Anavex Life Sciences Corp (AVXL)

[georgejjl]

No it is NOT a failure. p<=0.05 is an arbitrary cutoff chosen a century ago by R A Fisher FRS. Other factors like effect size and safety, etc. need to be used to determine failure. Any intelligent statistician would agree.

Blarcamesine's Phase 2b/3 for treating early stage Alzheimer's disease is a success. THAT IS A FACT!!!

GOD bless,

[BarrellofHay]

Well, if I was an FDA decision maker and saw that 10-15% of the population improved -4 from baseline after 48 weeks when most patients deteriorate +4, I would be inclined to approve just based on this and the safety profile even if the 85-90% "other" patients did not show much of a mean difference, as long as they were not getting worse than placebo, which I am sure they are not. This is life changing for 600,000 to 1 million Americans. Now if you can find a biomarker for this population, then the FDA would have to approve, there would be zero reason not too. With 10-15% super responders and a biomarker = 100% approval chance as long as safety is good. 10-15% super responder without a biomarker, I give 80% chance on this alone.

[gbrown6332]

Anyone have a sense for how well the Anavex poison pill is setup. Starting to wonder if the relentless engineered drop is more than just shorts and hedge funds playing reindeer games.

[kund]

Problem is running tiny phase2a and basing everything on it for all other trial design. If Misleading had ran proper phase2 with 100+ patient and placebo control instead of that tiny OLE OLE, this situation of dizziness would have been avoided.

[pcguy]

Anavex had to collect the raw data for an odds ratio analysis. The problem is that Anavex may not be able to prove statistical significance using a traditional analysis. There is an argument by the company that titration complicated the analysis, but that is because of the trial criteria only. An analysis could be performed on the end dosage, however that would not align with the trial design for inclusion in each group. It is a paper vs reality thing. There is no way to separate the groups into maximum tolerated dosage with a placebo arm. Undoubtedly, a negative spic could be used on any further analysis, but it is all BS.

Since the trial was blinded a post-hoc analysis should be able to be performed with maximum tolerated dosage, pooled, to show benefit. The problem will be, if the 30mg group does not show statistical significance and the 50mg group does. Again, it would be BS, but you could not pre-specify who could tolerate the drug prior to dosing unless additional biomarkers are identified. This is BS, because the drug has shown to be safe and tolerable, regardless of the dosage. Take your chances and find out... the 'take at bedtime' caveat will probably also have naysayers because there is no evidence to support this case.

A real doctor would be able to understand a post-hoc analysis and not throw thier arms up on semantics.

If the trash was taken out at 6:05, and they said they would do it at 6:00, and the trash truck runs at 7:00, the result will be the same if you're only worried about getting rid of the trash.

[XenaLives]

Blocks >=1K this AM...

 
 12/09/22	11:32:46	7.73	7.70	7.73	1,000 
 12/09/22	11:32:15	7.73	7.70	7.73	1,200 
 12/09/22	11:31:25	7.70	7.68	7.70	1,000 
 12/09/22	11:30:15	7.70	7.70	7.71	1,000 
 12/09/22	11:29:18	7.70	7.67	7.68	1,000 
 12/09/22	11:28:34	7.6801	7.68	7.69	4,700 
 12/09/22	11:28:30	7.6806	7.68	7.69	2,000 
 12/09/22	11:26:51	7.68	7.68	7.70	1,100 
 12/09/22	11:25:18	7.6777	7.66	7.68	1,000 
 12/09/22	11:24:51	7.68	7.68	7.69	3,200 
 12/09/22	11:24:35	7.6815	7.68	7.69	6,000 
 12/09/22	11:24:35	7.6899	7.68	7.69	1,100 
 12/09/22	11:24:14	7.6907	7.69	7.70	4,000 
 12/09/22	11:23:38	7.6901	7.69	7.70	1,900 
 12/09/22	11:23:06	7.7001	7.70	7.71	5,400 
 12/09/22	11:23:01	7.7037	7.70	7.71	1,500 
 12/09/22	11:22:51	7.70	7.71	7.72	1,000 
 12/09/22	11:22:51	7.71	7.71	7.72	1,100 
 12/09/22	11:22:51	7.71	7.71	7.72	2,100 
 12/09/22	11:21:59	7.7111	7.71	7.72	1,400 
 12/09/22	11:18:59	7.74	7.73	7.74	1,000 
 12/09/22	11:18:53	7.74	7.74	7.75	3,300 
 12/09/22	11:18:05	7.77	7.77	7.78	1,000 
 12/09/22	11:14:51	7.76	7.75	7.77	1,000 
 12/09/22	11:14:35	7.77	7.77	7.78	3,200 
 12/09/22	11:11:56	7.79	7.78	7.79	2,000 
 12/09/22	11:10:06	7.78	7.78	7.80	1,288 
 12/09/22	11:03:11	7.84	7.83	7.85	1,435 
 12/09/22	11:03:11	7.83	7.84	7.86	6,900 
 12/09/22	11:02:33	7.8293	7.82	7.83	1,000 
 12/09/22	11:02:09	7.83	7.82	7.84	1,000 
 12/09/22	11:01:05	7.81	7.85	7.87	10,800 
 12/09/22	11:01:05	7.81	7.85	7.87	1,200 
 12/09/22	10:58:42	7.8277	7.81	7.83	1,000 
 12/09/22	10:58:23	7.8201	7.80	7.82	1,400 
 12/09/22	10:55:28	7.8399	7.82	7.84	1,000 
 12/09/22	10:54:30	7.85	7.83	7.85	1,700 
 12/09/22	10:53:58	7.83	7.81	7.82	5,900 
 12/09/22	10:53:58	7.83	7.81	7.82	16,600 
 12/09/22	10:53:26	7.82	7.81	7.82	1,100 
 12/09/22	10:52:24	7.82	7.80	7.81	3,000 
 12/09/22	10:49:25	7.81	7.80	7.82	2,356 
 12/09/22	10:49:25	7.80	7.81	7.82	3,400 
 12/09/22	10:49:25	7.80	7.81	7.82	1,000 
 12/09/22	10:49:25	7.80	7.81	7.82	1,000 
 12/09/22	10:49:25	7.80	7.81	7.82	1,200 
 12/09/22	10:49:16	7.82	7.82	7.83	1,900 
 12/09/22	10:45:54	7.86	7.85	7.87	1,000 
 12/09/22	10:39:27	7.9199	7.90	7.92	1,400 
 12/09/22	10:37:39	7.9201	7.92	7.93	2,000 
 12/09/22	10:35:26	7.83	7.82	7.84	2,500 
 12/09/22	10:33:02	7.85	7.85	7.86	1,000 
 12/09/22	10:33:02	7.85	7.85	7.86	1,100 
 12/09/22	10:31:22	7.86	7.86	7.87	2,500 
 12/09/22	10:31:14	7.8656	7.86	7.87	1,500 
 12/09/22	10:31:14	7.86	7.86	7.87	1,500 
 12/09/22	10:30:11	7.84	7.82	7.84	2,400 
 12/09/22	10:26:19	7.83	7.86	7.87	4,500 
 12/09/22	10:26:19	7.841	7.86	7.87	1,800 
 12/09/22	10:22:48	7.9299	7.92	7.93	1,500 
 12/09/22	10:22:44	7.92	7.91	7.93	1,000 
 12/09/22	10:22:03	7.92	7.91	7.92	1,100 
 12/09/22	10:21:47	7.8873	7.88	7.91	3,000 
 12/09/22	10:21:39	7.90	7.86	7.89	2,700 
 12/09/22	10:21:38	7.89	7.86	7.89	1,000 
 12/09/22	10:20:07	7.853	7.85	7.86	2,000 
 12/09/22	10:19:41	7.8403	7.84	7.86	1,000 
 12/09/22	10:18:29	7.8301	7.83	7.85	5,000 
 12/09/22	10:18:28	7.8494	7.83	7.85	1,000 
 12/09/22	10:17:58	7.8301	7.83	7.85	5,000 
 12/09/22	10:16:21	7.816	7.81	7.84	3,000 
 12/09/22	10:16:07	7.83	7.83	7.85	2,700 
 12/09/22	10:15:50	7.85	7.85	7.86	1,800 
 12/09/22	10:13:45	7.84	7.84	7.85	2,000 
 12/09/22	10:13:39	7.8499	7.84	7.85	1,300 
 12/09/22	10:12:53	7.85	7.83	7.85	1,400 
 12/09/22	10:12:36	7.8317	7.83	7.85	3,000 
 12/09/22	10:12:32	7.83	7.83	7.86	1,300 
 12/09/22	10:11:49	7.83	7.83	7.85	4,200 
 12/09/22	10:11:49	7.83	7.83	7.85	1,000 
 12/09/22	10:11:49	7.83	7.83	7.85	2,800 
 12/09/22	10:11:49	7.83	7.83	7.85	1,100 
 12/09/22	10:11:47	7.84	7.86	7.88	4,400 
 12/09/22	10:11:47	7.84	7.86	7.88	1,100 
 12/09/22	10:11:47	7.85	7.86	7.88	5,000 
 12/09/22	10:11:47	7.86	7.86	7.88	3,400 
 12/09/22	10:11:22	7.89	7.89	7.91	2,000 
 12/09/22	10:11:22	7.89	7.89	7.91	3,000 
 12/09/22	10:11:16	7.89	7.90	7.92	1,100 
 12/09/22	10:11:16	7.90	7.90	7.92	1,000 
 12/09/22	10:09:46	7.9227	7.91	7.94	2,800 
 12/09/22	10:09:30	7.9251	7.92	7.94	1,000 
 12/09/22	10:06:59	7.90	7.91	7.94	1,296 
 12/09/22	10:06:58	7.90	7.94	7.96	1,000 
 12/09/22	10:06:58	7.90	7.94	7.96	11,200 
 12/09/22	10:06:58	7.91	7.94	7.96	1,700 
 12/09/22	10:06:58	7.92	7.94	7.96	3,400 
 12/09/22	10:03:51	7.98	7.97	7.99	1,500 
 12/09/22	10:01:16	8.03	8.01	8.03	3,000 
 12/09/22	10:01:08	8.00	7.98	8.00	1,300 
 12/09/22	10:00:01	7.9991	7.98	8.01	3,000 
 12/09/22	10:00:00	8.00	7.98	8.01	1,000 
 12/09/22	10:00:00	7.99	7.98	8.01	2,555 
 12/09/22	09:59:43	7.97	7.97	7.99	2,400 
 12/09/22	09:58:29	7.95	7.96	7.98	3,300 
 12/09/22	09:57:32	7.9795	7.97	7.99	1,100 
 12/09/22	09:52:05	8.0155	8.01	8.02	1,500 
 12/09/22	09:50:39	7.97	7.97	7.99	1,000 
 12/09/22	09:50:30	7.98	7.97	7.99	1,200 
 12/09/22	09:49:57	7.98	7.97	7.99	2,200 
 12/09/22	09:49:12	7.9696	7.94	7.99	1,800 
 12/09/22	09:45:45	8.00	7.99	8.02	1,011 
 12/09/22	09:45:45	8.00	7.97	8.00	1,800 
 12/09/22	09:45:45	8.00	7.97	8.00	1,100 
 12/09/22	09:45:31	7.985	7.97	8.00	1,300 
 12/09/22	09:45:16	7.96	7.94	7.98	2,000 
 12/09/22	09:43:49	7.9201	7.92	7.94	3,000 
 12/09/22	09:42:39	7.9499	7.92	7.95	5,000 
 12/09/22	09:42:23	7.9453	7.92	7.97	1,500 
 12/09/22	09:41:13	7.9204	7.90	7.93	3,000 
 12/09/22	09:40:58	7.9201	7.92	7.94	2,000 
 12/09/22	09:40:42	7.94	7.95	7.99	2,000 
 12/09/22	09:38:07	7.9675	7.94	7.99	1,000 
 12/09/22	09:36:43	7.9309	7.92	7.97	2,700 
 12/09/22	09:35:54	7.9201	7.92	7.98	1,000 
 12/09/22	09:34:17	7.95	7.98	8.04	2,600 
 12/09/22	09:32:26	7.90	7.90	7.94	1,000 
 12/09/22	09:31:20	8.0148	7.98	8.07	1,900 
 12/09/22	09:31:19	8.0452	7.98	8.07	1,000 
 12/09/22	09:30:00	7.99	7.97	8.18	27,100 
 12/09/22	08:56:51	8.00	8.00	8.08	1,000 
 12/09/22	08:29:33	8.11	8.08	8.12	1,000 
 12/09/22	08:22:08	8.10	8.08	8.10	5,000 
 12/09/22	08:00:03	8.01	8.06	8.18	3,300 
 12/08/22	19:18:56	8.08	8.05	8.08	1,200 
 12/08/22	18:33:44	8.00	8.00	8.07	1,500 
 12/08/22	18:17:40	8.05	8.00	8.08	1,200 
 12/08/22	17:28:42	8.1094	8.03	8.11	1,000 
 12/08/22	17:26:08	8.1092	8.03	8.11	2,000 
 12/08/22	16:49:45	8.08	8.03	8.07	16,700 
 12/08/22	16:12:31	8.08	8.04	8.11	2,000 
 12/08/22	16:01:08	8.08	8.03	8.15	1,200 
 12/08/22	16:00:05	8.08	8.04	8.18	2,000 
 12/08/22	16:00:01	8.08	8.04	8.18	1,400 
 12/08/22	16:00:01	8.08	8.04	8.18	2,500 
 12/08/22	16:00:01	8.08	8.04	8.18	99,200 
 12/08/22	16:00:01	8.07	8.04	8.18	90,628 
 12/08/22	15:59:59	8.07	8.06	8.08	3,300 
 12/08/22	15:59:59	8.07	8.06	8.08	2,000 
 12/08/22	15:59:58	8.08	8.06	8.08	8,188 
 12/08/22	15:59:35	8.08	8.07	8.08	1,700 
 12/08/22	15:59:29	8.08	8.07	8.08	1,600 
  
 

[jav0033]

Losing 5% per day.

Can we halt this until they finish crunching the numbers??

Asking for some friends bleeding money every day.

[JWC3]

ANAVEX has been extremely truthful in its revelations of trial results. They have been successful MEETING all endpoints of all the trials:
P2a AD
P2a/3 AD
PDD
RTT
AVATAR.

Expect same success from:
EXCELLENCE
FRAGILEX.

Extremely efficacious and very
safe drug in A 2-73

[end2war]

My thoughts:
1. Missling claimed in the CTAD PR and in the Monday after reiteration that the trial met its endpoints, but so far has not offered traditional proof because it probably does not exist in the traditional form of compared placebo mean values vs drugged mean values at each dose for the full ITT population.
2. There is no question that the data presented leaves a lot of valid questions unanswered. Misslings selective presentation suggests he is intentionally withholding some negative data he presently has, because he wants to present it in a broader context, hoping to explain the problems that occured during the trial.. Essentially, it looks like Missling is putting together an argument from the data that supports his premise that the endpoints have been met; and the market is very skeptical that this is possible. So, at best the market thinks another PH 3 trial is required, and at worst, that the present trial is a complete failure.
3. Clearly, Missling wants to use odds ratios, claiming they were preapproved by the regulatory agencies, but he has not shown an SPA or other indication of how these odds ratios have been preapproved. So, the market is not satisfied that odds ratios are, in fact, preapproved endpoints, despite what he has claimed. Furthermore, even if they were preapproved, they cannot suffice in the form presented in the CTAD report without more specific data than has been provided so far, and an FDA that is willing to consider the arguments Missling will make.
4. Using information presented, the mathamatically inclined posters have developed a lot of theories about what the data must show. Much of these argments boils down to the theory that the full data seems to indicate subgroup analysis is necessary to support any showing of clinical benefits. This is okay if it can show how to handle the 30 and 50 mg groups, since they were prespecified. But, the data set seems to be flawed by problems that developed during the trials that have only been partly disclosed so far. Subgroup analysis alone is not usually sufficient if it was not prespecified, and the data is flawed in ways that the subgroup analysis is likely to be problematic, or at least, may be problematic. We don't know the extent of problems at this point.
5. Probably everyone that started the trails has a baseline value; but, even that has not been clearly stated so far. The data presented so far is quite confusing as to the numbers of participants used in calculations. For example, a significant number of placebos and drugged patients did not finish the trials, which creates complications for evaluating the results. These numbers are hinted at but not clearly revealed, so far.
6. Also, an unstated number of the 30 MG and some of the 50 MG groups apparently got reduced doses.Many participants became dizzy when receiving drugs and the dosing was changed to night time. It is not presently clear how much, but these dose changes may have messed up the original trial design of one group getting 30 mg while the other group got 50 mg, leaving problems in how to evaluate the results in these two groups.(The trial did allow for titration differences, but it now appears this could be a problem.) Some are suggesting that only a pooled evaluation is possible; while others are saying that Missling will try to develop a potentially complex and confusing separation of the 30 and 50 Mg groups.
7. Despite the data problems, the calculations made by the CRO seem to say that A-273 is an active drug for some super responders who improved and recovered cognition and ADL, but we can only guess at how many their are in this group. It seems like something on the order of 10 to 60 possibly got some outstandingly clear improvement at 48 weeks. This kind of result, if correct, could put A-273 into position for regulatory approvals, but it is going to depend on how many super responders there are and whether the P numbers show clear statistical significance that the drug is causing these results. This seems to be likely at this point, IMO.
8. There also seems to be a relatively large group of drugged patients, that although they are not super responders, are good responders with clinically significant slowed rates of decline after 48 weeks, that can be shown to have resulted from the drug, with statistical significance.
9. The odds ratio information, while standing alone, probably is not enough, but when combined with the responders that obtained statistically signficant improvements and slowing of decline, if those results can be statistically shown with proper P values, may be enough, considering the demonstrated safety of A-273 and the large unmet needs.
10. Missling has produced what seems to me to be a strong argument that the Anavex trial data is better than BIIB's data for Aduhelm (an approved drug) and probably beats BIIB's new drug too with a clear margin. BUT THIS IS NOT YET CLEAR FROM THE DATA PRESENTED AND ONLY IMPLIED FROM THE TOP LINE REPORT CLAIMS.

Conclusion. AVXL's A-273 is an active drug that impacts AD patients and its other drug that activates SR1 needs investigation. Big Pharma will buy Anavex and the present PPS is undervalued, unless Missling is committing fraud (unlikely, but possible) in the statements presented in the top line results.Otherwise, another trial is likely needed for AD; but it is likely the Rett's trial coming may have the evidence needed for approval of the Retts indication.

[longtermbeliever]

did you see it??.JUST HOLD ON TIGHT LOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOONGS

[boi568]

Your educated guess of 10 to 15 percent super responders matches the observation MacFarlane gave to Mayomobile in San Francisco.

[longtermbeliever]

watch i put 15k block at $7.70 right now test then i will cancel.JUST HOLD ON TIGHT LOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOONGS

[Investor2014]

Of course it is and in fact all patients must and will experience the same treatment regimen in a blinded randomised trial as no one knows which arm they are in.

The pills whether fake or dose are labelled with a patient ID by the computer and someone just brings the right pills to the right patient.

It gets a little more complicated with a titration scheme, but completely doable.

[longtermbeliever]

if i put my order in MM will not run it down trust me i done it many timei if it get this low buying market price is the best way to do it 5k,10k block is the best way to do it.JUST HOLD ON TIGHT LOOOOOOOOOOOOOOOOOOOOOOOONGS

[gbrown6332]

The howlers are demanding we blindly accept one of the following...

First - Scores of professional medical trial researchers across multiple disparate geographic locations somehow all colluded and sent falsified happy data to the independent third party CRO. That's not logistically possible and chances are ZERO.

Second, the reputation dependent CRO, who provides analytical services to multiple large BP's, allowed a gnat sized biopharma to browbeat them into falsifying their analysis. Ludicrous, absurd and the chances are ZERO.

Lastly, Anavex leadership who had a sliver of time to unwrap the dataset from the CRO before CTAD still had time to torture the numbers to fit their "met primary and secondary end points" narrative risking unimaginable consequences if that were false. Less than ZERO chance.

The field researchers, the CRO and Anavex leadership are all being unfairly discredited, should rightly have a major case of red A$$ and fight the lying SOB's supporting the AD status quo or newly rendered sub optimal BP solutions.

[LBSR TO DA MOON]

Short-term pain will result in long-term gain? Sure hope so. As always, time will tell...

[Investor2014]

The placebo effect is always at work to a lesser or greater effect in both the placebo and dose arms.

The study is blinded and randomised so no one will know which arm they are in.

Even the placebo arm is titrated by the identically looking but false A2-73 pills.

As MacFarlane has previously said, from who gets dizziness one might infer they are more likely to be in a dose arm.

[LBSR TO DA MOON]

C'mon LongTermBeliever! Go ahead and create that backstop at $7.50. Put your order in so we can see it. Prove once and for all to any "non-believers" out there that you are the real deal!

come on $7.5 so i can add 100k shares more.

[FooBarAndGrill]

Yes, I do see the column headed "Placebo (n=170)". I also see that 88% of the placebo arm was up-titrated. Is that still a valid placebo arm?

[bas2020]

Curious isn't it? Biogen and Lilly know what's at risk with Blarcamesine and are trying to pull their financial weight at FDA to "cut in line" with their crappy MABs.

[boi568]

Let's assume that the combined arms showed a near-miss for ADCS-ADL on the usual criterion but, as we see, a passing outcome on the odds ratio. Let's further assume that Missling has preliminary data showing this endpoint is hit -- no issues -- on the 50mg arm. That's where you and I are on this.

What does he do for CTAD? Because of the CRO screwup, he is left with a series of problematic choices:

1. He can withdraw from the presentation, explaining the need for further data analysis. While this, as we lawyers like to say, has the added benefit of being true, it will look terrible. It will be misread as a trial failure now being cherry picked.

2. He can say we missed the ADL endpoint on existing data analysis, which will be taken badly, of course, and is in fact inaccurate -- he has not-ready-for-prime-time reliable information that this endpoint is met in the 50mg arm. But where would he he go from there? The implication then would be the 50mg result cannot be enough for an NDA, and that's not accurate, either.

3. Missling could release the 50mg ADL outcome, pending the rest of it later. However, that is classic cherry picking, and even then the 50mg result might be subject to some later minor adjustment (not affecting the basic result).

4. So he instead, knowing what will come in the 50mg results, announced the endpoint as met and used the odds ratio test as a temporary patch. This isn't working out great at the moment, either, but a month from now it will look the best of a bad set of options.

[BarrellofHay]

Well, a placebo titration shouldn’t effect any placebo outcomes right. So calculations there stay constant I would imagine

[longtermbeliever]

come on $7.5 so i can add 100k shares more.JUST HOLD ON TIGHT LOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOONGS

[sab63090]

Yes, I believe that is exactly what is now happening....notice the large open interest in the Jan 20, 2023 puts vs the way smaller call open int...I realize that you aren't allowed to trade them based on your laws....whenever there is large open interest, it's clear that Susquehanna is playing in our play pen....surely Ken Griffin's fingers Citadel are also involved

I'm thinking that $7.50 just has to hold....praying maybe?

[ExtremelyBullishZig]

Hopefully we get some kind of news or movement next week because this is getting ridiculous.

[BarrellofHay]

Well, one number that I really want is the (n) on the super responder group with mean improvement of -4.03. Can’t be too big though given the overall mean. The larger this group, the less improvement the remainder has. I am eduguessing about 10-15%. Did mean average calculations that show this works well. This population have a mean difference from placebo of 8. Simply amazing. Even if only 10 patients had this change, it’s truly amazing.

[bas2020]

LOCK UP THE CABAL!!!

[frrol]

While this is far from sure, I suspect we "nailed" ADCS-ADL in some credible sub-group. Support for this:

1. It had higher odds ratio than ADAS-Cog
2. It had a much better odds ratio than Emerge trial for Adu, and that was stat-sig % change signal
3. ADCS-ADL was best responding endpoint for Emerge trial for Adu
4. ADCS-ADL was best responding endpoint for our phase 2a

In other words, ADCS is a pretty easy endpoint to meet, and we and Adu have done it before, and the odds ratio is great.

People might be scratching their heads: if our ADCS odds ratio is so great, how can % change NOT be great and stat-sig? In a few words: conditionality and data distribution. Sorry, it's a statistics thing. Odds ratio is easily misleading. (It's why it's not used for gauging outcomes on its own.)

[McMagyar]

Review Resveratol clinical research and ViNIA ‘s effect

[McMagyar]

Agreed

[Hoskuld]

The company presented its findings correctly. They confirmed this. This need to monday-morning-quarterback and assume things were mis-stated or mis-represented is so...odd.

Take the company's analysis at face value and leave it at that. More details will be forthcoming.

[Investor2014]

If look at little more closely at the table you will see a column with the heading "Placebo (n=170).

[bas2020]

Put your stink bids in before you go... I've got mine in.

[Anshu2]

It’s way beyond Missling and our grievances now. It’s all about how FDA will look at the data presented to them (more complete and explained, than what has been presented to us). We may remain in dark, but that’s likely irrelevant.

Missling doesn’t seem to be in the business of being transparent. Or he has sufficient reasons to hide things.

[powerwalker]

X, I like that last two sentences. Best of luck with that and your continued improvement.

[FooBarAndGrill]

OK, was the placebo arm up-titrated or not? According to slide 24, which you posted, the placebo arm was dosed. Thus: "No placebo".

[bas2020]

LOCK UP THE CABAL!!!

[Investor2014]

Not sure what you are referring to when you say “no placebo”?

[IhidfromtheX]

In my memory, this is like the third time that a cluster has been created after a data release. Each time the signal was flashing green and continued over time. The share price gets beaten down each time and eventually the light gets solid.

[kund]

Great price to nibble, but one can wait for Christopher comfort price

[FooBarAndGrill]

I saw that and just "wow". No placebo.

[bas2020]

a lot of shares must be going through many hands.

...or perhaps just a few colluding hedge-fund computers.

[raja48185]

Are you surprised about the current pps ?

[Investor2014]

Well we are told Anavex got the data very late and that Primary Analysis could not report the 30mg and 50mg vs. placebo results given the titration flexibility to up and down adjust dose for tolerability.

Btw. were all the folks that vehemently claimed absolutely no A2-73 tolerability issues back when F1ash and other said there could be some?

So how does Missling know that all endpoints were met? And if he does know that, why not present the data that backs up that assertion?

Had Missling instead said something like: 'We go the data only very recently, so we did a quick Odds Ratio calculation in order to present something at CTAD. It is looking very promising and we will confirm with the complete results in the fullness of time'.

That would have been fine and bought us the time obviously required without creating a PR nightmare.

[Autophagy]

Aiding and abetting in my opinion.

Aiding and abetting is a legal doctrine related to the guilt of someone who aids or abets (encourages, incites) another person in the commission of a crime (or in another's suicide). It exists in a number of different countries and generally allows a court to pronounce someone guilty for aiding and abetting in a crime even if they are not the principal offender. The words aiding, abetting and accessory are closely used but have differences. While aiding means providing support or assistance to someone, committing a crime in exchange of a commission or compensation, abetting means encouraging someone else to commit a crime. Accessory is someone who in fact assists "commission of a crime committed primarily by someone else".

[Mikesc]

If you question the corruption in the SEC, look no further than FTX founder Sam Bankman. The SEC is not going to investigate this guy.... He should be in jail.

[B60611]

Agree, completely! The more I think about the seemingly illogical events of the past week, I think the most logical explanation is we narrowly missed statistical significance for the overall pool for ADCS-ADL, but the company knew we flat-out nailed 50 mg. They could reasonably state we met the endpoints, but because of the late arriving data, they couldn't furnish the breakdowns in an acceptable fashion. In such a scenario, I wonder whether the company is sure we beat .025 or .05.

Also, I still think it was very bad PR (par for the course, unfortunately) not to just say what was happening. The detractors were always going to spin, and implications of fraud are far more damaging to the company's reputation/SP, then just saying "hey guys, we nailed the 50 mg (along with everything else), you just have to wait a bit." Missling needs to do much, much better. It's unacceptable for share price to be languishing after 4 positive readouts like the ones we've had. And it does matter and is an important part of his job. Increasing transparency, and doing so conservatively, would be a very good start toward that end. Delegating to high-level Anavex folks, whom are better at particular tasks than him (some outside communication, eg) would be another welcome change.

BTW, hitting statistical significance for the pooled data is no easy task when the overall patient pool have mild/moderate ALZ, and many of them are taking donepizil (and maybe just started taking it). The possibility that donepizil interferes with Blar could make it even more impressive. In retrospect, I wish there was one arm of donepizil and one or two (30/50 mg) of donepizil naive, Anavex dosed. But I suppose it would've been too difficult/time consuming to find 510 trialees who had never taken donepizil. I must say I'm looking forward to the data for the donepizil naive / Blar 50 mg patients (as I'm sure powerwalker is as well :)), though it won't be an overly large subset. It's one of those things where the Anavex results once approved may be far more impressive than the trials, simply because there will be more folks whom had never taken donepizil.

Since this is my last post today, I want to address a reply to another post of mine:

JKS3, you said "Your thesis is wrong in terms of the rest of the patients. That's where logistic regression comes in. The regression produced a p value of significance dictates the treatment arm did overall better than the placebo arm."

To be honest, I'm a little unsure what you're saying, unless you're confusing me for the assertion I was replying to, and disagreed with, which was as follows:

"Isn’t this a poor result? I mean claiming just 25 patients (8%) of you 340 did great can never be a basis of approval —- without talking about how badly the remaining 92% did. What if the remaining 92% did WORSE than placebo on ADCS-ADL?"

[IhidfromtheX]

I'm lots better now. Blood test for outliers in early January...This will determine whether a scan or not. Sort of nice that the Cancer shows in the blood. The blood clots in the lungs are improving slowly...Dissolving the clots with blood thinners is a slow process. I keep my fingers crossed and I read some posts occasionally and will post infrequently. As I posted here once, I'm putting my life into the family. Mending fences and going forward.

[Gambit53]

SAVA yawns and the stock goes up a buck. We present what may well be the most compelling positive results regarding CNS disease of the 21st century and get sh$&@t flung at us from the four corners of the universe. Sound somewhat suspect?
Missling is unwilling to play ball with these thieves and they’ll torture him as long as possible. Unfortunately/ fortunately we’re along for the ride.

[powerwalker]

Nice to see you posting, X. Are you feeling better/improving? Prayers continue for you each morning. Hope you are back to stay.

P.S. Thanks for answering Auto.