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Thanks. Chase is a daytrading term, for when you commit, set a target and exit without a care for anything. If you consider the stock an investment opportunity, you do DD and commit based on that.
This stock is running up ahead of the catalysts. MC blew past $50M today. That is absurd. The chart says it has to drop. It may get more absurd, as the company has a real knack for playing the promotions.
There is no rule against taking huge profits and increasing your interest when the pps falls back. That is how you build ownership in a company that you believe is a real long-term winner.
GLTA
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Sell it now.
Committing that much capital and being up this far but asking for advice from a MB? Sell it. Leave 20K as markers. Sit back, breathe...regroup and do more dd. Do the same thing on 3 other stocks. Rinse, repeat. Good luck.
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Sure hope not. Leaving just enough to sell the opening pop, and if it doesn't top-out there, I'll suck wind on the best sustained spike I have seen.
Won't cry too hard, I took seven figures off the table today.
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boom...to the moon......baby! §
It is a matter of whether people get a chance to take the drug for a decade! That would indeed be disease modifying. "Cure" could only be based on patient longevity vs the average life span. The patients are at an average of 78% or-so of that figure to start.
What if it actually statistically prolongs life? Would that be a "cure"?
I'd be a "peach"...that's for sure.
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Happy 70,000th AVXL Board!!! Roll it to a milly peeps!!
GO ANAVEX!!!!!$$$
This board had 4 followers in March. Still only 63. Hidden gems do happen. Hitting 1400% on marker shares!
GLTA
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You're all very welcome. People are the strongest asset. Prof Hampel tweets AVXL..."nuff said".
Had a few days lately with zero news on over 130 stocks in the port. Today...98! Gonna be a busy day.
GLTA GO ANAVEX!!!!
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Surely be here:
http://worldeventsforum.com/addf/addrugdiscovery/
As part of the ACT/AD coalition:
http://worldeventsforum.com/addf/addrugdiscovery/supporters/
PsychoGenics did our RETT syndrome preclinical and will be exhibiting.
The MJFF-sponsored preclinical findings should be here:
http://www.wpc2016.org/
Catalysts could abound.
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Always a counter to the thinking that off-label prescribing will become rampant. Approval process, Orange Book entry, good prescribing practices, etc all protect the physician from, otherwise, very rampant libel suits. They don't just say, "Here, try this!".
7-year ODE in the rare indications could be crucial to wringing A2-73 for all it's worth. Diligent pursuit of the PCT protection and clinical development in epilepsy could add billions to the bottom line. Any reduction in gross seizure rate will be welcomed. I have witnessed, first hand, the effect of S-1 agonists on epileptics. A clinically administered dosing regimen of such potent modulators is imperative. Anavex has the correct methodology.
Every move that lends more credence to the idea of a blanket CNSD therapy raises the level of possibilities. Many other catalysts could be set to pile on in the event of something such as BTD.
Making doctors and patients more comfortable with alternative therapies is part of the Mixed S-M advantage, if there is a wide margin of safety. Attenuating cholinergic and NDMA side effects, allowing for more potent combo therapies, could be a supreme advantage to this new class of drugs.
If a next phase trial armed 30mg A2-73 + 20mg don vs 10mg don + placebo in mild AD patients over 28 weeks, I think the outcome difference would be staggering.
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Anavex Presents 31-Week Safety Data from Phase 2a Study of ANAVEX 2-73 in Alzheimer's Patients at AAIC 2016
Jul 24, 2016 09:30:00 (ET)
Results Feature Favorable Safety, Maximum Tolerated Dose, Positive Dose Response as well as Positive Unexpected Therapeutic Response Events
NEW YORK, NY – July 24, 2016 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced data from the first of two posters at the Alzheimer’s Association International Conference® (AAIC) 2016.
Data presented in the first poster highlights the evaluation of a maximum tolerated dose (MTD) of ANAVEX 2-73 as primary endpoint of the Phase 2a study in mild-to-moderate Alzheimer’s patients, as well as additional clinical safety data and positive unexpected therapeutic response events, such as improved mood, improved social engagement and increased independent activities through 31 weeks. The second poster will present efficacy data through 31 weeks.
“ANAVEX 2-73 data presented today is prerequisite information in order to progress into Phase 2/3 placebo controlled studies,” said Professor Harald Hampel, MD, PhD, Professor and AXA Research Fund Chair at Sorbonne Universities’ Pierre and Marie Curie University (UPMC), Paris, France and member of Anavex’s Scientific Advisory Board. “ANAVEX 2-73’s specific molecular biology, combined with its observed favorable safety and tolerability profile makes it a very interesting candidate to explore in further clinical trials of different neurological diseases.”
Dose-response analysis indicates a cognitive benefit associated with ANAVEX 2-73 (both MMSE and EEG/ERP improved significantly at 5 weeks of treatment). Low-High dose was statistically significant to affect MMSE-? and ERP-? scores with MMSE-? (p=0.0285) and ERP-? (p=0.0168), respectively.
ANAVEX 2-73 continues to demonstrate a favorable adverse event (AE) profile through 31 weeks in a patient population of elderly Alzheimer’s patients with varying degrees of physical fragility. The most common side effects across all AE categories tended to be of mild severity grade 1, and were resolved with dose reductions that were anticipated within the adaptive design of the study protocol. The poster presentation is available on the publications page of the Anavex website.
“We are encouraged by these new results, which provide us with valuable knowledge about ANAVEX 2-73 and allow us to proceed methodically in the development of ANAVEX 2-73,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.
About the ANAVEX 2-73 Phase 2a Study
The multi-center Phase 2a clinical trial of 32 mild-to-moderate Alzheimer’s patients consists of two parts. In PART A ANAVEX 2-73 is administered during five weeks in a randomized, open-label study with adaptive design. PART B is continued administration of ANAVEX 2-73 in a voluntary 52-week open-label extension, followed by an additional voluntary 104-week extension study, allowing for the gathering of safety data for ANAVEX 2-73 cumulatively over three years.
The primary endpoint of the Phase 2a trial is to establish safety, tolerability and maximum tolerated dose (MTD) of ANAVEX 2-73. Secondary endpoints includes exploratory cognitive as well as functional measures using Mini Mental State Examination (MMSE) and evaluation of Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL), respectively.
Additional information regarding the ongoing Phase 2a clinical study is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation (MJFF) for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Matthew Haines
River East Investor Relations, LLC
917-733-9297
mhaines@rivereastir.com
Media:
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com
FacebookTwitterGoogle+LinkedInShare
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Axovant highlights a carefully crafted comment by Dr Hampel:
""Results of our recently published brain imaging studies add to the growing amount of clinical and scientific evidence that supports the importance of the cholinergic system in the treatment of Alzheimer's disease. Hopefully, we will soon get additional innovative compounds and therapies that will further enhance the cholinergic brain system. Companies like Axovant and others are in the late-stage development process of such novel compounds. If they are successful with the development of these compounds, then we believe they could be used in combination with standard of care therapies that we have today. That's really good news for patients and caregivers," said Dr. Hampel, Professor at the Department of Neurology, Marie Curie University and AXA Research Fund Excellence Chair (Sorbonne Universities), and representative of the Hippocampus Study."
I don't find any direct relation between Dr Hampel and Axovant, however, he does sit on the SAB of Anavex. His comment appears to protect that association while under Axovant's hedgified spotlight. (chuckles)
Dr. Hampel had this to say about A2-73:
“The collective data from this Phase 2a trial supports the concept of targeting the sigma-1 receptor with ANAVEX 2-73 with a degree of confidence that we did not foresee. Sigma-1 receptor presents an innovative interventional upstream approach to impact key cellular events believed to contribute to Alzheimer’s disease pathophysiology. The presented Phase 2a data underlines the importance of rigorously investigating a potential efficacy signal on co-primary outcomes such as cognition and function in larger and well-powered trials”.
And most recently giving the nod to other indications:
“ANAVEX 2-73’s specific molecular biology, combined with its observed favorable safety and tolerability profile makes it a very interesting candidate to explore in further clinical trials of different neurological diseases.”
Little Orphan Annievex has her support.
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Please reference and link to the data we are to compare to.
Anavex 2-73 results methodically presented at AAIC 2016
SUNDAY
Primary endpoint:
Safety, tolerability and maximum tolerated dose (MTD) finding study.
WEDNESDAY
Exploratory secondary endpoints include: Pharmacokinetics, MMSE,
Cogstate, EEG/ERP, ADCS-ADL.
Sunday's poster reflects complete analysis of data to the 26 week mark for the PO. This is what we were looking for in March for 12 weeks but has been stretched-out to the 26 week point. That is a fantastic accomplishment by the company, in light of the thoroughness of the analysis.
Outstanding Team Anavex!!!
N=27 at 31 weeks. 4 SAEs with 3 resulting in withdrawal during the PART B consisting of:
- Delirium Grade 3: Not related
- Fractured ankle Grade 2: Not related
- Urinary tract infection Grade 2: Not related
- Hodgkin's lymphoma Grade 2: Unlikely related; Patient has developed
Hodgkin’s lymphoma. Patient’s comorbidities include Sjogren’s
syndrome, which increases the risk of lymphoma between five-and ninefold.1
Will stay on study while undergoing radiation therapy.
Look at the Safety Overview, particularly [Psychiatric disorders], and realize the correlation of these AEs to the 16 reported 'Therapeutic Response Unexpected' events outlined below it. These are the anecdotal reports reported in the Aussie pump that I mentioned could be reported as this type of AE. The adaptive design will allow for this category of events to be reported as a therapeutic response BENEFIT in-line with Quality Of Life outcome measures in the P2/3. Adaptive trial design at it's finest!
I believe this remark underlines A2-73's unprecedented safety profile:
It can be concluded that doses lower
than 50.58 mg could be tolerated by 5%
of the most frail patients, whereas,
doses higher than 70.28 mg could be
administered to 5% of the most robust
patients in the population.
The conclusions outline the PART A (5 week) results and set the stage for Wednesday's supporting data, which I bolded.
• The traditional definition of MTD was updated in the presence of
inter-patient variability. For AD patients 50.58 mg of ANAVEX 2-73 is
the maximum tolerated dose taking into account most frail patients
(5% of total patients). In half of these patients a DLT event will occur.
• In PART A, MMSE-?-, ERP-?-scores vs. ANAVEX 2-73 doses
displayed a significant positive slope for the ANAVEX 2-73 dose with
confidence intervals that excluded the zero-value.
• The MTD determination from the present Phase 2a study, allows for
a Phase 2/3 study to be conducted according to a double-blind
design including placebo. To complete the design of a future study,
population PK data (and the evaluation of inter-patient variability) are
necessary in order to compute the patients’ sample size and to
achieve conclusions associated with a given statistical power. This is
currently in progress.
• ANAVEX 2-73 may have a broader scope in addressing diseases by
virtue of both its molecular biology and the favorable safety profile
observed thus far. Estimating MTD is a prerequisite for the
progression of ANAVEX 2-73 towards further clinical trials.
They waited until 26 weeks, "so that there can be no doubt as to the cause-effect relationship of the 12-week efficacy data".
This concludes the clinical safety and dose-finding part of the mission. Wednesday we will get the matching 26-week PK/PD safety and efficacy results. We will then be armed with the necessary data to draft a protocol for FDA submission on a pivotal P2/3.
Dr Hampel makes it clear, “ANAVEX 2-73 data presented today is prerequisite information in order to progress into Phase 2/3 placebo controlled studies”
Got my bowl of popcorn ready
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Nice K-O! Silly characters...unreal. §
Ms Boenstitch, who seemed to be filling in...in a friend sort of capacity, from Uncle Tom's Canadian ties...got drawn into the litigation. She is free now, and Missling is back to wearing 3 hats.
The EA seems to go from a 'best of worst-case scenarios, ala secondary/LPC financing, to ducks in-a-row, ready to take it to next level arrangement.
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Yes, but the EA from 07/05 states:
"3. SECTION 2. The Parties agree that Section 2 of the Employment Agreement shall be amended by deleting the words “and “Chief Financial Officer” ”, and the following paragraph shall be deleted from Section 2 of the Employment Agreement:
“Notwithstanding the foregoing, you shall be permitted to serve (i) as an employee, consultant, officer and/or director of, and provide services to, Brimberg and R.F. Lafferty, and (ii) on the board of directors of any other company or entity, except for companies that do compete directly with the Company’s principal line of business within the United States.”"
powerwalker: Sorry for being vulgar. Is it the 844 number you called? I only email, and am UTI that Christine Payne/Primoris is no longer affiliated. If the 844 number goes to her, that adds a layer of mystery to things. Please elaborate, is what I should have said...
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Matthew Haines
River East Investor Relations, LLC
917-733-9297
mhaines@rivereastir.com
Media:
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com
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Hun? Christine Payne, of Primoris? The IR firm that has been disassociated with Anavex since last year?
Is that not what this says?
"2. Titles and Authority
(a) Officer Positions and Reporting Lines. During the Employment Term, you shall have the title of “President and Chief Executive Officer” and “Chief Financial Officer” of Employer and shall have the powers, responsibilities and authorities customary for the chief executive officer of corporations of the size, type and nature of Employer. During the Employment Term, you will report solely and directly to the board of directors of Employer (the “Board”). You hereby accept such employment and agree to devote substantial business and professional time and energy to the business and affairs of the Company."
https://www.sec.gov/Archives/edgar/data/1314052/000161577416006259/s103666_ex10-1.htm
Down in the exhibits...I missed it at first, not going passed the sigs.
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LAFF served as placement agent for the original $10M LPC financing to get the P2a started, which Missling brought with him in 2013. I assumed he has ties with them that became the subject of COI concerns when starting, so his association was indemnified. The original EA had this removed, now it is back in the new EA.
So again, it seems under the old EA he was to sever ties with Brimberg/LAFF, indicating dedication to AVXL business, but now he is free to operate unrestrained. A corporate structure change would jive with that.
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Very good analysis Honeycomb777. The BH acquisition has been buried under the ANDA hype, and coupled with strong current product sales (my local Walmart connections show substantial monthly case order increases) means great revenues going into "Flutie Care"
The dilution shares were evident in the premarket trades seen last month, and likely WC needs for share-only vendors, promotional services, and the office. No problem.
I hold 2.76% of this issue. Dr Damaj is plenty spiffy!
GLTA
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Well that would be more sweller!
If Missling EVER threw a hint, this is it. I can't find a reason to see this as bad.
"Son of a bitch, give me a drink!"...and some Hugo, CO water, PLEASE!
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Oh shit! I just saw that myself! He was removed as CFO in the original EA, due to Ms Boenstitch's position. Now, he's back to being CEO/CFO (He trumps her by a mile as CFO, ie: Negotiator!)
"2. Titles and Authority.
(a) Officer Positions and Reporting Lines. During the Employment Term, you shall have the title of “President and Chief Executive Officer” and “Chief Financial Officer” of Employer and shall have the powers, responsibilities and authorities customary for the chief executive officer of corporations of the size, type and nature of Employer. During the Employment Term, you will report solely and directly to the board of directors of Employer (the “Board”). You hereby accept such employment and agree to devote substantial business and professional time and energy to the business and affairs of the Company.
Notwithstanding the foregoing, you shall be permitted to serve (i) as an employee, consultant, officer and/or director of, and provide services to, Brimberg and R.F. Lafferty, and (ii) on the board of directors of any other company or entity, except for companies that do compete directly with the Company’s principal line of business within the United States."
Original EA:
"3. SECTION 2. The Parties agree that Section 2 of the Employment Agreement shall be amended by deleting the words “and “Chief Financial Officer” ”, and the following paragraph shall be deleted from Section 2 of the Employment Agreement:
“Notwithstanding the foregoing, you shall be permitted to serve (i) as an employee, consultant, officer and/or director of, and provide services to, Brimberg and R.F. Lafferty, and (ii) on the board of directors of any other company or entity, except for companies that do compete directly with the Company’s principal line of business within the United States.”
Oh yeah...we been sold!
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Yes, like perhaps a big enough offer is on the table that they decided to sell it all. The original agreement was likely drafted some time ago, and appeared straightforward. Then this new agreement appeared, apparently not able to supersede the first grant from the old agreement, thus the $2M worth.
Why would an EA that was expected and did appear, and seem to be the product of a firm plan, suddenly change? The first plan appeared to me to benefit the executive if the SS was diluted going into the final 5/9 vesting in 07/19. That $3.33M vesting then on heavy dilution would be a whole lotta shares. Then when the approval catalyst puts the MC to match the SS, he cleans-up.
Now he is more set to take advantage of a buyout and the vesting schedule matches that which is more normal, and perhaps more suitable to the framework of a buyout.
That's how it looks to me. Tell me how I'm so sadly mistaken...somebody...please!
$5B would be $140/sh. The pipeline could be worth that, no?
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Something happened after July 5th? Instead of cash-based options granting in subsequent years, he is getting an additional $6M straight options with all being granted immediately.
Then the stickler..."Upon a Change in Control, all previously granted but unvested stock options shall vest." In the previous filing this meant he would lose the options not yet granted.
Smells like an offer that can't be refused, perhaps.
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Haha! You're a good sport. Looking forward to your post. §
Where do I buy tickets? Can I bring my Flutie Flakes? §
Yes! They have Federal Marshals standing by with orders to...
The company will PR the data. Sunday morning, I suppose...if that's how it has to be.
I'm going to try and wait until late Sun night to look.
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You left this to go down 43% on two-days-late into an SGBY pump?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124024143
Woo-hoo! 15ers...
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OPTION CHAIN AVXL - OCT, 21 '16
Open Interest Tot. Volume $ Chg. Close Last Trade Bid Ask Strike Price
807 0 0 4.8 4.4 5.5 2.5 0 0.85 0.05 0 0 1146
1577 0 0 2.25 1.85 3.3 5 0.55 1 0.75 0 0 332
1931 0 0 1.35 1.2 2.1 7.5 1.9 2.3 2.35 0 0 176
710 0 0 0.7 0.5 1 10 3.6 4.5 4.28 0 0 203
336 100 0.03 0.45 0.25 0.75 12.5 5.6 7 6.59 0 0 165
29 0 0 0.35 0.1 0.6 15 6.8 10.2 0 n/a 0 0
The paint-drying trading is excruciating, though!
MacA & F? I got some VTVT markers too! See what that does next week.
GL! (ILNS BABY! )
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That's better... §
When you gonna buy some more .42s?
Clearer? No, this is murky as can be. They changed the agreement yesterday and granted Missling another $6M+ in options? Now he has at least $8M, all granted, and vesting quarterly over 3 years?
We'll see what the 8K says...I'll hold my tongue.
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What's up Papa? Not buying anymore? Must mean the tender offer is being drafted. Going to release that stellar Q, let it run up and sell that excess during the window? Smart move!
Can't wait to join the fun!
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All part of that employee ownership incentive plan from a while back. I started a position then, but then the plant flooded. Once production starts again this should head up. 42¢ book value, I believe.
I finished adding under .115 so ready for go-time!
GLTA
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Seems to disagree with the contract:
"5. SECTION 4. The Parties agree that Section 4 of the Employment Agreement shall be amended and restated as follows:
4. Stock Options. In addition to your Base Salary and Bonus, you shall receive the following stock option grants:
(i) On July 5, 2016, you shall receive Two Million Dollars ($2,000,000) of options for shares of the Company’s Common Stock, one-third of which shall vest on July 5, 2017, one-third of which shall vest on July 5, 2018, and the remaining one-third shall vest on July 5, 2019;
(ii) On July 5, 2017, you shall receive Two Million Dollars ($2,000,000) of options for shares of the Company’s Common Stock, one-half of which shall vest on each of July 5, 2018 and the remaining one-half shall vest on July 5, 2019; and
(iii) On July 5, 2018, you shall receive Two Million Dollars ($2,000,000) of options for shares of Anavex Common Stock, all of which shall vest on July 5, 2019."
https://www.sec.gov/Archives/edgar/data/1314052/000161577416006259/s103666_ex10-1.htm
I dunno? Maybe not try and figure it out...just keep trying to accumulate ahead of him!
Cheers!
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ed- And notice i & ii say "the Company’s"...iii say's "Anavex". Nobody's perfect, especially when wearing so many hats. Prolly see another 8K to correct it all.
Not at all.