fireman

Well, you might need to be a bit closer to a biochemist to realize that pure S1R agonists are not clinically available and that cocaine mediates the effects you are thinking of through the monoamine system and DM likely exerts most of it's effects as an NMDA antagonist in addition to S1R and SERT effects.

Thanks for caring so much.

Hopefully you understand a bit better.

OFP

09/09/19 11:55 AM

Post #208940 on Anavex Life Sciences Corp (AVXL)

A cursory glance makes it look worthy of further investigation

Interesting...it's the former PTIE so a bad taste in many mouths with the company. That being said, an entirely different avenue for them, they are trading close to cash, cash burn is low given NIH is paying for their trials.

Down 10% on "positive" biomarker results shows just how much the market likes biomarkers without demonstrated cognitive benefit (either that or it's the cabal).

Phase 2b trial is already started/recruiting, is a RCT, will end in the spring, and includes (simple) cognitive measures as secondary endpoints. May be tough to show cognitive effects in only 28 days. Have to say it's on my radar...may take a shot on that long shot.

CC today at 4:15PM
An older article on PTI-125: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6621293/ (a 2017 update from same author is available)
2b trial

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