I’ll bet you two beer that he has been tapping LPC, which is not shares directly sold to the public because LPC is the middle man.

The honesty and thoroughness of the statistics from individual governments certainly makes accurate comparisons difficult, but clicking through these by country, it looks to me like the countries that locked down have changed when the infections occur, not if they occur. Now allowing time to develop therapeutics like President Trump received may indeed end up lowering the fatality rate but not the total number of cases imho.




https://srv1.worldometers.info/coronavirus/#countries






https://duckduckgo.com/?q=flatten+the+curve&t=iphone&iax=images&ia=images&iai=https%3A%2F%2Fplaneta.com%2Fwp-content%2Fuploads%2F2020%2F03%2Fflattenthecurve-1024x768.jpg

The ocean prevented airborne particles from infecting people on the other side of the ocean. What happened when someone crossed the ocean and exposed the population with no immunity to the virus? The same thing will happen with masks unless we wear them in perpetuity. Should we do that?

Yes. Does that prevent someone from getting Wuhan virus or does it change the timeframe when they get the virus?

Will Sweden have a second wave? Why not?

Why do you think there was a conspiracy? I didn’t say that. CM was brought in to rescue Anavex’s finances. He has done a great job. It’s not illegal to set a timeline and miss it, is it? If I recall correctly, he raised money previously when he promised all those trials by year end and he knew good and well that was not going to happen. I also didn’t say he was hiding “bad” results.

And that floor will also take into account the amount of cash on hand. Based on previous behavior, I believe it’s a safe bet to anticipate that CM is using his self imposed catalyst timeline to fill the coffers through LPC prior to a read out.



That would be the prudent course of action IMHO.

An as yet unknown portion (possibly all) of the patients in the PDD trial may be taking the current SOC drugs for the disease .
(I believe the same is true for the AZ trial as well)


“Stable regimen of anti-Parkinson's disease medications (including levodopa, dopamine agonists, MAO-B inhibitors, or the COMT inhibitor entacapone), which has been stable for at least 4 weeks prior to Baseline.

Treatment with cholinesterase inhibitor (rivastigmine, donepezil and galantamine (Exelon®, Aricept®, or Reminyl®) will be permitted, provided the dose has been stable for a minimum of 8 weeks prior to randomization.

Subjects with history of depression on antidepressant medications will be allowed if depression is controlled and they have been on a stable daily dose of the antidepressant for ≥8 weeks before Baseline.”


https://clinicaltrials.gov/ct2/show/NCT03774459?term=Anavex&draw=2&rank=6


“Cholinesterase inhibitors — drugs that are the current mainstay for treating cognitive changes in Alzheimer's — may help Parkinson's disease dementia symptoms, including visual hallucinations, sleep disturbances and changes in thinking and behavior.

Antipsychotic drugs — a drug category sometimes prescribed for behavioral symptoms of Alzheimer’s — should be used with extreme caution because they may cause serious side effects in up to 50% of those with Parkinson’s disease dementia or Lewy body dementia. Side effects may include sudden changes in consciousness, impaired swallowing, acute confusion, episodes of delusions or hallucinations, or appearance or worsening of Parkinson’s symptoms.

Treating movement symptoms in those with Parkinson’s dementia can be challenging, because carbidopa-levodopa — the chief treatment for Parkinson’s movement symptoms — can sometimes aggravate hallucinations and confusion in those with Parkinson’s dementia or Lewy body dementia.”


https://www.alz.org/alzheimers-dementia/what-is-dementia/types-of-dementia/parkinson-s-disease-dementia

Well 33% of the patients in the trial are on placebo. Why did they elect to continue? Were they seeing improvement?

“And also, it will definitely be this quarter. I don't want to go in more specifics. We will report exactly when we have the data. .”

https://seekingalpha.com/article/4366822-anavex-life-sciences-corp-avxl-ceo-dr-christopher-missling-on-q3-2020-results-earnings-call

Definitely coming in the next 16 day unless Anavex’s quarter doesn’t end in September. Is there another way to divide the calendar quarterly?

“And also, it will definitely be this quarter. I don't want to go in more specifics. We will report exactly when we have the data. .”

https://seekingalpha.com/article/4366822-anavex-life-sciences-corp-avxl-ceo-dr-christopher-missling-on-q3-2020-results-earnings-call

It’s getting close. Good luck.

“Charles Duncan

Okay. And I think you mentioned that data should be by the end of September?

Dr. Christopher Missling

We said this quarter. And also, it will definitely be this quarter. I don't want to go in more specifics. We will report exactly when we have the data. .”


https://seekingalpha.com/article/4366822-anavex-life-sciences-corp-avxl-ceo-dr-christopher-missling-on-q3-2020-results-earnings-call

https://www.businessinsider.com/elon-musk-tesla-semi-truck-electric-18-wheeler-rig-tech-driving-road-2017-11?utm_source=facebook.com&utm_medium=social&utm_campaign=sf-bi-cars&fbclid=IwAR2jrNdKKeZXD5PqEw--4p-IbPRWtVRwJUwlgZ7V8-4VZUFbz_XHqSfpokI&jwsource=cl

Thoughts?

Down = Cabal
Up = News leak

“A Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Study of ANAVEX2-73 in Patients With Rett Syndrome”

In other words, the mother has no idea if any improvements she notices are from the drug or if she is only perceiving benefits because she wants desperately for something to work. That’s the purpose of a placebo controlled trial. Hopefully A2-73 works.

Well of course, but having money invested in Anavex and wanting the stock price to increase also has a significant effect on the meaning of the SAS approval. I mean any doctor who knew about A2-73 could/should have told their patient to register for the clinical trial, but instead, they waited for this SAS approval because...well you know...it will be good for Anavex’s stock price.

Was it a buy or a sell, or both?

Would you please show the link to your source for that statement? I have never been able to find anything that states that.

That’s roughly the same message the IR person at NTRP gave me. I would take that info with a silo of salt.

When that data does finally come out it might be more useful than the results revealed so far because MMSE is unreliable for anything under 3 years. What’s strange about your theory of trial end requiring a SAS is that the trial doesn’t end till November. Perhaps it took 4 months to recruit the 32 patients?

Estimated Primary Completion Date :
November 2020
Estimated Study Completion Date :
November 2020


I would personally add the fact that Anavex has only revealed the 148 week data to the negative side of the ledger because they should have data in hand that is beyond the 3 year unreliable mark. Why haven’t they revealed those results if they would be encouraging for investors?

Score from MMSE (Mini-mental state examination score) [ Time Frame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208 ]

https://wsw.com/webcast/cc/avxl14.

Anavex’s drug was purchased under the stewardship of someone who formed a biotech company with little to no apparent biotech experience. It was purchased for a paltry sum of money after lying dormant on the shelf for much of it’s patent life. It’s publicized MOA is Sigma1 activation. Sigma1 activation is not “cutting edge”, lots of other drugs activate Sigma1, many even have a much higher affinity than A2-73. Anavex was in dire straits financially before DrM was brought onboard.

IMHO, investors should be thanking their lucky stars for DrM. Almost 30 million in the bank, trials underway, and a market cap of 1/4 billion dollars on the thinnest of hopes from a long shot drug with an extremely questionable pedigree. Where would Anavex be without DrM?

An insurance company would probably deny payment for an unproven drug. Perhaps government run programs might be willing to pay. I suspect almost all doctors, outside of those involved with the current trial, would wait for actual proof of efficacy before prescribing A2-73.

That’s a correct interpretation of the latest announcement imho. It’s most likely that Professor Stephen Macfarlane filed the paperwork for permission to continue giving A2-73 to the participants of the 2a unblinded trial after it ends in November. That permission was granted to whichever doctor requested it. Nothing more, nothing less.

Probably requested by Principal investigator Professor Stephen Macfarlane, head of HammondCare clinical services?

Special Access Scheme: frequently asked questions


“Category B is an application pathway which can be accessed by health practitioners for patients that do not fit the Category A definition and where the unapproved good is not deemed to have an established history of use and cannot therefore be accessed through Category C. An approval letter from TGA is required before the good may be accessed. Approvals for medicines accessed through this pathway are typically only issued to medical and dental practitioners.

“Who can apply for access to therapeutic goods via the SAS pathways?


“Applications and notifications made under the SAS pathways are completed and submitted by registered health practitioners, preferably the prescribing health practitioner, who is best placed to determine the needs of the patient, including whether or not treatment with a particular product is required. It is expected that, in accordance with good medical practice, a health practitioner will educate themselves with all relevant and available information about a therapeutic good before using it.”


“What is the process for submitting a Category B application form?


The prescribing health practitioner or someone acting on their behalf can submit an application to the TGA to gain access to an unapproved therapeutic good for a patient that does not fit the Category A definition. Approval of an application to supply a product is required from a delegate in the TGA. Approval by the TGA is given on a patient-by-patient basis to reflect the needs of different patients. Applications can be made by lodging a completed Category B application form with the TGA).



https://www.tga.gov.au/special-access-scheme-frequently-asked-questions

You can spot this amount of dilution?


“the Regular Purchase Share Limit may be increased to up to 225,000 shares if the closing price of our common stock is not below $4.00”

Today is yesterday’s tomorrow, is dilution occurring?

Your possibly correct. However, unless LPC has been holding previous purchases, their supply is limited and could be piecemealed throughout the day.


Under the Amended Purchase Agreement, we may, from time to time until July 1, 2022, in our sole discretion and subject to certain conditions outside of Lincoln Park’s control, direct Lincoln Park to purchase up to 200,000 shares (the “Regular Purchase Share Limit”) of our common stock on any business day (each such purchase, a “Regular Purchase”); provided that (i) the Regular Purchase Share Limit may be increased to up to 225,000 shares if the closing price of our common stock is not below $4.00 on such date and ...

Now I see it. Wasn’t wearing my tinted glasses.

Perhaps you can explain to me how you are able to tell when LPC is reselling their shares? As long as a stocks volume remains adequate, then the dilution is intentionally covert. Not saying dilution is or is not happening, just questioning how you are able to state definitively that it’s not occurring. Your aware of the purchase limit restrictions on the LPC agreement, correct?

Unless your referring to the so far unused Cantor ATM, then investors cannot tell if there is dilution on the day Anavex “puts” the shares to LPC because that transaction is between Anavex and LPC. It’s not until the following day that LPC generally resells those shares they purchased into the markets.

Perhaps the best way to create excitement is to only present the financial data and then mention how close they are to having the PDD results. Stoke the anticipation, so to speak.

Possibly the cash position will be even stronger on this filing as well.

Does anyone here think the doses are only 10 and 20 mgs or is everyone convinced they are using 30 and 50 mgs?

Well from my limited experience with other biotechs, not raising as much money as possible before trial results was a mistake. Say for instance the trial results are disappointing, would that be a good time to have to raise more capital? If the trial succeeds, management could switch over to the more desirable Cantor ATM from the drip, drip LPC ELOC.

In the absence of trial results, I suspect investors would be pleased to see an even larger cash position. I personally doubt the timing of the renewed LPC deal was a coincidence.

If the rule is “buy the rumor” wouldn’t it be a good idea for a company to raise capital by “selling into the rumor”?

I keep reading that statement. What specific part of the trial design would you point to that would make the trial “fail early”?

Or put another way, not paying the CRO resulted in a delay of what turned out to be bad news of a failed trial for that company. Makes me wonder if companies do have access to blinded results in real time. If no one is improving then there is no need to unblind to anticipate results.

Just a question I had based on what happened in that particular instance.

A sample timeline from another small pre-revenue biotech you are familiar with. Looks like it took 6 months from last visit to database lock?



December 21, 2017
Innovation Pharmaceuticals Completes Final Patient Visit in Phase 2b Study of Oral Prurisol for Psoriasis

“
BEVERLY, Mass., June 29, 2018 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces database lock for its Phase 2b clinical trial of oral Prurisol in moderate-to-severe chronic plaque psoriasis.”


http://www.ipharminc.com/press-release/2017/12/21/innovation-pharmaceuticals-completes-final-patient-visit-in-phase-2b-study-of-oral-prurisol-for-psoriasis



https://www.globenewswire.com/news-release/2018/06/29/1531836/0/en/Innovation-Pharmaceuticals-Announces-Database-Lock-for-Phase-2b-Trial-of-Oral-Prurisol-for-Psoriasis.html

In your opinion which specific section would apply to how long they are allowed to “dig deeper” into the secondary endpoints before revealing if they hit or missed the primary endpoints? I don’t see one that looks like it would cover it.


https://www.sec.gov/fast-answers/answersform8khtm.html

There are 12 months in the year. “Mid year” is the middle 6 months. April to September. Also best to remain ambiguous for LPC purposes.