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They weren't able to deliver remarkable news after up listing. AVXL will deliver on 11/7.
I share your enthusiasm regarding the quick up list to Nasdaq. The much smaller O/S and eligibility for tute buying is awesome.
Due to the reverse split, AVXL will be forward splitting much sooner in the future.
NVIV announced reverse split before trading on 4/8 -
On 4/7 the closing price was $11.60
On 4/8 the opening price was $12.00 - No sell off at the open.
The day high was $12.60 and the close was $12.15 - No sell off during the day.
NVIV announced their reverse split for up listing on 4/8. They started trading on the Nasdaq on 4/17.
CAMBRIDGE, Mass. (April 16, 2015) – InVivo Therapeutics Holdings Corp. (NVIV) today announced that its common stock has been approved to begin trading on The Nasdaq Capital Market. The company’s common stock will begin trading under the symbol “NVIV” at the opening of trading on Friday, April 17, 2015. “We are pleased to reach this important corporate milestone. InVivo has made significant progress spanning all areas of the organization over the last year and uplisting to Nasdaq will allow us to communicate this progress with a broader audience.
The correction has been made -
The reverse stock split will reduce the authorized shares of common stock from 400,000,000 prior to the split to 100,000,000 after the reverse stock split.
This reverse split and planned up listing may ignite a rally. NVIV had a big pop after they announced a 1-for-4 reverse split on 4/8.
Split adjusted, the stock closed 4/7 at 11.60 and climbed as high as 19.40 on 4/17 before pulling back. The 11/7 conference catalyst may enable AVXL to hold on to a possible share price pop.
InVivo Therapeutics announces implementation of reverse stock split in preparation for planned uplisting to NASDAQ
8:02 AM ET 4/8/15 | Briefing.com
Co announced the implementation of its previously disclosed 1-for-4 reverse stock split as of today, April 8, 2015, a key step in preparation for its planned uplisting to the NASDAQ Capital Market.The company's common stock will begin trading on a post-split basis at market open today, April 8, 2015, under the symbol "NVIVD," with the "D" added for 20 trading days to signify that the reverse stock split has occurred.
Best to concentrate on Avxl's trials, not other drug trials. From CEO, Christopher Missling himself -
That is a very misleading post. What's your agenda?
No, he's a legend in his own mind. Shouldn't be long before he wakes up one day and realizes that TA is not reliable and never has been.
That's the day he will join the 90% of busted traders.
The successful traders have a grip on fundamentals and lack arrogance. Being clearly clueless is a path to losing the last $.
Good to hear se88!
As you know, the 7/22 trial data as remarkable - http://www.anavex.com/?news=anavex-presents-positive-initial-phase-2a-study-data-with-anavex-2-73-showing-early-evidence-of-improving-cognition-in-patients-with-alzheimers-disease-at-aaic-2015
A lot of additional data, and additional patient and care giver responses, have been collected since then for both Part A and Part B. With this additional data in hand, Dr. Missling made what I consider to be 2 very important statements while presenting on 9/23 -
What is also important to appreciate, effect was shown in 12 patients, and 10 of 12 had an improvement of the signal. So, relatively robust. Not a skewed statistical effect.
(ME - We can expect the robust results to continue!)
Physicians have told us that the safety profile is stronger than donepezil, the bestselling drug on the market.
(Me - Safety is of little concern going forward!)
http://wsw.com/webcast/ladenburg/avxl/index.aspx
Only time can tell us the duration of A2-73 and A2-73 plus's effectiveness. This is the big unknown for me. From page 9 of the fall presentation -
FDA has approved 4 drugs for AD that only temporarily slow worsening of symptoms for 6-12 months in ~50% of patients
My hope is that Anavex's compounds prove efficacious for many years due to their MOA that targets the root causes of Alzheimer's Disease as opposed to the 4 approved drugs that only target symptoms of AD.
http://www.anavex.com/files/Anavex_Presentation_Fall_2015.pdf
For me, AVXL's rise to prominence is a matter of when, not if!!!
Yes, Anavex renewed the 2013 purchase agreement with Lincoln Park on 7/8/15. The agreement states that Lincoln Park cannot be required to buy shares if the share price falls below 50 cents. It did in 2013 and stayed there until July 2015.
My post on July 9th, 2015 -
Yesterday's filing tells us that Anavex may sell up to 9,500,000 shares to Lincoln Park. Should there be a nice price spike as the result of news on July 22nd, AVXL is now in a position to require Lincoln Park to buy shares. Great planning by Missling, IMO.
From filing - http://ih.advfn.com/p.php?pid=nmona&article=67627501&symbol=AVXL
As of May 14, 2015, there were 77,243,580 shares of our common stock outstanding, of which 48,215,168 shares were held by non-affiliates, excluding the 591,858 shares that we have already been issued to Lincoln Park under the Purchase Agreement. Although the Purchase Agreement provides that we may sell up to $10,000,000 of our common stock to Lincoln Park, only 9,975,267 shares of our common stock are being offered under this prospectus, which represents (i) 250,000 shares that we issued to Lincoln Park in the Initial Purchase, (ii) 341,858 shares that we issued to Lincoln Park as a commitment fee, (iii) an additional 9,250,000 shares which may be issued to Lincoln Park in the future under the Purchase Agreement, and (iv) 133,409 shares that we are required to issue proportionally in the future, as an additional commitment fee, if and when we sell shares to Lincoln Park under the Purchase Agreement. The additional commitment shares are issued pro rata as Lincoln Park purchases up to $10,000,000 of our common stock as directed by us.
For example, if we elect, at our sole discretion, to require Lincoln Park to purchase $100,000 of our stock then we would issue 1,334 shares of the pro rata commitment fee which is the product of $100,000 (the amount we have elected to sell) divided by $10,000,000 (the total amount we can sell Lincoln Park under the Purchase Agreement multiplied by 133,409 (the total number of pro rata commitment shares). The pro rata commitment shares will only be issued pursuant to this formula as and when we elect at our discretion to sell stock to Lincoln Park. Lincoln Park may not assign or transfer its rights and obligations under the Purchase Agreement.
If all of the 9,975,267 shares offered by Lincoln Park under this prospectus were issued and outstanding as of the date hereof, such shares would represent approximately 13% of the total number of shares of our common stock outstanding and 20% of the total number of outstanding shares held by non-affiliates, in each case as of the date hereof.
If we elect to issue and sell more than the 9,975,267 shares offered under this prospectus to Lincoln Park, which we have the right, but not the obligation, to do, we must first register for resale under the Securities Act any such additional shares, which could cause additional substantial dilution to our stockholders. The number of shares ultimately offered for resale by Lincoln Park is dependent upon the number of shares we sell to Lincoln Park under the Purchase Agreement.
Awesome list stealthways and sokol -
From this weeks audio presentation -
12 - What is also important to appreciate, effect was shown in 12 patients and 10 of 12 had an improvement of the signal. So, relatively robust. Not a skewed statistical effect.
13 - Physicians have told us that the safety profile is stronger than donepezil, the bestselling drug on the market.
DD - Updated Collection Of Recent Articles With The Most Recent Articles First:
https://msevents.microsoft.com/cui/m/EventDetail.aspx?EventID=1032673848&Culture=en-US&community=0
Sphere3D Brings Industry’s First Windows Containerization Platform and Enterprise NAS to Microsoft Azure
$ANY @Sphere3D notes Investor Meeting NYC & dinner afterwards, NASDAQ Ringing, $MSFT Technology Center, AGM. What a week it was! http://howtofindbigstocks.com/wp-content/uploads/2015/06/SpiffySummaryWeekofJune152015.pdf …
http://t.co/CXZ0UrHett
Must Read - Most in-depth DD on Sphere3D
http://searchvirtualstorage.techtarget.com/news/4500246315/Sphere-3D-CEO-Virtualization-containers-will-be-face-of-our-company
Are you suggesting that Sphere 3D could eventually replace hypervisors? That's a pretty lofty claim.
Kelly: I wouldn't say we will eliminate them completely. I started my career on the mainframe side, and mainframes still exist, but they aren't the dominant players. I think virtualized storage is heading in the same direction in that things are getting pushed closer to end users. It's still early, but we haven't found applications that we can't virtualize. The toughest one was to see if we could virtualize a mainframe. We're pushing the limits. People talk about the 30% of apps that just won't virtualize. We actually virtualized a DEC PDP-8, which was the oldest version we could find. We used our container technology to split the DEC operating system into a container and are serving it up on our storage device.
http://sphere3d.com/sphere-3d-and-novarad-enter-into-master-purchase-agreement-to-deliver-virtualization-capabilities-to-400-healthcare-facilities/
Sphere 3D and Novarad Enter Into Master Purchase Agreement to Deliver Virtualization Capabilities to 400 Healthcare Facilities
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=113637113
An excellent explanation of what the Sphere 3D/Novarad Master Purchase agreement entails by an industry insider.
http://money.cnn.com/news/newsfeeds/articles/globenewswire/10130532.htm
Sphere 3D and Microsoft to Showcase Virtualization and Cloud Solutions
Joint Roadshow Will be Held at Microsoft Technology Centers and Include Demonstrations of Sphere 3D's Technologies for the "Next Cloud"
http://rcpmag.com/articles/2015/04/01/containers.aspx
Docker isn't the only container solution Microsoft is embracing. Sphere 3D last month said its Glassware 2.0 Microvisor can virtualize infrastructure components and the application stacks from both Windows and non-Windows-based systems and claims it can "outperform" any existing hypervisor-based infrastructure. Furthermore, Sphere 3D said it can be used for systems and cloud management, orchestration and clustering.
It's still early days for containers in the world of cloud computing, but if they live up to their promise, they can raise the bar for performance and portability.
http://virtualizationreview.com/articles/2015/03/10/windows-containers-and-microvisors.aspx?m=2
Windows Containers and 'Microvisors'
A new Microsoft partner, Sphere 3D, is making containers that have fewer dependencies than Docker.
http://channel9.msdn.com/Blogs/AzurePartner/Sphere-3D-Microsoft-Bring-Windows-App-Containers-to-Azure
Sphere 3D, Microsoft Bring Windows App Containers to Azure
Sphere 3D Corporation, whose Glassware 2.0 Windows container technology for application delivery simplifies IT infrastructure, has collaborated with Microsoft to support Glassware 2.0 on Microsoft Azure. The move means organizations now have the tools to make cloud migration of Windows-based, end-user computing applications from physical infrastructure to Azure even easier and faster.
"We are committed to providing our customers with new and innovative ways to implement their cloud strategy," said Vibhor Kapoor, Director of Microsoft Azure Product Marketing. "By working closely with Sphere 3D, we are able to continue to deliver on that commitment and provide a new level of flexibility for organizations looking for scalable application delivery from the cloud."
Read Sphere 3D Corporation's press release to learn more about how Glassware 2.0 on Azure is part of a well-rounded migration strategy.
http://sphere3d.com/sphere-3d-and-microsoft-to-deliver-glassware-2-0-windows-application-containers-on-microsoft-azure/
Recent twitter exchange -
Zig Jones ?@zigzagjones1
@lauradidio Hey Laura, just wondering if you ever got to do a deep dive review of Sphere3d tech? Thanks
Laura DiDio ?@lauradidio
@zigzagjones1 Yes, I did & it does everything it claims to do. Sphere3D Glassware 2.0 & V3 Appliances are all excellent.
http://itic-corp.com/analysts/
Laura DiDio, Principal, is a highly visible information technology industry analyst, consultant, a professional writer and a former reporter. DiDio has 20 years experience in the high technology industry. She has consulted with all of the major industry vendors including: Apple, Accenture, Avaya, Citrix, Dell, HP, IBM, Microsoft, Novell, Oracle, SAP and VMware.
http://m.seekingalpha.com/article/2966296-cloud-computing-wars-2015-google-microsoft-docker-sphere-3d-and-vmware?source=twitter_salphatech
http://seekingalpha.com/article/2930376-sphere-3d-has-a-large-upside?page=2&auth_param=uckhf:1aeebr6:709a9965faa16abd2c5a72ed534ca53b&dr=1
http://www.arnnet.com.au/article/565477/tape-storage-industry-bounces-back-strongly-tsc/
Very good news for Sphere 3D's recently acquired OVRL/Tandberg storage -
Demand for tape is being fuelled by unrelenting data growth, significant technological advancements, tape's highly favorable economics, the growing requirements to maintain access to data 'forever' emanating from regulatory, compliance or governance requirements, and the big data demand for large amounts of data to be analyzed and monetized in the future. The Digital Universe study suggests that the world's information is doubling every two years and much of this data is most cost-effectively stored on tape.
Press Release -
http://finance.yahoo.com/news/sphere-3d-glassware-delivers-solutions-130200572.html
Presentation mentioned in press release -
https://docs.google.com/presentation/d/13q1vG-OOKTVHH0Xj-VWgPVXkq8vNNTVnHHzzigvj72s/mobilepresent?pli=1&slide=id.g4f09ef1d6_00
https://twitter.com/Sphere3D
Recent collection of tweets. Pay particular attention to the pictures showing Sphere 3D's Glassware 2.0 having been newly added to Dell's servers!
http://dortchonit.quora.com/Sphere-3D-Virtualization-+-Cloud-Apps-Anywhere
This isn't just theory or "demoware," either. Earlier this year, for example, Google announced that Virginia's Chesterfield County Public Schools (CCPS), one of the largest school systems in the US, was buying 32,000 Dell Chromebooks, one for each of its middle and high school students. And the school system has decided to implement Sphere 3D technologies to deliver Windows applications to those Chromebook users. (My learned industry colleague Simon Bramfitt has written a great summary and analysis of how CCPS made its decisions and how Sphere 3D differs from other desktop virtualization approaches: "Chesterfield County Schools Turn to Sphere 3D for Windows on Chromebooks.")
http://www.virtualizationpractice.com/sphere-3d-launches-glassware-2-0-appliance-windows-apps-28468/
Sphere 3D Launches Glassware 2.0 — An Appliance for Windows Apps Simon Bramfitt August 28, 2014
Aside from its being a hardware appliance, it is its inherent simplicity that is Glassware’s first key differentiator. Provided you know how to plug in a network cable and assign an IP address, you can install a Glassware appliance. If you know how to install a Windows app, then installing and publishing an application on Glassware shouldn’t present any problems. In short, with Glassware, anyone can manage their own enterprise-class application hosting environment.
http://seekingalpha.com/article/2387975-panic-selling-turns-into-panic-buying-in-sphere-3d?uprof=45&dr=1
•Glassware is able to virtualize more applications (many critical applications are very hard to virtualize), it works where other systems provide no solution (for instance, old legacy software running on mainframes)
•The simplicity of the virtualization of applications, any Windows app can be virtualized with six clicks
•It's considerably more resource efficient, opening up the market for small and medium enterprise
http://www.gztandberg.cn/en/
The China manufacturing plant Sphere 3D acquires in the Overland merger.
http://en.community.dell.com/dell-blogs/direct2dell/b/direct2dell/archive/2014/08/04/drive-lets-customers-test-emr-without-disrupting-clinical-environment.aspx
The center also houses the support team for the DRIVE solution. DRIVE stands for Dell, Red Hat, Intel, VMware and Epic, the alliance of tech companies that began the collaboration to bring an open-source, Linux-based version of Epic to market that was affordable for smaller hospitals and clinics. Dell strengthened the alliance with the addition of Sphere3D, Agfa, Symantec and Hyland OnBase, creating the DRIVE Plus solution.
http://seekingalpha.com/article/2326065-citrix-killer-sphere-3ds-debut-on-nasdaq-merger-with-overland-purchase-of-v3-systems
The reason why I think Sphere 3D is a serious contender is as a result of several acquisitions the company has made in the last year, combining Sphere's Glassware 2.0 virtualization platform - by all accounts, a revolutionary approach to virtualization - with V3 Systems' Virtual Desktop products and Overland Storage's global data management and storage business.
The target is the $100 billion Virtualization/Storage space, and early indications suggest that Sphere 3D's Glassware 2.0 is already displacing the incumbents in enterprise-scale applications.
http://www.midasletter.com/midas-letter-financial-radio-podcast/sphere-3d-corp-vs-vmware-citrix-systems-microsoft/
Damian Wojcichowsky: I don’t think we’re talking about the same market per se at first. VMware and Sphere 3D right now are actually partners. So where VMware has a customer that requires the kind of functionality that Glassware 2.0 brings via Sphere 3D, they can partner there, so they can embed Glassware into the sale, and kick back a royalty or a license fee to Sphere 3D. I don’t see them competing for the same kind of customers. I think what you see is a lot smaller size of enterprise that you get Overland-Sphere approaching, versus the big enterprise deal that you see EMC-VMware do. So at first its not going to be that difficult. I think five years down the road you’re looking at more of a head-to head competition situation happening.
Shorter term though, you’re going to have a bunch of catalysts coming.
http://www.techzone360.com/topics/techzone/articles/2014/07/02/382802-want-slice-sphere3d-look-the-nasdaq-global-market.htm
Sphere3D has two key product offerings behind it: GLASSWARE 2.0 and the V3 Desktop Cloud Computing System. With GLASSWARE 2.0, users get access to the complete lineup of digital content found on most any desktop from most any Web-enabled device. This may not sound like much until the fullest implications of the idea are considered, as GLASSWARE 2.0 allows access to not only the full range of productivity software systems, but also to things like computer aided design (CAD) systems, proprietary systems, and even social media sites. Plus, at last report, all of the sites will both look and function the same way on mobile devices that said sites would on the desktop thanks to GLASSWARE 2.0.
http://www.virtualizationpractice.com/chesterfield-county-schools-turn-sphere-3d-windows-chromebooks-27278/
Chesterfield County Schools Turn to Sphere 3D for Windows on Chromebooks.
Taking on the complexity of managing a large Citrix XenApp environment was not something that CCPS wanted to have to address. At the same time, it wanted to ensure that any hosted Windows applications could be easily integrated into its own application portal. To overcome the challenges, CCPS has partnered with Mississauga, Ontario–based Sphere 3D, developers of Glassware 2.0, to provide Windows application hosting services. Sphere 3D provides Glassware 2.0 as an appliance-based hosting platform for installation either within a customer’s data center or as a cloud hosting solution offered by service providers. Sphere 3D company V3 Systems was one of the pioneers of high-performance VDI appliances, so it is to be expected that it knows how to make this approach work.
http://www.midasletter.com/2014/06/sphere-3d-overland-storage-merger-sets-emc-corporation-vmware-repetition/
There is little doubt that much of the velocity in Sphere 3D’s share price is driven by technology speculators who perceive the opportunity inherent in the timing of companies, managment and products converging within the Sphere 3D universe. My bet is that the combination of these elements under Sphere 3D’s managment will result in an exponential compounding of shareholder value quarter-on-quarter once the intergrations are complete and Overland Storage’s sales force is unleashed on its client base with the new offerings.
http://www.midasletter.com/midas-letter-financial-radio-podcast/sphere-3d-corp-tsx-vany-peter-tassiopoulos-podcast/
Peter Tassiopoulos: Absolutely. The transaction quickly transitions Sphere into a global enterprise. We will actually have operations in the U.S., Norway, Germany, Singapore, and Asia. In addition, we’ll have direct access to 17,000 resellers in 60 countries, and infrastructure that’s been built over thirty years to support them. As for the synergies, there’s quite a few.. it’s actually too numerous to go through all of them. But just a couple of highlights; you know Overland has providing storage for over thirty years as I mentioned, and because of this they’ve got a really large installed base. Actually over a million units have been deployed. Many of these are customers that run complex enterprise apps, and that’s specifically what Glassware is designed for. Now one of the largest purchasers of IT as well is the U.S. government, and Overland has a number of GSA’s [Government Service Agencies –ed] in place with them so that’s direct access into the government which we otherwise wouldn’t have.
http://www.brianmadden.com/blogs/bglive/archive/2014/06/10/brianmadden-com-podcast-with-sphere3d-at-9-30pst-today-what-do-they-do-join-us-live.aspx
BrianMadden.com Podcast #57 (Special Edition): Sphere3D talks about their microvisor-like app virtualization solution.
"We have more demand than we can handle" …."We're winning these deals"…"chaos of success"…"we are having demand on all sides for all products"….quotes from Peter Bookman
http://www.forbes.com/sites/cherylsnappconner/2014/05/16/cloud-and-virtualization-a-magic-combination-for-entrepreneurs/?utm_source=followingimmediate&utm_medium=email&utm_campaign=20140516
“The future of cloud is in taking the concept of virtualization beyond the backing up of data or the incorporation of additional systems,” says Peter Bookman, founder of virtualization company V3, recently acquired by Sphere3D. (Disclosure: Peter Bookman is a friend and was a client in 2010 and 2011; however we have no current business relationship.) “In our product lines we bring virtual desktops, virtual applications, and data together in a single solution to let companies of any size use virtual resources to manage their physical desktops, rich applications, and business information.”
http://www.auntminnie.com/index.aspx?sec=sup_n&sub=pac&pag=dis&ItemID=107377
Utilizing virtual application and desktop technology from Sphere 3D, NovaGlass delivers Novarad's Marz vendor-neutral archive software on a variety of computing devices, including PCs, Macs, iPads, laptop computers, Android tablets, and Google Chromebooks.
The new platform will give users access to several new features and ways of deploying images that were previously unavailable, Novarad said.
http://www.virtualizationpractice.com/happy-birthday-citrix-now-get-back-work-26248/
One possible opportunity here lies with Toronto-based Sphere 3D and Glassware. I had the opportunity for a brief look at Glassware last week, and I hope to be able to return for a more detailed assessment in the near future. In many respects, Glassware is to XenApp as VDI in a Box is to XenDesktop: a fresh approach to virtual applications, built from the ground up with an emphasis on the hypervisor as a means of achieving virtualization, rather than as a platform on which to run multiple operating system instances.
Glassware’s promise is not just that it is a legacy-free interpretation of conventional terminal services technology, but that it can take this approach to deliver more than just Windows applications. Demonstrating seamless delivery of Windows x86 applications alongside Android and Fortran apps on iPad is going to take more than one brief introduction to come to grips with. Nevertheless, if execution is as effective as the promise, this could be a technology to keep a close eye on.
http://seekingalpha.com/article/2142003-sphere-3d-a-disruptive-cloud-technology-player
Sphere 3D Corporation (TSX: ANY.V) (OTCQX: OTCQX:SPIHF) is a unique virtualization technology solution provider that has described itself as a company that "solves the problems that previously were considered unsolvable". What problems are there in virtualization? Plenty! Sphere 3D allows most devices, independent of their size, resources or operating system, to access the full functionality of software programs and applications off from servers either in the cloud or on premise, absolutely independent of their operating system! A short video on Youtube presents Sphere 3d's solutions in a graphical way.
In fact, its Glassware 2.0(TM) technology makes it possible for today's devices to access yesterday's software; for today's software to run on tomorrow's devices all over the cloud, without sacrificing performance or security. The company has built their proprietary Glassware 2.0 platform from the ground up and specifically designed it to achieve application virtualization in the most demanding of circumstances. It can be deployed alone for application virtualization or utilized in conjunction with third party hypervisor-based virtualization deployments, for true end-to-end virtualization of physical infrastructure. For additional information visit sphere3d.com and have a look to the presentation made by Peter Tassiopoulos during the CANTECH Investment Conference held in Toronto last January.
Although late to sign up, AVXL was accepted to present at the AAIC in July too.
Looks like remarkable data trumps deadlines.
For those that are unaware of this near term catalyst -
http://www.ctad-alzheimer.com/sites/ctad.prod/files/files/FinalprogramCTADsept29.pdf
Page 18. Notice the poster is late-breaking, again.
New Exploratory Alzheimer’s Drug ANAVEX 2-73: Clinical Cognitive Improvement observed in Mini Mental State Examination (MMSE) and other Cognitive Markers in a Phase 2a Study in mild-to-moderate Alzheimer’s Patients
Originally posted by WW
A couple more positive statements from Dr. Missling -
13:35 -
What is also important to appreciate, effect was shown in 12 patients and 10 of 12 had an improvement of the signal. So, relatively robust. Not a skewed statistical effect.
Physicians have told us that the safety profile is stronger than donepezil, the bestselling drug on the market.
WOW, you are really out of the loop -
The pump and dump team bought late March and sold late April. They didn't anticipate the remarkable data release that came on 7/22.
See the bottom sticky.
Not too late to make a bundle on this one by the end of the year.
Read all of AVXL's press releases for the last 2 years.
Edit - What's posted on the board is irrelevant!!!
I am surprised that the number of patients in the Phase 3 trial could be as low as 100 to 300. Judging from what the FDA states about adaptive trial design, it appears that they favor it over the statistical standard trial (placebo).
CM: We want to get a signal and the adaptive clinical trial allows us to increase the dose or decrease the dose until we see a signal. The mathematical model that Tasos speaks of sufficiently allows us to measure the data from these 32 patients because we are measuring many data points in this trial, from blood samples and the various cognitive tests, which allows for sufficiently precise data to learn how the drug works in order to select the number of patients needed for a Phase 3 pivotal trial. The number could range anywhere from 100 to 300 and the goal is to figure that number out.
The key is to understand the difference between a statistical standard trial, which is based on the placebo versus active dose in a number of patients, and the adaptive trial design statistical method used. The FDA has written a very eloquent guideline which you can find on the fda.gov website (http://www.fda.gov/downloads/Drugs/Guidances/ucm201790.pdf). The FDA states that with the adaptive trial design, which we are using, you need fewer patients, you are able to do this in a shorter period of time, you are more likely to demonstrate the effect of the drug, and you are getting more information on the treatment effect as well as a better understanding of dose response information in subgroups. Lastly, you are able to identify and optimize the parameters needed for Phase 3 effects. So, this Phase 2a trial is a very important stepping stone and building block for a successful Phase 3 trial. We want to avoid the same failure that the other Alzheimer drug trials experienced, and by implementing a different, innovative trial design for ANAVEX-73 in Alzheimer’s treatment, we are leading a more efficient study than a conventional study.
Yes, great insight into the reasons Anavex is using an adaptive trial design.
Info on TZ from Anavex.com -
Tasos Zografidis, MS, PhD
Dr. Zografidis, the Vice President Clinical Operations of Anavex, has over 25 years of experience in the pharmaceutical and healthcare industry, including 12 years at Wyeth (now Pfizer) in clinical project management and prior to joining Anavex most recently served as clinical and pharmaceutical consultant. He has been involved in more than a dozen clinical trials and has co-authored numerous publications. At Wyeth, Dr. Zografidis spearheaded population pharmacokinetics analysis and its implementation in the clinical setting and positively differentiated compounds. His work resulted in increased sales and he received several clinical awards for his accomplishments. Dr. Zografidis first joined Wyeth in 1998 as a Product Manager. During his tenure until 2010, he had increased responsibility as Medical Liaison for the transplantation, haemophilia and oncology divisions where he was instrumental in driving sales in assigned European territories.
Informative post from Yahoo (I think the info came from IR) -
The Anavex laboratory was very active from the company’s inception in 2007 until a few years ago. The task of developing several promising compounds has been accomplished, one of which (ANAVEX 2-73) is now in a Phase 2a clinical trial. In the meantime, Anavex also in-licensed another promising compound, ANAVEX 3-71 (formerly AF710B), from a lab of the Weizmann Institute. The company’s focus has now shifted towards clinical development, which cannot be performed in the lab.
In terms of the number of participants in the Phase 2a trial, this is because of the adaptive design of the trial (versus a trial that includes patients receiving a placebo). Here is a summary of comments made by Dr. Tasos Zografidis, the Vice President Clinical Operations of Anavex, and Dr. Christopher Missling, President and CEO, in a conference call earlier this year, which provides additional insight into the reasons Anavex is using an adaptive trial design.
+++++
TZ: For background information, there are two approaches in a clinical trial. One is the placebo controlled study. Here you have to estimate the number of patients needed if you are testing a hypothesis since you need a certain power; you need a certain number of patients. However, the methodology that we are using is very different, we just measure whatever effect is there. If you measure the effect and are able to reproduce it mathematically (mathematical modeling), then you can calculate the number of patients needed so as to see the effect. By using the adaptive trial methodology with population PK modeling, we are implementing mathematical modeling along with probability density function statistical methodology. That means that the results are looked at in confidence intervals. In the first approach you first estimate the number of patients and then you "see" the effect. In the second approach you first measure the effect and then you calculate the patients needed so as to truly "see" the effect. So, these are two opposite approaches with same outcome.
CM: We want to get a signal and the adaptive clinical trial allows us to increase the dose or decrease the dose until we see a signal. The mathematical model that Tasos speaks of sufficiently allows us to measure the data from these 32 patients because we are measuring many data points in this trial, from blood samples and the various cognitive tests, which allows for sufficiently precise data to learn how the drug works in order to select the number of patients needed for a Phase 3 pivotal trial. The number could range anywhere from 100 to 300 and the goal is to figure that number out.
The key is to understand the difference between a statistical standard trial, which is based on the placebo versus active dose in a number of patients, and the adaptive trial design statistical method used. The FDA has written a very eloquent guideline which you can find on the fda.gov website (http://www.fda.gov/downloads/Drugs/Guidances/ucm201790.pdf). The FDA states that with the adaptive trial design, which we are using, you need fewer patients, you are able to do this in a shorter period of time, you are more likely to demonstrate the effect of the drug, and you are getting more information on the treatment effect as well as a better understanding of dose response information in subgroups. Lastly, you are able to identify and optimize the parameters needed for Phase 3 effects. So, this Phase 2a trial is a very important stepping stone and building block for a successful Phase 3 trial. We want to avoid the same failure that the other Alzheimer drug trials experienced, and by implementing a different, innovative trial design for ANAVEX-73 in Alzheimer’s treatment, we are leading a more efficient study than a conventional study.
toot, here is a data release scenario that hasn't been discussed yet -
Dr. Missling releases first patient data for Part B at 3 months, including the MMSE and Cogstate scale change numbers. Below is what was given to us in the first patient data for Part A -
Preliminary measured Mini Mental State Examination (MMSE) and Cogstate scale changes are consistent with the observed trend of the cognitive EEG/ERP effect. The safety profile of ANAVEX 2-73 during Phase 2a appears consistent with the Phase 1 data; additional clinical data of the trial will be presented at future medical meetings.
To me, data from Part B would have a much larger impact than more Part A data. But then, to me, Part A data will only continue to be remarkable as 2-73 is dose optimized.
Anavex to Present at 2015 Ladenburg Thalmann Healthcare Conference
AVXL has plenty of cash on hand to finish the Phase 2A trial. The Company has been very clear about their intentions to partner after Phase 2A.
No loans
No dilution
No liabilities
Do some homework on AVXL
Of course AVXL is losing money. They're an emerging biotech.
You posted -
It's just wrong to post what you did in an attempt to mislead investors. Here's the facts -
From latest 10-Q -
Current Assets $ 7,977,385
Current Liabilities $ 1,351,567
Working Capital $ 6,625,818
From latest presentation -
Cash Burn: ~$300K/month
Well-capitalized to achieve key clinical readouts ?
No debt
I wouldn't be surprised if "by the end of the year" has a nice time cushion built in to avoid disappointment.
It all depends on what data the Company wants to release and when. There has been a lot of Part B data collected already. The first patient was dosed on January 12th. That patient, and possibly others, should have completed 6 months of Part B. Many patients should have completed over 3 months of Part B already.
AVXL expects to have Part A completed by the end of the year -
http://www.anavex.com/?news=anavex-presents-positive-initial-phase-2a-study-data-with-anavex-2-73-showing-early-evidence-of-improving-cognition-in-patients-with-alzheimers-disease-at-aaic-2015
“We are cautiously optimistic given the encouraging feedback and the preliminary cognitive data. We look forward to the full ANAVEX 2-73 Phase 2a trial results,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “As of today, we have enrolled two-thirds of the patients. We expect the trial to be fully enrolled and to have PART A completed by the end of the year.”
The Biotech Showcase Conference is a very popular event and most all of the up and coming biotechs will be there whether they have data to report or not.
AVXL's first data was given at the Alzheimer’s Association International Conference® (AAIC), more of a science specific conference.
We won't know what the plan is until they tell us. I'm guessing that we'll be given more interim data and final data at CNS conferences.
The May presentation pegged the cash burn at ~300K per month. This while the Phase 2A trial is running.
Anavex has ~$8,000,000 cash.
Grant money is a possibility.
If AVXL plans on uplisting after the completion of Phase 2A, Part A, they will need cash to fulfill the shareholder equity requirement.
The Lincoln Park financing from 2013 was resurrected on July 8th, 2015. AVXL could raise a lot of cash from this if they choose to do so -
As of May 14, 2015, there were 77,243,580 shares of our common stock outstanding, of which 48,215,168 shares were held by non-affiliates, excluding the 591,858 shares that we have already been issued to Lincoln Park under the Purchase Agreement. Although the Purchase Agreement provides that we may sell up to $10,000,000 of our common stock to Lincoln Park, only 9,975,267 shares of our common stock are being offered under this prospectus, which represents (i) 250,000 shares that we issued to Lincoln Park in the Initial Purchase, (ii) 341,858 shares that we issued to Lincoln Park as a commitment fee, (iii) an additional 9,250,000 shares which may be issued to Lincoln Park in the future under the Purchase Agreement, and (iv) 133,409 shares that we are required to issue proportionally in the future, as an additional commitment fee, if and when we sell shares to Lincoln Park under the Purchase Agreement. The additional commitment shares are issued pro rata as Lincoln Park purchases up to $10,000,000 of our common stock as directed by us. For example, if we elect, at our sole discretion, to require Lincoln Park to purchase $100,000 of our stock then we would issue 1,334 shares of the pro rata commitment fee which is the product of $100,000 (the amount we have elected to sell) divided by $10,000,000 (the total amount we can sell Lincoln Park under the Purchase Agreement multiplied by 133,409 (the total number of pro rata commitment shares). The pro rata commitment shares will only be issued pursuant to this formula as and when we elect at our discretion to sell stock to Lincoln Park. Lincoln Park may not assign or transfer its rights and obligations under the Purchase Agreement. If all of the 9,975,267 shares offered by Lincoln Park under this prospectus were issued and outstanding as of the date hereof, such shares would represent approximately 13% of the total number of shares of our common stock outstanding and 20% of the total number of outstanding shares held by non-affiliates, in each case as of the date hereof. If we elect to issue and sell more than the 9,975,267 shares offered under this prospectus to Lincoln Park, which we have the right, but not the obligation, to do, we must first register for resale under the Securities Act any such additional shares, which could cause additional substantial dilution to our stockholders. The number of shares ultimately offered for resale by Lincoln Park is dependent upon the number of shares we sell to Lincoln Park under the Purchase Agreement.
http://www.sec.gov/Archives/edgar/data/1314052/000106299315003758/form424b3.htm#page_9
Maybe, maybe not -
I don't envision Dr. Missling waiting that long to release more data.
I think he is a stock market savvy guy as witnessed by his timely buys before the 7/22 data release.
An Alzheimer's Disease or CNS conference would be more appropriate for next data, IMHO.
Just a little thinking out loud -
The 7/22 data release date lined up closely with the 6 month Part B completion duration for the first patient who was dosed on 1/12. There may have been a couple more patients coming up on the 6 month limit and certainly others with 5 month, 4 month and 3 month durations into the Part B testing.
At the patients request, Anavex decided to seek permission from the FDA to extend the Part B dosing duration from 6 months to 12 months. This extension request is material news and had to be PR'd.
I think this in part drove the timing of the first data release.
With the data in hand for the patients with lengthy Part B participation, would Anavex have decided to extend Part B if they weren't seeing steady improvement in the results?
NO!!!
No, companies don't have to wait 6 months. However, the CEO and other insiders can't buy or sell their company's stock while in possession of material, nonpublic information about their company.
Illegal insider trading refers generally to buying or selling a security, in breach of a fiduciary duty or other relationship of trust and confidence, while in possession of material, nonpublic information about the security. Insider trading violations may also include "tipping" such information, securities trading by the person "tipped," and securities trading by those who misappropriate such information.
Examples of insider trading cases that have been brought by the SEC are cases against:
•Corporate officers, directors, and employees who traded the corporation's securities after learning of significant, confidential corporate developments;
•Friends, business associates, family members, and other "tippees" of such officers, directors, and employees, who traded the securities after receiving such information;
•Employees of law, banking, brokerage and printing firms who were given such information to provide services to the corporation whose securities they traded;
•Government employees who learned of such information because of their employment by the government; and
•Other persons who misappropriated, and took advantage of, confidential information from their employers.
https://www.sec.gov/answers/insider.htm
I'm soooo looking forward to the next data release.
Whenever that might be.
I'm not sure where the info came from, maybe IR, with regard to your question. At any rate, it's widely believed that patients start Part B as soon as they complete Part A.
This would mean that at least the first patient has completed 6 months of dosing and probably a few have completed 3 months of dosing.
Thanks for the info. I'll definitely send them my thoughts.
Big difference as compared to AVXL's data release.
AVXL reported on 12 patients. GNSZ reported on ???
I think the Company deserves the credit for the dump today. For them to hype today's data release before hand and then not give the number of patients involved along with the data is nearly criminal.
I have to assume that the data PR'd was for 1 patient, maybe 2.
The Company is responsible for the sell-the-news, IMHO.