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Posted On: 09/02/2017 8:36:16 AM
Post# of 1460
Another good post (IMHO) copied,
Fletch
polarbear77 Friday, 09/01/17 12:19:37 PM
Re: XenaLives post# 118170
Post # of 118273
“Buy and add” as you say, Xena, and WAIT to see:
1) If the company hired a 24 year FDA veteran “to manage the considerable number of regulatory filings that Anavex has planned” because they actually have a compound that has illustrated very promising efficacy in a number of different CNS indications? Or whether they simply wanted another face around the office.
2) If they’re planning to release further trial PK/PD data from Ariana with genomic analysis as their next stated objective in their August SEC filing? Or whether that was just a typo.
3) If our CEO has been making insider purchases on Forms S-4 over the past 3-4 weeks because he has inherent CONFIDENCE in the future prospects of the Company and the results that its compound(s) are illustrating during the trial extensions? Or whether he enjoys filling out SEC regulatory forms just so that he can buy a few shares for stocking stuffers this December?
4) If the Company thought it would simply be enjoyable to contract with a world-class team of international patent attorneys to painstakingly document and protect its IP in a wide range of indications and chemical formulations during a process that must have utilized a tremendous amount to time and Company resources? Or instead that they have internally-available and SAB-reviewed trial results that have convinced them that they are onto something big here and it’s very much worth protecting?
5) If the Company and its well-respected CEO and SAB and BOD and partnering organizations and PI in Australia will soon share their underlying 18 month trial data/results that they are assumably using to make straight-forward and definitive statements about the effects that the a2-73 compound is illustrating on its Phase 2 trial extension participants, such as providing “dose dependent cognitive improvement” and that the compound “restores cellular homeostasis” without any forward-looking statements or required SEC disclosure or qualifiers or hedging words (that I can find) with the upcoming September CNS conference abstract (due your own DD)? Or whether one should absurdly assume that they cannot sufficiently substantiate said affirmative and definitively-worded claims?
6) If there’s been an apparent quiet period on further data releases since early 2017 because of positive reasons and competitive reasons and confirmatory data analysis reasons? Or whether it will be shown that all of the collective parties involved in the testing/analysis/review (such as our SAB and legal team and the various independent researchers/universities/governments/regulators/hospitals and outside experts such as Dr George Perry) have all simply decided to play along with a strategy of not releasing new data because perhaps it’s not trending upward any longer or perhaps the test scores are no longer stabilizing and that they all collectively believe it would be appropriate to continue to present the Dec 2016 12-month positive results and upsloping results during the recent June 2017 presentation to the investment community? I’d prefer to believe that they would not do that.
7) If perhaps the apparent quiet period has been as a result of awaiting new 21st CCA new FDA guidance and trial protocols to begin in September 2017?
If perhaps the apparent quiet period has been as a result of our new hire’s guidance and assistance with FT/BT/AA applications and designations with the FDA?
9) If the medical media or biotech analysts have any interest in communicating to the general public about a Company that is asserting that their compound is providing cognitive improvement in a dose-dependent manner to sufferers of mild to moderate Alzheimer’s disease (n=25), and that it also is restoring cellular homeostasis (which has apparently a multitude of health benefits)? Or whether that’s really not to be believed (because surely there’s other explanations as to how this group of 25 stabilized/improved on their own, or that maybe they put coconut oil in their morning smoothies) and the public is not sophisticated enough to understand these new treatment concepts & new developments, and that the public is just better off on the current SOC and its relatively ineffectiveness?
10) If it’s also simply a modern miracle that 8 out of 8 of our trial participants that started with insomnia systems were without said insomnia symptoms at the end of the 1st trial extension? Or perhaps it had something to do with the 2-73 compound “restoring cellular homeostasis”? Could that be?
11) If perhaps the real-world comments and perspectives (after a year of non-optimized dosage) of our trial participants' caregivers (pasted below) were really just some perceived placebo effects? Or whether reading more books and regaining piano skills, doing more housework, resuming painting, writing more letters, playing golf again, etc, are actually not very likely to occur in mild to moderate Alzheimer’s patients that are popping a sugar pill?
12) Whether the change in language (more robustly worded now) by Dr Francardo (independent Parkinson’s disease researcher associated with the MJF Foundation) in her May 2018 presentation summary is by design? She now states that "Our results reveal that ANAVEX 2-73 is able to ameliorate parkinsonian motor symptoms" AND "exerts neuroprotective/neurorestorative effects on the nigrostriatal dopamine system". Whereas in 2016 her poster at the World Parkinson Congress indicated primarily: “These results demonstrate that ANAVEX 2-73 has robust neurorestorative effects on the nigrostriatal DA pathway. The effects observed are consistent with those produced by the selective s-1R receptor agonist PRE-084 in a previous study (Francardo et al, Brain 2014, 137 (Pt 7): 1998-2014)”. The summary conclusions & results appear more robust and positive now from Dr. Francardo; at least to yours truly.
13) If the Company decided to add Multiple Sclerosis to its discussion points at the upcoming CNS Partnering Conference in 10 days because they have news or developments to report? Or whether they wanted to voluntarily bring to everyone’s attention that “we really can’t seem to make any headway with this difficult to treat MS indication, however please do hand out our business cards if you’ve any family or friends working at Big Pharma because we’d love to brainstorm with them one day”……
14) Whether or not the scientists and researchers with ties to the BP research billions over the last 20-30 years will be willing and able to embrace/endorse/lend credence to (what I expect must be) upcoming 18 month trial results reflecting the Company’s statements of “dose dependent cognitive improvement” and “restores cellular homeostasis”? How quickly can or will the tau protein/tangles removal theory be set aside by those who have been pushing/promoting/testing it? Will pride or hubris play a factor?
15) Has “the market” been correct to place a current valuation on this Company (at approx. the value of a company only serving 15% of the insomnia market)?
16) If it’s been reasonable for me to assume that the Company’s early promising results have been enough to cause the current CNS space and those heavily-invested in current treatment options (billions at stake) to mute any positive press/analyst coverage of a2-73 thereby providing no outward public acknowledgement of a2-73 and its MOA? Or have I been irrationally hysterical re same?
17) Have I been foolish to consider the above factors along with common sense and deductive logic to invest here prior to further confirmatory evidence/announcements? I pray not.
Everyone can make their own decisions and do their own DD as I'm long the stock and therefore I’ve a bias; and I’m not strong at science; just my opinions and observations. GLTAL
Excerpted from Jefferies slide from June 2017:
"PATIENT EVENTS: THERAPEUTIC RESPONSE UNEXPECTED
101001 MORE ALERT REGARDING SURROUNDINGS
101002 FEELS MUCH HAPPIER MAKING JOKES
101003 MUCH HAPPIER WHEN ATTENDING CLINIC APPTS AND ENJOYS MAKING JOKES
AND ENGAGES WELL IN CONVERSATION
101004 BETTER HAND COORDINATION. CALMER AND MORE COMMUNICATIVE
101006 IMPROVING MOODS. READING MORE BOOKS
101007
ABILITY TO PLAY THE PIANO AND READ MUSIC NOTES AT ABOUT 9 MONTHS
INTO TRIAL. SHE USED TO PLAY THE PIANO AT AGE 5 AND LOST HER ABILITY PREALZHEIMER
TRIAL
101010 ABLE TO FOLLOW PLOT WHEN WATCHING MOVIES WHEREAS PREVIOUSLY
COULD NOT
101010 MORE COMPASSION FOR CHILDREN
101011 WIFE THINKS PATIENT IS A BIT MORE CHEERFUL
101013 ABLE TO DO MUCH MORE HOUSEWORK THAN BEFORE
101013 MORE DRIVEN AND UPBEAT LESS ANXIOUS ACCORDING TO CARER
101014
AN INTERNATIONAL ARTIST WHO RESUMED HER PAINTING ABILITIES AND NOW
HAVING AN EXHIBITION IN NOV 2016. WRITTEN A 3 PAGE LETTER TO LONG LOST
BROTHER
101015 PLAYING MORE GOLF NOW BY HIMSELF. MORE CONFIDENT AT GOING OUT BY
HIMSELF
101017 ENJOYED HER TRIP TO BELGIUM - TALKS ABOUT SOME BITS OF HER TRIP
102001 IMPROVED ENGAGEMENT WITH FAMILY/FRIENDS/OUTSIDE WORLD
102008 IMPROVEMENT IN MOOD
102010 FEELING GREAT - IMPROVEMENT IN COGNITION AND MOOD, BALANCE AND
GAIT HAS IMPROVED
103001 PATIENT REMEMBERING SOMETHING HE WOULDN'T HAVE PREVIOUSLY"
Fletch
polarbear77 Friday, 09/01/17 12:19:37 PM
Re: XenaLives post# 118170
Post # of 118273
“Buy and add” as you say, Xena, and WAIT to see:
1) If the company hired a 24 year FDA veteran “to manage the considerable number of regulatory filings that Anavex has planned” because they actually have a compound that has illustrated very promising efficacy in a number of different CNS indications? Or whether they simply wanted another face around the office.
2) If they’re planning to release further trial PK/PD data from Ariana with genomic analysis as their next stated objective in their August SEC filing? Or whether that was just a typo.
3) If our CEO has been making insider purchases on Forms S-4 over the past 3-4 weeks because he has inherent CONFIDENCE in the future prospects of the Company and the results that its compound(s) are illustrating during the trial extensions? Or whether he enjoys filling out SEC regulatory forms just so that he can buy a few shares for stocking stuffers this December?
4) If the Company thought it would simply be enjoyable to contract with a world-class team of international patent attorneys to painstakingly document and protect its IP in a wide range of indications and chemical formulations during a process that must have utilized a tremendous amount to time and Company resources? Or instead that they have internally-available and SAB-reviewed trial results that have convinced them that they are onto something big here and it’s very much worth protecting?
5) If the Company and its well-respected CEO and SAB and BOD and partnering organizations and PI in Australia will soon share their underlying 18 month trial data/results that they are assumably using to make straight-forward and definitive statements about the effects that the a2-73 compound is illustrating on its Phase 2 trial extension participants, such as providing “dose dependent cognitive improvement” and that the compound “restores cellular homeostasis” without any forward-looking statements or required SEC disclosure or qualifiers or hedging words (that I can find) with the upcoming September CNS conference abstract (due your own DD)? Or whether one should absurdly assume that they cannot sufficiently substantiate said affirmative and definitively-worded claims?
6) If there’s been an apparent quiet period on further data releases since early 2017 because of positive reasons and competitive reasons and confirmatory data analysis reasons? Or whether it will be shown that all of the collective parties involved in the testing/analysis/review (such as our SAB and legal team and the various independent researchers/universities/governments/regulators/hospitals and outside experts such as Dr George Perry) have all simply decided to play along with a strategy of not releasing new data because perhaps it’s not trending upward any longer or perhaps the test scores are no longer stabilizing and that they all collectively believe it would be appropriate to continue to present the Dec 2016 12-month positive results and upsloping results during the recent June 2017 presentation to the investment community? I’d prefer to believe that they would not do that.
7) If perhaps the apparent quiet period has been as a result of awaiting new 21st CCA new FDA guidance and trial protocols to begin in September 2017?
If perhaps the apparent quiet period has been as a result of our new hire’s guidance and assistance with FT/BT/AA applications and designations with the FDA? 9) If the medical media or biotech analysts have any interest in communicating to the general public about a Company that is asserting that their compound is providing cognitive improvement in a dose-dependent manner to sufferers of mild to moderate Alzheimer’s disease (n=25), and that it also is restoring cellular homeostasis (which has apparently a multitude of health benefits)? Or whether that’s really not to be believed (because surely there’s other explanations as to how this group of 25 stabilized/improved on their own, or that maybe they put coconut oil in their morning smoothies) and the public is not sophisticated enough to understand these new treatment concepts & new developments, and that the public is just better off on the current SOC and its relatively ineffectiveness?
10) If it’s also simply a modern miracle that 8 out of 8 of our trial participants that started with insomnia systems were without said insomnia symptoms at the end of the 1st trial extension? Or perhaps it had something to do with the 2-73 compound “restoring cellular homeostasis”? Could that be?
11) If perhaps the real-world comments and perspectives (after a year of non-optimized dosage) of our trial participants' caregivers (pasted below) were really just some perceived placebo effects? Or whether reading more books and regaining piano skills, doing more housework, resuming painting, writing more letters, playing golf again, etc, are actually not very likely to occur in mild to moderate Alzheimer’s patients that are popping a sugar pill?
12) Whether the change in language (more robustly worded now) by Dr Francardo (independent Parkinson’s disease researcher associated with the MJF Foundation) in her May 2018 presentation summary is by design? She now states that "Our results reveal that ANAVEX 2-73 is able to ameliorate parkinsonian motor symptoms" AND "exerts neuroprotective/neurorestorative effects on the nigrostriatal dopamine system". Whereas in 2016 her poster at the World Parkinson Congress indicated primarily: “These results demonstrate that ANAVEX 2-73 has robust neurorestorative effects on the nigrostriatal DA pathway. The effects observed are consistent with those produced by the selective s-1R receptor agonist PRE-084 in a previous study (Francardo et al, Brain 2014, 137 (Pt 7): 1998-2014)”. The summary conclusions & results appear more robust and positive now from Dr. Francardo; at least to yours truly.
13) If the Company decided to add Multiple Sclerosis to its discussion points at the upcoming CNS Partnering Conference in 10 days because they have news or developments to report? Or whether they wanted to voluntarily bring to everyone’s attention that “we really can’t seem to make any headway with this difficult to treat MS indication, however please do hand out our business cards if you’ve any family or friends working at Big Pharma because we’d love to brainstorm with them one day”……
14) Whether or not the scientists and researchers with ties to the BP research billions over the last 20-30 years will be willing and able to embrace/endorse/lend credence to (what I expect must be) upcoming 18 month trial results reflecting the Company’s statements of “dose dependent cognitive improvement” and “restores cellular homeostasis”? How quickly can or will the tau protein/tangles removal theory be set aside by those who have been pushing/promoting/testing it? Will pride or hubris play a factor?
15) Has “the market” been correct to place a current valuation on this Company (at approx. the value of a company only serving 15% of the insomnia market)?
16) If it’s been reasonable for me to assume that the Company’s early promising results have been enough to cause the current CNS space and those heavily-invested in current treatment options (billions at stake) to mute any positive press/analyst coverage of a2-73 thereby providing no outward public acknowledgement of a2-73 and its MOA? Or have I been irrationally hysterical re same?
17) Have I been foolish to consider the above factors along with common sense and deductive logic to invest here prior to further confirmatory evidence/announcements? I pray not.
Everyone can make their own decisions and do their own DD as I'm long the stock and therefore I’ve a bias; and I’m not strong at science; just my opinions and observations. GLTAL
Excerpted from Jefferies slide from June 2017:
"PATIENT EVENTS: THERAPEUTIC RESPONSE UNEXPECTED
101001 MORE ALERT REGARDING SURROUNDINGS
101002 FEELS MUCH HAPPIER MAKING JOKES
101003 MUCH HAPPIER WHEN ATTENDING CLINIC APPTS AND ENJOYS MAKING JOKES
AND ENGAGES WELL IN CONVERSATION
101004 BETTER HAND COORDINATION. CALMER AND MORE COMMUNICATIVE
101006 IMPROVING MOODS. READING MORE BOOKS
101007
ABILITY TO PLAY THE PIANO AND READ MUSIC NOTES AT ABOUT 9 MONTHS
INTO TRIAL. SHE USED TO PLAY THE PIANO AT AGE 5 AND LOST HER ABILITY PREALZHEIMER
TRIAL
101010 ABLE TO FOLLOW PLOT WHEN WATCHING MOVIES WHEREAS PREVIOUSLY
COULD NOT
101010 MORE COMPASSION FOR CHILDREN
101011 WIFE THINKS PATIENT IS A BIT MORE CHEERFUL
101013 ABLE TO DO MUCH MORE HOUSEWORK THAN BEFORE
101013 MORE DRIVEN AND UPBEAT LESS ANXIOUS ACCORDING TO CARER
101014
AN INTERNATIONAL ARTIST WHO RESUMED HER PAINTING ABILITIES AND NOW
HAVING AN EXHIBITION IN NOV 2016. WRITTEN A 3 PAGE LETTER TO LONG LOST
BROTHER
101015 PLAYING MORE GOLF NOW BY HIMSELF. MORE CONFIDENT AT GOING OUT BY
HIMSELF
101017 ENJOYED HER TRIP TO BELGIUM - TALKS ABOUT SOME BITS OF HER TRIP
102001 IMPROVED ENGAGEMENT WITH FAMILY/FRIENDS/OUTSIDE WORLD
102008 IMPROVEMENT IN MOOD
102010 FEELING GREAT - IMPROVEMENT IN COGNITION AND MOOD, BALANCE AND
GAIT HAS IMPROVED
103001 PATIENT REMEMBERING SOMETHING HE WOULDN'T HAVE PREVIOUSLY"
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