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In regards to Energous, a partner is anyone that signs an agreement to include Wattup wireless technology within their products. This usually takes time because of the mechanics involved to incorporate their technology for mass production.
See this Investor Presentation in the link below...especially page 23.
https://d1io3yog0oux5.cloudfront.net/_91e74fd3ac79c71108f6c600e4fc81b8/energous/db/285/3038/pdf/WATT+Investor+Deck+March+2024+2.pdf
If their technology isn't practical, then why are all of these major corporations signing up as partners?
Recent Partnership Momentum
Energous and Velociti — which deploys advanced enterprise technology solutions to some of the largest brands in the world, joined Energous as a preferred system integration partner and worldwide value-added reseller (VAR) for its technology. The partnership provides expansion opportunities into new markets, applications and customers across retail, healthcare, logistics, warehousing and more.
Energous and WiGL — a developer of touchless wireless charging for IoT devices for wireless power networks, to develop and commercialize IoT products that will be wirelessly powered over distance (tWPT). The U.S. Department of Defense’s Air Force Research Lab funded the project's first two phases. The third and final milestone of the partnership to develop and design WiGL’s touchless Wireless Power Transfer (tWPT) product was completed in February 2024, successfully meeting Federal Communication Commission (FCC) compliance.
Energous and Identiv — a global digital security and identification leader in the Internet of Things (IoT) have partnered to bring real-time asset tracking to supply chain and logistics applications. This collaboration aims to wirelessly power Identiv’s ID-Pixels tags with Energous PowerBridge technology, enabling accurate and reliable sensor measurements that can be used throughout the supply chain, including in cold chain logistics.
Energous and InPlay — a fabless semiconductor company, to demonstrate a battery-free temperature and humidity IoT sensor solution. This innovation harnesses the strengths of Energous' PowerBridge technology and InPlay's cutting-edge Bluetooth low-energy beacon system.
Energous and Veea — a leader in integrated smart edge connectivity, computing and security technologies, to combine wireless power and edge computing for real-time asset tracking in rapidly growing IoT sectors. The combined technologies were showcased in a proof of concept at the AT&T Mexico Innovation Lab in Mexico City.
You need to read the latest information to understand where the company is heading now.
https://ir.energous.com/news-events/press-releases/detail/786/energous-corporation-reports-2023-results
Mutual Recognition Agreements (MRAs) between the EMA and other countries (including Australia)
The European Union (EU) has signed mutual recognition agreements (MRAs) with third-country authorities concerning the conformity assessment of regulated products. Such agreements contain a sectoral annex on the mutual recognition of good manufacturing practice (GMP) inspections and batch certification of human and veterinary medicines.
MRAs allow EU authorities and their counterparts to:
- rely on each other's GMP inspection system;
- share information on inspections and quality defects;
- waive batch testing of products on import into their territories;
Each agreement has a different scope.
MRAs are trade agreements that aim to facilitate market access and encourage greater international harmonisation of compliance standards while protecting consumer safety.
These agreements benefit regulatory authorities by reducing duplication of inspections on each other territory, allowing for greater focus on sites that could have a higher risk and broadening the inspection coverage of the global supply chain.
They also facilitate trade in pharmaceuticals because they reduce costs for manufacturers by reducing the number of inspections taking place at facilities and waiving re-testing of their products upon importation.
EMA role
The European Commission is responsible to negotiate MRAs with partner countries on behalf of the EU. The European Commission may consult EMA on regulatory and scientific questions as part of this process.
EMA is involved in operational activities once the MRAs are in place, including:
- facilitating cooperation on inspections, including joint inspections and exchange of information on inspections;
- facilitating exchange of information and being the relevant contact point between the EU GMP inspectorates and partner authorities;
- operating the EudraGMDP database and connecting partners countries to it;
- responding to queries on the implementation of the MRA;
- involving partners countries in relevant EMA working groups, such as the GMP/Good-distribution-practice Inspectors Working Group;
- coordinating MRA maintenance activities.
Overview of Specific MRAs
Australia, Canada, Israel, Japan, New Zealand, Switzerland and the United States
https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/mutual-recognition-agreements-mra
Article by Forbes Magazine
This article was written in 2015...but it tells you how much they've accomplished over the last 9 years!
An In-depth Look At Energous, Its IPO, And Its Disruptive Approach To Wireless Power
George Holmes had decided he was done with wireless power companies when a friend asked him to check out a little startup based in Pleasanton, CA. “It’s the best wireless power deal on the planet,” his friend said.
“I don’t think so,” Holmes said. “I’ve been there. I’ve done that. I’ve got that T-shirt.”
Holmes, a veteran sales executive, had left a top job at Lucent Microelectronics (now Agere Systems) to work with smaller companies, including two wireless power startups. He had a knack for picking companies and shaping sales teams that delivered triple-digit growth. But the wireless power companies hadn’t taken off, and Holmes thought he knew why.
“If you can’t power four devices simultaneously at fifteen feet, then you don’t have anything,” he bluntly told Michael Leabman, the founder of Energous, which at the time was called DvineWave, after he finally agreed to make the call.
Holmes thought he was ending the conversation. No one had been able to develop a workable system to send wireless power to smartphones at a distance. The only commercially viable solutions involved placing a phone directly on a pad. Companies like Intel and Qualcomm were struggling to transmit power a few inches so that the transmitter could be hidden underneath a desk.
“I think I can do that,” Leabman said quietly. Holmes was dumbfounded. Then Leabman explained.
Leabman, a soft-spoken engineer, is one of those very smart people who manages to combine genuine decency with relentless drive. Starting as an undergraduate at MIT, Leabman spent more than a decade learning everything he could about electromagnetic waves. His knowledge wasn’t just theoretical. Over the years, he has launched companies that delivered better WiMAX and offered broadband Internet service to aircraft in flight and cruise ships at sea. Energous was his fourth venture. Based on a foundation of mathematical algorithms developed over more than a decade, Energous was Leabman’s biggest and boldest idea yet.
Even among the small number of wireless power researchers, Leabman’s experience made him an anomaly. If he could do what he said he could, Energous might well have what Warren Buffett likes to call an economic moat—a long-lasting competitive advantage based on its intellectual property.
Leabman’s approach hadn’t been proven, but it made sense. He was going to take advancements that had been made regarding voice and data communications, apply them to the transmission of wireless power, and push things forward one or two orders of magnitude. Instead of four or eight antennas, his transmitters would have hundreds. Devices on the receiving end would sport tens of tiny antennas. The math involved was mind bending, but Leabman assured Holmes it was doable. He showed him an early prototype—a transmitter the size of a box fan that could power a phone five feet away.
Holmes went back to the bankers at MDB Capital Group who had initially called him about Energous. It was a good deal, he told them. There were risks, obviously, but Leabman had a shot at success.
A combination venture capital firm and investment bank, MDB specialized in helping early stage companies with disruptive technology. But unlike traditional venture firms who typically wait until a portfolio company reaches $100 million in revenue before taking it public, MDB offered a few handpicked companies the chance to go public immediately, even if their revenues were zero. They called this approach “public venture funding.” There was a logic behind it. The bankers wanted to give ordinary investors the chance to take the same outsized risks for the same massive rewards as the most elite venture funds.
Companies who successfully raised public venture funds could find themselves in a stronger position than their venture-funded peers. Being able to offer publicly tradable stock at relatively low valuations made it easier to attract engineers. Stakes of the founding team were not diluted by repeated rounds of funding, and media interest was much higher. “There are a lot of advantages to being public as you are developing the growth phase of your company,” said Ankur Desai, a member of the team at MDB that championed Energous.
In Energous, Desai saw “a ubiquitous solution that changes the way we think about energy.” Earlier that year, MDB had invested $5.5 million in the company. Desai was now helping Leabman hire an executive team. He wanted to know if Holmes had any recommendations.
Holmes suggested Stephen Rizzone as CEO. Holmes had met Rizzone in 1999, when Rizzone had stepped in as president and CEO of Ortel, an optical components company. At the time, it was Rizzone’s second CEO position, but he was already developing a reputation for helping unlock shareholder value. Together, Rizzone and Holmes, who was then vice president of worldwide sales at Ortel, sold the company to to Lucent MicroElectronics for $3 billion.
After taking each other’s measure, the men took separate paths. Rizzone joined the short roster of seasoned managers that large investors turn to when they want someone new to run things at their companies. Holmes became the go-to guy for sales expertise, building teams in sectors ranging from enterprise search to solar. But Holmes and Rizzone kept in touch. They knew who could get the job done if another big opportunity came along.
Rizzone agreed to take a look at Energous. “I saw Michael’s first-generation prototype, and I instantly was all in,” he recalled. “In the whole wireless revolution, wireless charging is the last problem to be solved.”
Blue-eyed, blond and dapper, Rizzone lived in a house in Newport Beach overlooking the harbor. He was polished, well mannered, unflappable and focused. Rizzone exuded credibility and could also be disarmingly direct. At his first meeting with Leabman, Rizzone laid out his management style. “You’re the founder, and I know that’s important,” he said. “I’ve had experience with founders, and I’ll let you know that it’s going to be a partnership. And part of that partnership is you are going to hear things you might not like. I am not going to hide anything from you.”
Leabman had already spoken with four or five other CEO candidates. None had been so brutally honest about the relationship between founder and CEO. He liked Rizzone.
As a young technical founder, Leabman was used to being told by venture capitalists that his companies needed seasoned business leadership. He had also grown used to seeing VCs and the management they hired put their personal interests ahead of the companies’ they funded. When Rizzone assured him Energous’ interest would come first, Leabman believed he meant it. But Leabman also planned to protect his company by going public immediately. It was why he had accepted funding from MDB. He intended to ensure that everyone’s interests would be aligned.
This strategy suited Rizzone just fine. “Given the potential here, we wanted to make sure everyone was completely focused on building a world-class company,” he said in an interview with Forbes.com more than a year later. “We wanted access to the public markets, and we wanted that access to be based on our ability to execute.”
Rizzone also knew Energous’ success would be dependent on its engineering team, which at the moment consisted solely of Leabman. Having public shares would be an invaluable recruiting tool. Energous would be able to offer a small company environment where an engineer could have an immediate impact, along with an early employee equity package that, when it vested, would be liquid.
Rizzone wanted the job, and he had the perfect candidate in mind to head sales and marketing: George Holmes. “From a sales and business development perspective, George is one of the best enablers that I’ve had the good fortune of working with,” he told Forbes.com.
Rizzone also hired Thomas Iwanski, an executive he had worked with at multiple companies, as a financial consultant as the interim financial officer. At the same time, Iwanski was also advising Medbox, a company that was seeking to commercialize marijuana vending machines. The relationship with Iwanski would prove to be short-lived.
In October 2013, the new team got down to work. Over the next six months, they would rename the company, which was officially launched as Energous in January 2014, hire dozen of experienced engineers and raise $27.6 million in a successful IPO. On March 28, 2014, the stock’s first day of trading on the Nasdaq stock exchange under the symbol “WATT,” it soared from $6 to $9.5. This was a remarkable performance for a company that had no history of operating revenue and had warned it would need additional capital to achieve its business goals.
Desai, now a founding partner of Liquid Venture Partners, said the IPO was targeted at investors who were comfortable risking capital on an early-stage company. He described investing in Energous today as akin to investing in companies like SnapChat or Uber that initially raised money at modest valuations and are now worth billions of dollars. “The public market investors deserve the opportunity to invest in these sorts of companies,” Desai said.
“The model is not that different from biotech, when companies go public very early in their life cycles,” explained Ben Padnos, an independent investor who has participated in both VC and public venture investments. “For the average Joe investor you need to go in with your eyes wide open. This is for the high-risk allocation of a diversified portfolio.”
At the same time, Padnos, who has blogged about his investment in Energous on Seeking Alpha, believed Energous offered one of those rare opportunities that is usually only available to a handful of the most elite venture capital firms and their clients. It had strong intellectual property—to date it has filed 170 patents, and its licensing model eliminated the cost of maintaining inventory and the risk of manufacturing. One day, billions of devices would be charged by wireless power. If the leadership team executed, there would be an enormous market for Energous’ technology.
Rizzone had sought to quickly put together a strong executive team, but one hire was not working out. In June, Energous ended its arrangement with Iwanski after Medbox became embroiled in charges of accounting improprieties. Rizzone said he knows Iwanski to be a person of high integrity, but that he needed to do what was best for Energous, which meant ensuring the company had no continuing connection to Medbox, which was involved in a growing scandal. (Rizzone and Holmes, who has also worked with Iwanski, asked me to clarify that they do not believe Iwanski to be involved in any questionable activities at Medbox but that they were concerned his dual roles would cause Energous to be associated with Medbox when in reality the two companies have never been connected in any way.)
Energous had a narrow window to introduce its technology to consumers who were anxious to reduce electronic clutter and cords, Cell phones that charged themselves when laid on special charging mats had been available for several years, and the technology, known as inductive charging was beginning to gain broad acceptance. Toward the end of 2014. Starbucks began embedding charging mats in countertops around the United States, expanding to London in early 2015. In 2016, PCs will come with built-in wireless charging courtesy of Intel, and, if all goes well, Energous’ WattUp system for mobile charging will hit the consumer market.
Energous’s move to rapidly commercialize its technology puts it ahead of other startups focused on charging devices at a distance like Ossia, which is based in Redmond, WA, or Wi-Charge, based in Rehovot, Israel. Like Energous, Ossia delivers power to multiple devices using Wi-Fi. Ossia recently raised $9.3 million from Recruit Holdings, a Japanese venture firm, and other investors. But its transmitters are still considerably larger than Energous’ transmitters. Wi-Charge wants to power devices via the infrared spectrum, which offers short wavelengths, higher frequencies and higher power, but it is still pulling together media demos.
Rizzone’s plan is to focus first on battery backpacks and wearables, thanks to the speed of their product cycles. But those rollouts will only scratch the surface of what’s possible. With WattUp, keyboards, wireless mice, remote controls, game controllers, and children’s toys —basically any low-power device—will no longer require a constant supply of fresh batteries. “We believe this technology is well-timed and is going to be well-received by the consumer because it moves charging a device from an active to a passive process,” Rizzone told Forbes.com.
The technology is already well-received by manufacturers. By November, Energous had over 100 active partner engagements. The list added up to a Who’s Who of consumer product companies, Rizzone said. The company had planned to ink two to four joint development agreements in 2014. Instead, Energous had twelve JDAs, and four were with major global players.
“What we witnessed has been a strong market demand from all corners of the mobile and battery power devices market,” Holmes told investors attending a conference call on November 11. “The demand has been impressive and even quite overwhelming,” Holmes added. “When Global 100 players are contacting you directly, it confirms that you are doing the right things.”
This sounded like good news. But the truth was there was more demand than Energous’ engineers could handle. Rizzone told investors on the conference call that the company was at a crossroads. Energous could maintain its current rate of development and strategic partner engagement, but it would have to pass on a number of potentially high-profile opportunities. In that case, “we will likely lose a number of potential strategic partners to other wireless solutions,” he warned. Or, Energous could risk alienating its investors. It could issue more shares and use the additional capital to expand its development and support team. Rizzone announced he was planning to do the latter.
The next day, Energous opened at $9.63 and closed at $8.66. Over the next six weeks, the stock would fall as low as $7.11.
But behind the scenes demand for Energous’ stock was intensifying. The secondary round closed on December 15. Energous had raised an additional $20 million at a per share price of $7. The offering had been two times oversubscribed. Rizzone’s gamble had paid off.
Meanwhile, Leabman and his engineers had overcome some key technical hurdles. A solution that had been mostly theoretical had been successfully prototyped. Engineers had built wireless charging into a series of everyday products—televisions, speakers, routers, phones and wearables. The technology worked like Leabman always thought it would, and Energous was about to show the world.
Most companies exhibiting at the Consumer Electronics Show in Las Vegas set up a booth on the expo floor. Energous rented two suites at the Hardrock Hotel and Casino, a taxi ride away from the action. They wanted to show attendees what it would be like to live in an apartment where charging cords were optional. WattUp transmitters lit up electric lights and topped off batteries on smartphones and watches. Visitors who put a battery pack on their phone could watch their phones pair with the hidden transmitters and start charging as they moved around the room. (IPowerUp, an Energous partner, is already marketing these battery packs on their website.)
The demonstration drew attention and accolades. Engadget awarded Energous two “Best of CES 2015” awards including Best Innovation (Disruptive Tech) and Best (Connected) Home Product. Energous also landed three of the coveted honoree spots for “CES Innovation Awards.” A raft of news articles included some rave reviews. BGR (formerly known as Boy Genius Report) wrote: “It’s amazing. Period.” But other journalists wanted to know how the system compared to new rapid chargers. They also wondered about its efficiency and its safety. “There’s still a big question mark regarding its rate of charging,” wrote the Washington Post. “Another big concern is the potential higher cost of electricity, since much of it can go to waste.”
Rizzone had heard the questions before, and he tried to clear up the reporter’s confusion. WattUp isn’t designed for rapid charging, but for constant trickle-charging. Communication between the receiver and the transmitter ensure that power is only transmitted when it is needed. Energous has created software that tracks all this in detail. A restaurant or hotel could, for example, keep close tabs on how wireless power is being consumed by its customers. As a side benefit for business owners, the same communications channel that carried energy could also convey individual greetings and special offers. “The network owner/operate has the ability to deliver geolocation-based advertising,” Rizzone explained.
Energous continues working to increase the efficiency of its wireless charging system, but even the first generation of WattUp is unlikely to have a significant impact on a customer’s electrical bill. That is because the total amount of energy WattUp is providing to devices is comparatively minuscule. Charging an average cellphone costs less than $.50 a year. According to the Electric Power Research Institute, the annual cost of charging an iPad is just $1.36. The company argues that by actively tracking and monitoring devices under charge, and turning off the transmitter when no devices are present, WattUp can be even more energy efficient than what most consumers experience when they leave their devices plugged in after they are fully charged.
A basic lack of understanding of how wireless power works is one of the hurdles that Energous is facing. Concern is particularly acute around safety. Most people assume that Energous is radiating power around a room in the same way that Wi-Fi blankets an area. But while Energous uses the same portion of the electromagnetic spectrum as Wi-Fi (5.7 to 5.8 GHz) its waves are tightly focused to create small pockets of energy around the batteries that need charging.
This is how WattUp is designed to work: The transmitter and receiver first communicate over Bluetooth. It takes about a second for the system to focus. The transmitter then sends out electromagnetic waves (basically very simple Wi-Fi signals) that collect around the receiver in 3D space. Between zero and five feet, the system can transmit four watts to up to four devices each. That sounds like a lot, but it’s spread over hundreds of antennas on the transmitter and dozens of antennas on the receivor. What’s really being transmitted are micro amounts of energy, as little as a tenth of a watt, that is then aggregated at the receiver. “We are essentially receiving ten or twenty times less energy density per antenna than your phone transmits,” Leabman said.
However, the comparison between WattUp transmitters and cellphones potentially adds more confusion. The FCC requires cellphones to limit electromagnetic emissions to 1.6 watts per kilogram, a rate known as the Specific Absorption Rate or SAR rate. The SAR rate is measured by sticking a probe in a fluid-filled replica of the human head. Some phones like the new iPhone 6 and 6 Plus come extremely close to that limit when cellphone bands, Wi-Fi, and Bluetooth are used simultaneously. In contrast, the WattUp system is designed to put receivers in phones that harvest electromagnetic emissions and put them to use.
WattUp transmitters, which can potentially be built into everything from a wireless router to a TV set, use a different frequency than cellphone signals. Cellphone signals are penetrative—they go right through the human body. “The physics of our transmitter signal is reflective,” Rizzone said. “and the signals aren’t penetrative as a result.”
There is no federally developed national standard for energy transmitted through electromagnetic waves, also known as RF emissions. “According to the FDA and the World Health Organization (WHO), among other organizations, to date, the weight of scientific evidence has not effectively linked exposure to radio frequency energy from mobile devices with any known health problems,” the FCC stated on its website. But concern has persisted, and in some cases has provoked raging debates.
The FCC addresses these concerns with two sets of regulations known as Part 15 and Part 18 approval. The problem for Energous is that the rules were written for the technology that existed at the time—spread spectrum transmitters, field disturbance sensors and microwave ovens. As the company noted in its IPO filing, “the transmission of power using RF energy waves by a consumer product at the ranges we are proposing has not yet been approved and there can be no assurance that we will be able to obtain this FCC approval or that other governmental approvals will not be required.”
For Energous investors, FCC approval is the big unknown. Noting first that the technology is a “no-brainer,” Thomas Hudson, founder of the investment firm Pirate Capital, said “obviously we want to make sure the regulatory environment is accepting of this particular product.”
Energous is doing what it can to mitigate the risk. Holmes hired an experienced regulatory team to work with the FCC, and he provides updates to investors every quarter. “In Q3, we conducted tests on our early prototypes, which [were] designed to help us with our test development and planning, which [were] very successful,” Holmes told investors in November. “During the course of Q4, we will be back in the labs to continue testing of our solution and expect to be able to obtain certification for our receivers perhaps as early as the end of this year. We are very happy with our progress. And through our engagements with the regulatory bodies to date, we have received no showstoppers that would stand between us and complete certification in 2015.”
In an interview, Leabman said the company is prepared to adapt if regulators throw them a curve ball. “We have tremendous flexibility because our system is software controlled,” he said. “There is still a lot of room for innovation,” he added. “We aren’t done yet.”
The next steps for Energous are delivering reference designs to its joint development partners. Once the designs are validated and prototypes built, the partners will decide whether to move forward with licensing agreements. At that point, Energous will transition from an extremely high-risk investment with no revenue, to an extremely high-risk investment with solid prospects of revenue.
A lot could still go wrong. But one thing Energous has proven is that the power can be wirelessly sent from a small, embedded transmitter to charge multiple devices anywhere in a room. And that may well be the future of power.
Follow my reporting on wireless power on Facebook.
Elise Ackerman
Elise Ackerman
Since 1998, I've been writing about technologies and technologists on the cutting edge, who are poised to reshape the status quo in both promising and... Read More
https://www.forbes.com/sites/eliseackerman/2015/01/25/an-in-depth-look-at-energous-its-ipo-and-its-disruptive-approach-to-wireless-power/?sh=38ab76161527
Here's the bottom line on WATT...
I've researched this company going back to 2015 and read all of the hype and all of the negative articles that followed. To sum up everything, Energous has spent approximately $300 Million in R&D, administrative expenses, etc...which decimated their SP going from ~$160 to around .30 cents...which forced them to conduct a 20:1 reverse split to stay on the stock the exchange.
But the fact that they're still alive (and flourishing!) gives us the perfect opportunity to scoop up these new shares and (possibly) make a small fortune. Here's what the company looks like now...
1) They have $13.9 Million in the bank and no debt!
2) They have reduced their total cost and expenses by $4.9 Million Year over Year from 2022 to 2023. Take a peak at their recent financial results here: https://ir.energous.com/news-events/press-releases/detail/786/energous-corporation-reports-2023-results
3) They have 38 POCs (Proof of Concepts) with 3 companies fully completed and starting to manufacture their products with WATT inside!
In my humble opinion, this company is finally ready for the big leagues.
Let me know what you think after you've reviewed the financial results and listened to the earnings webcast.
Cheers!
Got it. Investor2014 is allocating 100% in AVXL.
Hey, I'm not judging. You could have the absolute best strategy.
$1 million divided by $5.09/share = 196,463 shares of AVXL
If you had one million dollars in your IRA to invest, how would you invest it? (Assuming you're 65 years old and in good health)
Break it down in percentages and specific stock symbols. Below is an example...
50% Precious metals stock = CDE
10% Real Estate = REIT stock symbol AMT
30% Money Market Fund = VMFXX
10% High Risk/High Reward = AVXL
I'll try to keep track of everyone's strategy and compare it at the end of the year. This should be interesting!
Don't forget this collabaration between the FDA and Ariana.
FDA taps Ariana KEM platform for biomarker signature analysis
Sep 9th, 2010
The US Food and Drug Administration is collaborating with Ariana Pharma, a provider of decision support software for pharmaceutical discovery, development and safety, in the agency’s efforts to improve the analysis of genomic data in support of personalised medicine.
The US Food and Drug Administration is collaborating with Ariana Pharma, a provider of decision support software for pharmaceutical discovery, development and safety, in the agency’s efforts to improve the analysis of genomic data in support of personalised medicine.
Under the collaboration, Ariana is providing its KEM biomarker technology to help FDA reviewers analyse pharmacogenomic data and patient characteristics for biomarker signatures filed through the agency’s Voluntary Exploratory Data Submission (VXDS) programme.
As things stand, the FDA notes, most pharmacogenomic data are “of an exploratory or research nature”. Accordingly, the agency’s regulations do not require the inclusion of these data in investigational new drug application (INDs), nor do they ask for complete reports on pharmacogenomic data in new drug applications (NDAs) or biologic license applications (BLAs).
Nonetheless, the FDA adds, voluntary submissions “can benefit both the industry and the FDA in a general way by providing a means for sponsors to ensure that regulatory scientists are familiar with and prepared to appropriately evaluate future genomic submissions”.
Launched in 2003 and based in central Paris, France, Ariana Pharma is a spin-off from the Institut Pasteur. Its KEM (Knowledge Management and Extraction) platform is a proprietary decision-support technology for the rapid analysis of parametric/multi-objective data, with applications ranging from drug discovery to optimisation of design and outcomes in clinical trials and early signal detection for drug safety.
According to Ariana, the KEM platform can cut the risk rate in selecting panels for biomarker development from 40% to 10%, potentially saving “billions of dollars”. The technology will help the FDA to identify systematically potential genomic ‘fingerprints’ and to develop recommendations for the analysis of genomic data prior to the submission of biomarker signatures through the VXDS programme, the company said.
https://pharmatimes.com/news/fda_taps_ariana_kem_platform_for_biomarker_signature_analysis_982469/
What do you mean by asking the question: "Wait for what?"?
My response to your original comment was based on your definition of progress...which you stated as follows: "I will agree with you once AVXL files it MAA in Europe and the FDA confirms there is a regulatory path forward for 2-73 in AD toward approval in the U.S."
I responded to your definition of progress thusly: Sheesh...if you're going to wait for those events to happen the SP would probably be north of $30.
Quote: "I will agree with you once AVXL files it MAA in Europe and the FDA confirms there is a regulatory path forward for 2-73 in AD toward approval in the U.S."
Sheesh...if you're going to wait for those events to happen the SP would probably be north of $30.
That chart looks ugly. Clearly showing a downtrend with lower lows and lower highs.
IMO, the MMs are working hard to break down any positive T/A view of AVXL. And mark my words, it was no mistake that AVXL closed at a 3-year low on Friday. They're really shaking the tree hard to get retail holders to sell.
I just added another 4,880 shares at $4.55...and I'll be adding more on Wednesday.
Thanks for the cheap shares!
Wonder what happened to Mike_dotcom? He hasn't posted in awhile.
Here's a link to their newest partner...Velociti
https://www.velociti.com
Check out their investor presentation. Very impressive!
https://d1io3yog0oux5.cloudfront.net/_dd47c7d279e648f1b844bbce5553f870/energous/db/285/3038/pdf/WATT+Investor+Deck+March+2024+2.pdf
Raja...since you're no longer invested in AVXL, I'd like your opinion of another company that I just invested in. Please go to the WATT board and tell me what you think.
Thanks.
Wow...this company has no debt and $16 Million in the bank...and the MC is $11 Million!
The science is incredible: sending power (electricity) using RF technology so you don't need batteries or wires to operate your projects.
Over 200 patents to protect their technology.
Major companies and suppliers are signing up like bees on honey.
Authorized to operate in the U.S., Europe, China, Australia, Japan, India, etc
Just completed a 20:1 reverse stock transaction
Insider buying: President and CEO just bought $100,000 back in November. (First time he's ever done that according to my research)
This seems too good to be true...but my research confirms everything.
I have added it to my portfolio.
Agreed. But if they report positive results, they will get a lot of attention from the media.
There is a silver lining for us though...
If you recall, AVXL shot up to $30/share when SAVA reported positive results. So we could ride their coattails just like we did with SAVA.
Quote: If not us and our science, then who?
There's still one more competitor that is about to release their TLR.
Annovis Bio Provides Data Announcement Update for the Phase II/III Study of Buntanetap in Alzheimer's Disease
March 20, 2024
MALVERN, Pa., March 20, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, today announced successful completion of data cleaning for its phase II/III study of buntanetap in patients with mild to moderate Alzheimer's disease (AD). Topline efficacy data is expected in April.
"We are excited to share that we now move from data cleaning to organization and statistical evaluation of data for our Alzheimer's study, which was completed in February. To clean data this fast is truly a tremendous achievement," said Cheng Fang, Ph.D., Senior Vice President of Annovis. "The team has been working hard to provide trustworthy data, and we look forward to the topline results as we plan to announce it next month."
The phase II/III AD study was a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap in patients with mild to moderate AD. This was a dose ranging study where patients received either one of three doses of buntanetap - 7.5mg, 15mg, or 30mg - or placebo on top of their standard of care for 12 weeks. Over 700 patients were screened with a total of 353 patients enrolled and 327 patients completed the study.
"We are grateful to the participants who enrolled and completed the study as well as their caregivers and families for supporting their loved one's involvement in this trial; we truly couldn't do it without them. We'd also like to thank our study partners whose teamwork and dedication allowed us to complete the study in a timely fashion," said Melissa Gaines, Senior Vice President, Clinical Operations.
AboutBuntanetap
Buntanetap (formerly known as Posiphen or ANVS401) attacks neurodegeneration by inhibiting the formation of multiple neurotoxic proteins - amyloid beta, tau, alpha synuclein, and TDP43 - thereby improving synaptic transmission, axonal transport and neuroinflammation. Dysregulation of these pathways has been shown to be the cause of nerve cell degeneration and ultimately death. By attacking these pathways, buntanetap has the ability to reverse neurodegeneration in Alzheimer's disease.
About Annovis Bio, Inc.
Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc. is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer's Disease (AD), Parkinson's Disease (PD), and other chronic neurodegenerative diseases. It is believed to be the only company developing a drug for both AD and PD designed to inhibit more than one neurotoxic protein to restore axonal and synaptic activity. By improving brain function, the company's goal is to treat memory loss and dementia associated with AD as well as body and brain dysfunction associated with PD. For more information on Annovis Bio, please visit the Company's website www.annovisbio.com and follow us on LinkedIn and Twitter.
Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company advises caution in reliance on forward-looking statements. Forward-looking statements include, without limitation, the Company's plans related to clinical trials. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those implied by forward-looking statements, including regarding patient enrollment, the effectiveness of Buntanetap and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety and tolerability of buntanetap. See also additional risk factors set forth in the Company's periodic filings with the SEC, including, but not limited to, those risks and uncertainties listed in the section entitled "Risk Factors," in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. All forward-looking statements in this press release are based on information available to the Company as of the date of this filing. The Company expressly disclaims any obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Investor Contacts:
Maria Maccecchini, Ph.D.
maccecchini@annovisbio.com
Does anyone know if WATT receives a royalty after they've sold their technology to a customer?
Been away for awhile. Sold 80% of my shares at $6.16 but am now looking to get back in if things are shaping up.
Would appreciate an update on the P2 Schizo trial?
And where do we stand with the EMA for our AD application?
Also, is AVXL going to pursue Rett? (Last I heard, we failed the P3 because of a high placebo response...but we showed strong efficacy with the rest of the patients)
Thanks.
abe
Wonder what happened to Hoskuld? Haven't seen any posts from him in awhile.
Quote: "It's not the first time the FDA has experienced this phenomena... and is why they frequently approve a drug in these circumstances, especially a safe drug. They review the entire package of trial data, OLE and REW information in the approval process... not just the p-values."
Bas2020...although I agree with the premise of your statement, can you give us a few examples for comparison?
Thanks.
abe
1 in 10 FDA-Approved Drugs Miss Primary End Point in Pivotal Trial
February 15, 2023
Kevin Kunzmann
Approximately 1 in 10 drugs approved by the US Food and Drug Administration (FDA) since 2018 were supported by pivotal trial data in which primary efficacy endpoints were missed.
In new cross-sectional research assessing 210 new drug approvals by the FDA from 2018 – 2021, a team of US investigators observed that 10% included pivotal studies wherein at least 1 primary endpoint was null based on findings.1 The new data—which come 2 years following the controversial FDA approval of aducanumab (Aduhelm) for the treatment of Alzheimer disease despite underwhelming trial efficacy outcomes2—highlight the need for improved communication and contextualization by the FDA on their regulatory decision making.
Led by James L. Johnston, MD, of the Department of Medicine at Brigham and Women’s Hospital, the New England-based investigators sought to define the frequency of FDA approvals for drugs based on nullified pivotal trial efficacy endpoints, as well as the agency’s rationale for such approvals. They highlighted aducanumab’s controversial approval in June 2021, as well as a history of inconsistent FDA decisions in instances of uncertain drug or device efficacy, as rationale for the study.
“In June 2021, the FDA granted accelerated approval to aducanumab for the treatment of Alzheimer disease despite both pivotal trials being stopped for futility with respect to the primary trial end point: change from baseline clinical dementia rating score,” the team noted. “Instead, FDA approval was based on an exploratory, surrogate marker: amyloid plaque reduction.”
Johnston and colleagues assessed the Drugs@FDA database for all New Drug Applications (NDAs) eventually approved by the FDA between 2018 – 2021; included in each NDA’s approval package is pivotal trial outcome data. They identified drug, pivotal study and end point characteristics for each drug missing =1 prespecified primary end point.
The team then characterized the FDA’s expressed rational included in the NDA approval packages, as well as details including whether postmarketing studies were prompted by the agency and whether they addressed unmet primary end points.
Of the identified 210 NDA approvals in the observed time period, Johnston and colleagues observed 21 (10.0%) that included null findings for =1 primary efficacy end point; each of the 21 drugs were approved for unique clinical indications. More than half (n = 11 [52.4%]) were first-in-class approvals; 10 (47.6%) previously received an Orphan Drug Designation; 13 (61.9%) received an expedited review pathway from the FDA. Only 3 (14.3%) required an advisory committee meeting prior to FDA approval.
Investigators observed 56 pivotal trials with 74 primary efficacy endpoints supporting the 21 drug approvals—but 5 approvals (23.8%) were supported by a lone pivotal trial. On average were >1 null primary efficacy end point per FDA approval (n = 27).
The team additionally noted 4 drugs were each approved based on a single pivotal study with null results for all its pivotal primary efficacy end points:
Naxitamab for high-risk refractory or relapsed neuroblastoma
Tazemetostat hydrobromide for epitheloid sarcoma
Migalastat hydrochloride for Fabry disease
Asparaginase erwinia chrysanthemi for acute lymphoblastic leukemia and lymphoblastic lymphoma
The FDA had rationalized their approval for 13 of these drugs (61.9%) based on the success of =1 other pivotal trials;they highlighted positive secondary or exploratory end points for 10 approvals (47.6%); and highlighted favorable post hoc analyses in 7 approvals (33.3%).
Investigators noted limitations in their assessment including a singular focus on pivotal trials supporting NDAs, as well as their inability to analyze withdrawn or rejected NDAs due to their unavailability in the FDA’s public database.
However, they concluded their findings “underscore the complexity of regulatory decision-making,” noting the prevalence of drugs approved with null primary end point findings but an overall portfolio evidencing efficacy of the drug.
“For other drugs…the evidence of efficacy was less clear,” they wrote. “Greater transparency regarding FDA decision-making could increase clinician, patient, and payer confidence in novel drugs and improve clinical use.”
They additionally called for more prioritization and timely completion of postapproval trials addressing uncertain areas of clinical efficacy for approved drugs.
https://www.hcplive.com/view/1-in-10-fda-approved-drugs-miss-primary-end-point-pivotal-trial
Quote: Someone [Bristol Meyers] just paid 14b for a company offering a Muscarinic Receptor Agonist.
Karuna Therapeutics, Inc. is a clinical-stage biopharmaceutical company.
The Company creates and delivers transformative medicines for people living with psychiatric and neurological conditions. Its pipeline is primarily built on the therapeutic potential of its product candidate, KarXT (xanomeline-trospium), an oral modulator of muscarinic receptors that are located both in the central nervous system (CNS), and various peripheral tissues. KarXT combines xanomeline, a novel muscarinic agonist, with trospium, an approved muscarinic antagonist, to preferentially stimulate muscarinic receptors in the CNS.
The Company is developing KarXT for the treatment of acute psychosis in adults with schizophrenia, as well as for the treatment of psychosis in Alzheimer's disease (AD). The Company is also engaged in developing its investigational TRPC4/5 candidate, KAR-2618, for the treatment of mood and anxiety disorders, and plan to provide details regarding the expected development of KAR-2618.
Doc or Raja...either one of you guys taken a larger position in AVXL yet?
If not, would like know your reasons. Thanks
Although I love the price action, I'm nervous as to why it's taking so long for the Rett P3 trial results. One of our competitors (BIVI) had their SP drop almost 80% after reporting problems collecting data from all of their sites. (See below)
BioVie Data for Alzheimer's Treatment Endpoint Misses Statistical Significance
November 29, 2023
BioVie said Wednesday that its Alzheimer phase-3 trial wasn't able reach statistical significance due to too many exclusions to its study.
BioVie said Wednesday that the third trial phase for its drug NE3107, an Alzheimer's disease treatment, showed positive results, but missed its primary efficacy endpoint after excluding much of its data due to protocol violation during the pandemic.
Originally, the trials began with 439 patients across 39 sites during the Covid-19 pandemic, and BioVie later found that it was in violation at 15 sites of protocol and good clinical practice, leading it to exclude all patients from those sites.
The positive data it did collect was from a 57 per-protocol patient pool. While that data found the treatment is biologically active and might have impact on cognitive, functional, and biomarker endpoints, "the data missed statistically significance due to site exclusions."
Shares halted trading at 07:58 ET before releasing the update. The stock was up 3% in premarket trading at $5.12 before being halted. [Now trading at $1.36/share]
By Adriano Marchese
Start at the 2 minute mark.
https://www.kvpr.org/local-news/2023-11-15/congressional-committee-completes-report-into-illegal-reedley-medical-lab
It's my understanding that there are several other illegal bio labs in the U.S.
Got it. Thanks for clarifying.
I disagree. If the SAE was drug-related, they would have to include all of the negatives into the final TLD. If the SAE is not drug-related, then they won't include them into the final TLD. Hence the delay.
Good post, boi.
Getting the EMA to accept our data for pre-submission allows Anavex to complete the full submission when our OLE is finished. The beauty of this scenario is the timing because every company must go through the pre-submission process.
By submitting our data for pre-submission now, allows the EMA to go through their normal evaluation process...which takes 6 - 7 months. By the time they're finished evaluating everything, we will have our OLE data ready to be submitted for full approval.
THAT is good management.
*********************************************************************************************
":...The Marketing Authorisation would allow direct market access throughout the European Union for oral blarcamesine for the treatment of Alzheimer’s disease. There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council...."
"...We have met the European Agency several times in meetings and we have shared the data which is not yet published, which is the published date of -- the planned published communication of the full data of the Alzheimer Phase 2b/3 study. And we were from this meeting recommended to proceed with this application, full approval application. And that's what we proceeded with last week accordingly...."
"...Full data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized clinical trial will be published in an upcoming peer-reviewed journal..."
Since you come from Carl Icahn's School of Management Accountability, I thought you'd like to see how his company is doing.
Michael Dell mocks the cratering of Carl Icahn's stock
Tech billionaire Michael Dell has let loose with a barbed swipe against his arch-nemesis Carl Icahn, making fun of the famed investor's sinking stock price, in a continuation of a years-long feud between the two magnates.
The #PlayNiceButWin hashtag is a reference to the title of Dell's 2021 autobiography titled, "Play Nice But Win: A CEO's Journey from Founder to Leader." In the book, Dell skewered Icahn as a stooped and shuffling old man focused purely on making life difficult for the companies he was targeting but with few ideas on how to run them.
Dell's tweet, which showed Icahn Enterprises' stock down -80.7% in the last 10 years while the stock market soared, was liked by Nathan Anderson, the activist short seller who runs Hindenburg Research. Earlier this year, Anderson targeted Icahn Enterprises, saying both Icahn and his publicly traded investment vehicle were overleveraged in the face of years of trading losses. Anderson has bet against Icahn Enterprises and the campaign has caused its stock to plunge by more than 60% in 2023.
For his part, Icahn has said Anderson's Hindenburg has launched a disinformation campaign that distorts the financial situation at Icahn Enterprises (IEP) in an effort to make money from the falling stock. A representative for Icahn didn't immediately respond to a message seeking comment.
Dell is not part of the Hindenburg effort, but the bad blood between Dell and Icahn dates back over a decade, when Icahn tried to deep six Dell's $25 billion effort to take his namesake computer company private back in 2013.
After announcing the company's intention, Icahn acquired a sizable stake in the firm in an effort to scotch the deal, saying the proposed buyout offer was too low and amounted to a move by Dell to steal the company from shareholders on the cheap.
Icahn then teamed up with another shareholder to make a counter offer, prompting Dell and his partners to have to raise their price. Dell was ultimately successful in taking the company private, but at a significantly higher price. After losing the fight, Icahn called Dell a dictator.
Dell responded by calling Icahn " a bad guy."
"He lies. He has no ethical boundaries. He will say anything, do anything. I have no time for him," Dell said at a conference the following year.
The contretemps flared up again in 2018, when Dell made a move to buy out investors in DVMT, a holding company that tracked his ownership stake in publicly traded software company VMware (VMW), in an effort to take Dell back into the public markets.
Icahn swooped in and acquired an 8.3% stake in DVMT in an attempt to scuttle the deal, saying Dell and his partners at private equity firm Silver Lake were trying to steal the company.
"You've got two guys that are going to make $11 billion," he said on CNBC in 2018. "Eleven billion dollars for doing nothing. It's unrivaled even on Wall Street's standards."
In a shareholder letter, Icahn declared war.
"I intend to do everything in my power to STOP this proposed DVMT merger," the letter said. "In my opinion, it is better to have peace than war. I still enjoy a good fight for the right reasons, and in the current situation, I do not see peace arriving quickly!" he wrote.
Ultimately, Dell prevailed but was forced to pay a $1 billion settlement to DVMT shareholders who had sued arguing they were short changed. Dell later spun off VMWare and an agreement was reached last year to sell it to Broadcom for $61 billion.
Dell's recent swipe at Icahn Enterprises was directionally correct, but not completely accurate because it did not include dividends. According to FactSet, Icahn Enterprises has returned -46.6% over the last 10 years, compared to a 201.9% return for the S&P 500 SPX.
Meantime, the stock of Dell Technologies (DELL) is up more than 500% since Dell took the company public again in 2018, giving the company a market capitalization of some $53 billion and suggesting Icahn might have had a point a decade ago that Dell was taking the company private on the cheap. Dell has long argued that he could not have initiated the big changes required to make the company successful as a public company.
-Lukas I. Alpert
November 15, 2023 (MarketWatch)
By Lukas I. Alpert
This content was created by MarketWatch, which is operated by Dow Jones & Co. MarketWatch is published independently from Dow Jones Newswires and The Wall Street Journal.
Because every time he's announced TLR for a trial, AF and other FUD naysayers claim that the FDA will never accept the data. By first submitting all the data to the FDA and waiting for their acceptance, the FUD-sters can't make any false accusations...or at least reduces their opportunity to do so.
It's my opinion that TGD wants to make sure the FDA has accepted our NDA before he announces the TLD for Rett.
I did a quick search and found the company below received a rejection letter from the FDA...but they never informed their shareholders that they applied for a New Drug application. [If you want more examples, you'll have to do your own research]
******************************************************************************************************
Denali Therapeutics Announces The Co. Received A Formal Clinical Hold Letter And Is Moving Forward To Address The FDA's Observations Related To The Preclinical Toxicology Assessment And To Provide The Information Requested To Initiate Clinical Studies
February 14, 2022
As previously announced, Denali Therapeutics Inc. (“Denali”) was informed on January 12, 2022, via e-mail communication from the U.S. Food and Drug Administration (FDA) that the DNL919 Investigational New Drug (IND) application to begin clinical testing was placed on clinical hold. Denali has now received a formal clinical hold letter and is moving forward to address the FDA’s observations related to the preclinical toxicology assessment and to provide the information requested to initiate clinical studies, including proposed changes to the clinical trial protocol, the informed consent form, and the investigator brochure. Denali intends to provide an update once a clear path forward has been established.
Agreed. Even Doc328 stated that some companies submit NDAs and don't notify their investors until after they've received acceptance from the FDA of their application. This is exactly what I think Anavex has done.
Let's be real here folks, Anavex has had plenty of time to prepare the TLR for the Rett Excellence trial results.
Since they haven't disclosed the results, I'm assuming that TGD has opted to submit the full data to the FDA and is waiting to hear back for our NDA acceptance. I could be wrong of course...but this is my theory.
Yes. I meant to say webcast and conference call. Thanks for catching that.
Since Anavex has chosen this Monday to release their EOY financials and provide an update on the execution of the Company’s growth strategy, I'm expecting some very upbeat news.
It's common knowledge that companies release good news at the beginning of the week so their SP gains momentum throughout the week. (A good example of this rule was Monday's announcement regarding our EMA relationship)
OTOH...companies will almost always announce bad news at the end of the week on Thursday and Friday; sometimes waiting until the market closes on Friday. This (supposedly) allows the investors to cool off over the weekend instead of dumping their shares throughout the week.
Takes a lot of guts to schedule your EOY financial results on a Monday...with a Q&A video immediately afterwards. Unless of course you feel really confident about the company's future.
Management will host a conference call on Monday November 27, 2023, at 8:30 am ET to review financial results and provide an update on the execution of the Company’s growth strategy. Following management’s remarks, there will be a question-and-answer session.
Quote: The EMA can expedite by 60 working days; they can also delay.
Anavex has the chance to ask for expedition six months from now.
Great. Hopefully we'll hear something around May, 2024 regarding an expedition of our drug with the EMA. Thanks boi