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Someone stepped in and made a big purchase. Pfizer is not going to be the only company making a profit.
Sweet run. Low float is going to put this over $100 as the company has zero need to dilute.
Looks like it might get there today.
Looks like I didn’t buy enough.
I will add. Great run.
The evidence is mounting and this looks like the only player in town.
Damn this exceeded my expectations. Congrats to all.
Looks really nice. The wait was well worth it. Congrats
Plus the premium I made off the contracts, my real costs is in the 5’s. I will see how things progress.
Nice check. I’m in at $7 and was planning to get out at $12 but we got here so fast. I’m going let this baby roll. My grandkids will be spoiled.
It didn’t last long
Reply to
My best guess is he had another form of dementia and got better.
Less than 14 patients a month for AD. Slow enrollment in Rett.
We know AD enrollment is 450 patients and we are NOT even half way enrolled but let’s give them 224 patients. AD trial started 16 months ago. So 224 patients divided by16 months is 14 patients a month at best. Just 14 patients a month and Missling is bragging about historical enrollment.
A CEO bragging about this enrollment should be fired.
He knew he could not complete enrollment with the sites available THIS Delay is on purpose.
Something is wrong with AD efficacy.
Add in conducting AD in location know for Slow trials for AD.
Then factor a trial that is twice as long as it needs to be.
SOC got approved with a trial half as long by the FDA.
This trial is being purposefully delayed or Missling is horrible at math.
Report TOS
Moderate
We know AD enrollment is 450 patients and we are NOT even half way enrolled but let’s give them 224 patients. AD trial started 16 months ago. So 224 patients divided by16 months is 14 patients a month at best. Just 14 patients a month and Missling is bragging about historical enrollment.
A CEO bragging about this enrollment should be fired.
He knew he could not complete enrollment with the sites available THIS Delay is on purpose.
Something is wrong with AD efficacy.
Add in conducting AD in location know for Slow trials for AD.
Then factor a trial that is twice as long as it needs to be.
SOC got approved with a trial half as long by the FDA.
This trial is being purposefully delayed or Missling is horrible at math.
Not. Some Participants had an MRI and not a pet.
Some of the 32 not having Alzheimer’s is a reasonable theory
Reply to investor.....
the outliers that achieved strong response with near no A2-73 concentration and those who had low response despite high concentration.
I guess the inclusion criteria for the trials does not matter. What you stated is not and has not has never been included in any of the inclusion criteria for the 32 and in extended trials.
Reply to,
Something is wrong with AD
We know AD enrollment is 450 patients and we are NOT even half way enrolled but let’s give them 224 patients. AD trial started 16 months ago. So 224 patients divided by16 months is 14 patients a month at best. Just 14 patients a month and Missling is bragging about historical enrollment.
A CEO bragging about this enrollment should be fired.
He knew he could not complete enrollment with the sites available THIS Delay is on purpose.
Something is wrong with AD efficacy.
Add in conducting AD in location know for Slow trials for AD.
Then factor a trial that is twice as long as it needs to be.
SOC got approved with a trial half as long by the FDA.
This trial is being purposefully delayed or Missling is horrible at math.
It was not in the inclusion criteria and has never been in the inclusion criteria and to suggest it is wishful thinking.
All 32 did not have a PET. The foundation of the drug is not solid If the participants don’t have Alzheimer’s.
Again 32 was 5 years ago. Foundation is questionable and what’s being constructed is subject to collapse.
More information to suggest the 32 patients did not have Alzheimer’s. Some of the 32 had just a MRI.
BP does a better job of screening patients per article and there trials have a lot more participants.
Reply toSomething is wrong with AD
We know AD enrollment is 450 patients and we are NOT even half way enrolled but let’s give them 224 patients. AD trial started 16 months ago. So 224 patients divided by16 months is 14 patients a month at best. Just 14 patients a month and Missling is bragging about historical enrollment.
A CEO bragging about this enrollment should be fired.
He knew he could not complete enrollment with the sites available THIS Delay is on purpose.
Something is wrong with AD efficacy.
Add in conducting AD in location know for Slow trials for AD.
Then factor a trial that is twice as long as it needs to be.
SOC got approved with a trial half as long by the FDA.
This trial is being purposefully delayed or Missling is horrible at math.
You might be right.
Not to swift are you.
Negative sentiment it reads.
Obvious you are not swift enough to trade options.
https://fintel.io/so/us/avxl
Here’s a link from fintel.
If you read the section about options you will note it clearly states puts options are a negative sentiment.
Less than 14 patients a month and each site has diminishing returns.
I see why AD enrollment figures are not released.
Bad leadership.
Missling knew there were not enough sites. And waited over a year to announce adding more.
Gross negligence.
https://www.hammond.com.au/documents/research-reports/404-2018-hammondcare-researchreport/file
Read page 38.
Raja. Point made but my investment in Anavex is reduced.
Opportunity costs too great.
July trifecta right.
Hard to believe what Missling leads one to believe.
Missling stated “We are planning to power the study”
I know we lies a lot and we don’t know when to believe him or not believe him.
Missling is planning to power which implies current trial NOT enough power.
It’s correct. Let me be clear. I view it as a weakness to add more power.
Could also be viewed as lack of expected efficacy based upon current trial participants.
Could also be viewed as lack of expected efficacy based upon current trial participants.
More power is needed.
Quote, “we are planning”
Means there’s not enough. Pretty simple and rudimentary.
CEO negligence.
He knew there were not enough sites. And waited over a year to announce adding more.
Gross negligence.
https://www.hammond.com.au/documents/research-reports/404-2018-hammondcare-researchreport/file
Read page 38. It was clear last year there were not enough sites to complete AD enrollment.
No Link to support subjective statement. And Missling is a fool for waiting to add more sites when it was clear from McFarlane there would not be enough patients.
Pure negligence from a CEO.
Lol. Link please
Reply to
The TGA is the only one with the right to mention provisional approval. When they do it will be a done deal.
No provisional approval. Period.
Zhong
Okay and then given that this is the third study with quite meaningful number of patients close to 70 patients for an orphan [ph] indication, what's the potential assuming that that data are positive with the potential for the study to serve as a pivotal study?
Christopher Missling
Which one, if I may ask?
Yun Zhong
The pediatric study.
Christopher Missling
Yes, so we are planning and this is still to be confirmed. But given that we have knowledge about design for this indication, we are planning to power the study so this could become and could be sufficiency as a pivotal study and the two additional studies in adult Rett syndrome would be obviously also utilized as supported for that strategy.
Power means need more patients.
Hi, thanks for taking the questions. So two questions on the Rett syndrome program. Are you waiting for initial data from the Phase 2 study and Australian study before you will initiate the pediatric study? If not and what will be the limiting steps that you will have to complete before you will be able to initiate the pediatric study?
Christopher Missling
So we are not really waiting for that, but there is certainly a chance that this will overlap a little bit, so but there's not like a dependency directly correlated.
Another trial is forthcoming and no mention of provisional approval.
It’s in the q and a.
Wow. “We are planning to power the study”
Means more patients. If the plan is to add more patients, provisional approval not forthcoming.
Wrong. When Missling stated this,,,
It means more trials or adding a lot more patients.
Quote from Missling today.
Yes, so we are planning and this is still to be confirmed. But given that we have knowledge about design for this indication, we are planning to power the study so this could become and could be sufficiency as a pivotal study and the two additional studies in adult Rett syndrome would be obviously also utilized as supported for that strategy.
https://www.hammond.com.au/documents/research-reports/404-2018-hammondcare-researchreport/file
Read page 38 for delays that were already announced for AD.
Diminishing returns is accurate.
Australia has zero control over sites that might open outside of that country. Zero.
Lol. Enrollment is slow that’s the point.
Wrong. Mcfly’s article made it very clear. Enrollment was not going to happen with the sites they had in Australia.
Trial is 450 patients. First patient dosed 8/28/18. Recruiting at 16 sites. Other sites enroll 7 to 10 patients. #1 site is at 31 goal is 50. Dr said recruiting will go into early 2021.
Math not adding up to 450.
Give #1 site 50 which is top end of goal.
Give the other 15 sites top end of their goal of 10 for 150 total.
That’s only 200 patients total.
Looks like we are 250 patients short and again Dr has already admitted recruiting in 2021.
Sorry this news is not good. Drs math is not adding up.
ANAVEX trial- A phase 2b/3, double-blind, randomised, placebocontrolled 48-week safety and efficacy trial of ANAVEX2-73 for the
treatment of Alzheimer’s disease
Associate Professor Macfarlane’s study team has been
involved in testing the ANAVEX2-73 molecule since 2014
and were heavily involved in writing and editing the
previous phase 2a, and current phase 2b/3, protocols.
ANAVEX2-73 is a novel compound that is thought to act on
the sigma 1 intracellular receptor.
Its mode of action is unique in that most (if not all) other
molecules developed thus far to treat Alzheimer’s Disease target
the removal of a single type of toxic protein (either beta amyloid
or Tau). In contrast, ANAVEX2-73 is thought to remove all forms of
misfolded proteins from brain cells.
While involved in the phase 2a study, Associate Professor
Macfarlane and his team saw positive (and at times drastic)
increases in cognition and functioning in study participants, and
are pleased to be involved in the phase 2b/3 study. The study will be
recruiting throughout 2019 and most likely 2020 and into early 2021.
Some key achievements of the HammondCare site in relation to
this study include:
1. Associate Professor Stephen Macfarlane has been appointed
as the global study lead for this study
2. The Malvern site was the first site in the world to be initiated
3. Ours is the global No.1 recruiting site (most sites average 7-10
patients per study, whilst Malvern already has 31 patients on
study and aims to recruit 40-50 patients)
4. This trial is currently being conducted at over 15 sites globally
and will run for another 24 months
I guess pushing back completion dates on clinic...gov means enrollment is ahead of pace.
I guess not having a set target date for AD enrollment means it is ahead of pace.
We posted this in August.
Anavex having problems recruiting in AD.
Trial is 450 patients. First patient dosed 8/28/18. Recruiting at 16 sites. Other sites enroll 7 to 10 patients. #1 site is at 31 goal is 50. Dr said recruiting will go into early 2021.
Math not adding up to 450.
Give #1 site 50 which is top end of goal.
Give the other 15 sites top end of their goal of 10 for 150 total.
That’s only 200 patients total.
Looks like we are 250 patients short and again Dr has already admitted recruiting in 2021.
Sorry this news is not good. Drs math is not adding up.
ANAVEX trial- A phase 2b/3, double-blind, randomised, placebocontrolled 48-week safety and efficacy trial of ANAVEX2-73 for the
treatment of Alzheimer’s disease
Associate Professor Macfarlane’s study team has been
involved in testing the ANAVEX2-73 molecule since 2014
and were heavily involved in writing and editing the
previous phase 2a, and current phase 2b/3, protocols.
ANAVEX2-73 is a novel compound that is thought to act on
the sigma 1 intracellular receptor.
Its mode of action is unique in that most (if not all) other
molecules developed thus far to treat Alzheimer’s Disease target
the removal of a single type of toxic protein (either beta amyloid
or Tau). In contrast, ANAVEX2-73 is thought to remove all forms of
misfolded proteins from brain cells.
While involved in the phase 2a study, Associate Professor
Macfarlane and his team saw positive (and at times drastic)
increases in cognition and functioning in study participants, and
are pleased to be involved in the phase 2b/3 study. The study will be
recruiting throughout 2019 and most likely 2020 and into early 2021.
Some key achievements of the HammondCare site in relation to
this study include:
1. Associate Professor Stephen Macfarlane has been appointed
as the global study lead for this study
2. The Malvern site was the first site in the world to be initiated
3. Ours is the global No.1 recruiting site (most sites average 7-10
patients per study, whilst Malvern already has 31 patients on
study and aims to recruit 40-50 patients)
4. This trial is currently being conducted at over 15 sites globally
and will run for another 24 months.
Delays Delays Delays
Original PR in 2018 stated North American site.
McFarlane stated in an article
The study will be
recruiting throughout 2019 and most likely 2020 and into early 2021.
Some key achievements of the HammondCare site in relation to
this study include:
1. Associate Professor Stephen Macfarlane has been appointed
as the global study lead for this study.,,,,,,,
Raja, Another RS coming,
That’s good for investors right.
If 100% of patients are enrolling into the extension study. Placebo and drug enrollments are performing at the same pace.