Is Northwest Biotheraputics a Buy Ahead of Its Brain Tumor Vaccine Clinical Data Release?

When it comes to winning biotech stocks this year, coronavirus vaccine developers automatically come to many investors’ minds. However, one of the top-performing stocks in the sector is Northwest Biotherapeutics (OTC:NWBO), which focuses on immunotherapies that treat cancer, and has returned a staggering 408% since January.

The main reason why investors are so excited about Northwest Biotherapeutics’ prospects is that the company’s 14-year-long phase 3 clinical trial to evaluate its one and only immunotherapy candidate, DCVax-L, as a treatment for glioblastoma, has concluded. Should you consider buying the stock in anticipation of the data release? Let’s find out together. 

3-D illustration of a dendritic cell.

Image source: Getty Images.

Treatment background

Glioblastoma is a deadly form of brain cancer prevalent in up to 15% of people with brain tumors. Even after patients receive standard of care (SOC) treatments consisting of surgery, chemotherapy, and radiotherapy, their median survival time comes down to just 15.5 months in historical studies. DCVax-L is an experimental immunotherapy that seeks to stimulate patients’ own immune systems to fight cancer growth. 

The potential biologic has been in phase 3 clinical trials since December 2006. In the study, all glioblastoma patients receive SOC treatments, while a random portion also receives DCVax-L via upper arm injections. A key trial endpoint requires at least 233 patient deaths out of a total of 331 participants enrolled to calculate a survival benefit for DCVax-L, if any. The company completed its study on July 24, and the data is currently being reviewed by statisticians. In the meantime, speculations on the results have ranged from wildly enthusiastic to pessimistic from excited investors and short-sellers. 

The bullish case

The bullish case for Northwest Biotherapeutics stock is straightforward: The DCVax-L clinical trial was supposed to wrap up as early as November 2016, but had to keep going because the projected number of deaths had not occurred by then.

Around the time when the trial was enrolling, only 3% of glioblastoma patients who received SOC survived over five years. Due to extremely low survival rates for patients who receive SOC treatments, bullish investors argue that there is no other logical explanation for the clinical study going into overtime than DCVax-L keeping patients alive longer than expected. 

The bearish case

The bearish case is a lot more complicated.

Clinical trials investigating experimental biologics for deadly diseases with a lack of therapeutic options usually have pre-planned interim analyses. DCVax-L’s phase 3 trial had two such analyses built into the study.

The analysis is conducted by an independent data-monitoring committee (DMC) that can recommend that the trial stop early if an experimental therapy demonstrates statistically meaningful efficacy against SOC treatments. This way, the biologic can quickly advance to the approval stage in order to save more lives.

Northwest Biotherapeutics’ DMC carried out two interim analyses on the DCVax-L study in 2017 and 2018 (more on this later). Both times, however, the company published the DMC’s findings as blinded, and the trial continued. Unfortunately, that doesn’t make any sense at all in the context of

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You might actually be able to legally buy weed soon after election if N.J. voters approve referendum, top lawmaker says

EDITOR’S NOTE: NJ Cannabis Insider produces exclusive weekly content and monthly events geared toward those interested in the marijuana and hemp industries. To subscribe, visit njcannabisinsider.biz.

New Jersey’s medical marijuana dispensaries could begin selling recreational marijuana to the public shortly after voters approve a ballot question seeking to legalize it, according to a state lawmaker involved in potential legalization.

Sen. Nick Scutari, D-Union, said Tuesday during an interview broadcast live on NJ.com’s Facebook page that he hopes dispensaries are preparing to have more marijuana available and exceed the need of their patients to begin selling to customers over the age of 21.

“The currently operating medical cannabis dispensaries would have an opportunity to sell to the general public for people over 21, if they can certify that they enough product to satisfy their patients that they’re already treating,” Scutari said.

“We might be able to flip the switch and people might be able to get marijuana, legally, right after the vote,” he said.

That’s a big if, because there are 92,000 registered patients, and the dispensaries have long struggled to supply cannabis to the state’s registered patients. Patients have complained about long lines and drives, as well as product shortages, in the limited program. The number of patients has ballooned since Gov. Phil Murphy took office and signed legislation expanding the list of medical conditions that make a person eligible for a medical marijuana card.

But this is the first time that Scutari or anyone intimately involved with cannabis law and public policy has said that the intent is to start selling this year. Insiders and industry experts have said the market would not be ready until sometime in 2021.

“My top priorities are to get it passed, and secondly, let’s get it passed quickly,” Scutari said. “It’s not like we didn’t know this was coming, so we already have a draft that we are continually working on. Right now we are working with co-sponsors and the governor’s office. We want to be able to get this thing passed quickly.”

“Finally, I think one of the most important things is to allow people to buy legal cannabis immediately,” Scutari said. “My hope is the medical dispensaries are going to get up to speed — if they are not already — to sell the adult, 21-and-over market right away.”

But Jeff Brown, assistant commissioner of the Department of Health who oversees the medical marijuana program, said logistical concerns remain.

“If it happened tomorrow, I don’t think we have an operator that would be ready to start selling adult use,” he said during a NJ Cannabis Insider webinar Tuesday that followed Scutari’s interview. “They still have a lot of work to do.”

Brown said the department has pushed operators to expand, and in 2018 moved to allow each to open two satellite dispensaries. Only three satellites have opened their doors so far.

And while some have expanded cultivation, others have struggled to do so.

“The industry as a whole would have

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Jessica Alba Revealed Her Favorite Home, Fashion, and Fitness Essentials You Can Buy on Amazon

Stefanie Keenan/Getty

It’s no secret that Jessica Alba has impeccable taste in home decor and a fashionable wardrobe, and if you’ve ever wondered how to bring her enviable style into your own space, you’re in luck. The actress just released her Amazon wish list that’s filled with modern home decor, chic workwear, and stylish fitness finds for all to see, and we couldn’t be happier. The best part? You can add them to your virtual cart for as little as $13. 

If you follow the star on Instagram and Youtube, then you know her home has a contemporary look, and unsurprisingly, the mom-of-three includes practical items on her wish list such as nonstick cookware and refillable glass spray bottles. Some of her recent YouTube videos and social media posts show her cooking tasty treats with her kids and her mom, which means these items are already being put to good use. 

RELATED: Jessica Alba Introduced Us to the Genius Product That Banishes Blisters for Good

Aside from making her home a sophisticated yet family-friendly space, The Honest Company founder also has great taste in all things fashion and beauty. No matter if she’s spending time with her kids or making an appearance on The Tonight Show with Jimmy Fallon, we typically see her wearing simple outfits with neutral tones, like jeans and a white button-down. If her effortlessly cool style inspires you, we’re happy to report that you can find affordable lookalikes on her dedicated Amazon page, and we’ve curated a list of items below that should be on your radar.

Amazon

Jessica Alba’s Favorite Workwear

Amazon

Jessica Alba’s Favorite Fitness Finds

Amazon

Jessica Alba’s Favorite Home Essentials

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Bayer to Buy Gene-Therapy Firm AskBio for Up to $4 Billion

BERLIN—

Bayer AG


BAYRY 0.16%

said Monday it would pay as much as $4 billion for U.S. biotech firm Asklepios BioPharmaceutical Inc. to strengthen the German company’s drugmaking arm, as Bayer continues to reel from its acquisition of crops giant Monsanto.

The latest deal—for which Bayer will pay $2 billion now and as much as a further $2 billion based on future success milestones—is a bet on cutting-edge gene therapy, in which a functional gene is inserted to counter the effects of a disease caused by a missing or faulty gene.

The German company’s biggest pharmaceutical acquisition since its purchase of domestic rival Schering AG in 2006 is also an attempt to tackle one of a series of challenges that has been plaguing the inventor of aspirin, especially since its 2018 acquisition of U.S.-based Monsanto.

The $63 billion Monsanto deal was meant to give the company another big, fast-growing revenue stream besides pharmaceuticals. Instead, it has saddled Bayer with a protracted legal battle over whether Monsanto’s Roundup weedkillers cause cancer—a dispute that has pummeled Bayer’s share price. Bayer says Roundup is safe.

Then, last month, Bayer shocked investors with a warning that the coronavirus pandemic would hit its agriculture business harder than expected. Bayer has also faced setbacks in settling the Roundup lawsuits for $10.9 billion.

The profit warning cast more doubt on the rationale for the Monsanto deal and its ability to boost Bayer’s profit.

At the same time, Bayer’s drug pipeline has been worrying investors. Two of the company’s bestselling drugs—blood thinner Xarelto and eye treatment Eylea—will start to lose patent protection from around 2024.

Analysts have been concerned that Bayer doesn’t have enough promising new products in its research-and-development pipeline to make up for the expected drop in sales from the blockbusters’ patent losses.

To boost its pipeline, Bayer has been looking for drug-development partnerships or deals to license drugs that are in promising stages of clinical development.

Stefan Oelrich, chief executive of Bayer’s pharmaceutical branch, said the purchase of AskBio was slightly larger than the acquisitions Bayer had been seeking in the pharmaceutical space, but added that he was convinced after the first phone call with the U.S. company’s co-founders that it would be the “perfect fit.”

“What we now have is a comprehensive pipeline,” Mr. Oelrich said in an interview. “I feel like things are really coming together on the pharma side.”

Mr. Oelrich said it was too early to predict how much in sales the AskBio treatments are likely to generate, but added that he expects the deal to help Bayer build a leading position in gene therapy. That treatment area has been gaining momentum after setbacks occurred during the first testing in humans in the 1990s, when several patients died.

Dozens of gene therapies are now undergoing clinical trials and big drug companies have been acquiring gene-therapy firms, betting on the success of those treatments in the future.

AskBio was co-founded by Richard Jude Samulski, who pioneered the use of what are known

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The budget fitness tracker to buy?





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Xiaomi Mi Band 5 review: Fitness was an integral part of our lives. Was, is the keyword here. It already seems ages when going to gym was a normal. Few months back treadmills were replaced by cycles and dumbbells started going out of stock from most e-commerce websites. And, like all other trends, these lasted less than Glen Maxwell does on the crease, especially in the IPL. If you are late to the party, then a fitness tracker is a must in the beginner’s kit. Xiaomi has launched one just in time – the Mi Band 5. Priced at Rs 2,499, the band costs marginally (Rs 200) more than the Mi Band 4. So, what do you get for 200 extra bucks and is the Mi Band 5 the budget fitness tracker to buy this festive season? Let’s find out in our review.  

Xiaomi Mi Band 5: Design 

The Mi Band 5 looks very similar to any other fitness band available in the market, both by Xiaomi or others. But who is to blame! What can you possibly do with the design of a fitness band! There is little scope to play around and Xiaomi has tried that by using a bigger and capsule-shaped display.  

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The new fitness band features a 1.1-inch AMOLED full touch display which might be a minute upgrade but makes a major difference in user experience. I have seen my mom and others struggle with the smaller displays on fitness bands. On Mi Band 5, the text and numbers are clearly readable. The brightness is good as well both for indoor and outdoor conditions. The touch control is responsive and makes the band easy to use.  

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Xiaomi has used the basic silicone straps on the Mi Band 5 which seem comfortable even during long usage. At the back, you get the heart rate sensor and charging pins. Now, this feature can leave the room divided. I personally prefer USB charging on fitness bands that don’t require you to carry an additional cable. But, Xiaomi has gone with a magnetic charger. The problem is if you lose it, there is no way of charging the tracker unless you buy a new one. 

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There are unlimited watch faces which you can change using the Mi Fit app. It helps you customize the band experience.  

Xiaomi Mi Band 5 review: Performance  

Xiaomi is offering a number of features on the Mi Band 5. It comes with 11 professional sports modes that track all indoor and outdoor activities like walking, running, Yoga, rowing machine, jump rope and more. All this data is stored in the band as well as on the app. Along with this, the Mi Band 5 also features an improved 24-hour continuous heart rate and sleep monitoring due to the improved PPG

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6 Reasons to Buy the November Issue of Men’s Health Today

Fitness is about far more than your 5K time or the visibility of your abdominal muscles. At Men’s Health, we’ve long strived to present a more thoughtful and multi-faceted view of male health and fitness.

In this issue, you’ll find all the workouts, gear reviews and insider training hacks you’ve come to expect from MH, alongside a more holistic take on health, too. With our 10-page special, Black Minds Matter, we continue our commitment to raising awareness of men’s mental health issues in various sectors of society by looking at the way in which our health services have failed black men.

We also have six feelgood workouts to boost your mental energy and pump up your well-being, plus 31 tips for fortifying your heart against life’s stresses. That, and more besides.

Zack George: Britain’s Fittest Man

Zack George reached the zenith of his sport, only to see his dream dissolve. It has been an intense and busy year for the UK’s finest CrossFitter. This is how he found triumph in adversity to become stronger than ever – and why you need to get with the programming.

Fighting for Black Minds

Black British men are four times more likely than white men to be hospitalised for poor mental health, and are less likely to seek help before they reach crisis point. The system in place to support them is broken. How do we fix it?

The Best Eco Toys in Wellness

Minimising your environmental footprint needn’t mean trading in your Nike Zooms for hemp slippers. Brands at the sharp end of performance are investing time and energy intro crafting sustainable products. Here’s our pick of the best.

Mood-Boosting Workouts

Stressed out? The body part you need to target in your next workout is the one between your ears. With a little neurological know-how, your training sessions can expel anxiety and add muscle to flagging motivation. Get a lift from these.

New Ways to Pump Up Your Heart

Almost 80% of UK adults struggle with work-related stress, while heart diseases account for more than a quarter of British deaths. That means staying young at heart isn’t just a romantic cliche – it’s a doctor’s order. Our experts have their fingers on the pulse.

Your Daily Bread

Blame bowl food for the demise of the humble sandwich. Thankfully, London’s upper crust is making your staple lunch great again – in flavour and nutritious goodness. Make a meal of it.


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Canaccord Predicts Over 100% Rally for These 3 “Strong Buy” Stocks

After passing one speed bump, is the market heading towards more bumps in the road? Following the September sell-off, there has been a surge in COVID-19 cases and limited progress on the next stimulus package. In addition, the likelihood of a Biden victory in the November elections increased.

At the same time, however, the broader market has been ramping up, with the NYSE Cumulative Advance/Decline line reaching a record high and the percentage of SPX components trading above their 10-day moving averages landing at 93% for the first time since early April.

Weighing in for Canaccord, strategist Tony Dwyer commented, “The strength of the broad market driven by the economy recovery beneficiaries has been dramatic, and while we believe the market should remain volatile (in both directions) into year end, our positive fundamental core thesis driven by excess liquidity and a synchronized global recovery suggests inevitable periods of weakness following these type ramps should be used as an opportunity to add equity exposure.”

Turning Dwyer’s outlook into concrete recommendations, Canaccord’s analysts have pinpointed three stocks that could soar in the year ahead, with over 100% upside potential forecasted for each. What’s more, after using TipRanks’ database, we found out that all three have scored enough positive reviews from the broader analyst community to earn a “Strong Buy” consensus rating.

Zynerba Pharmaceuticals (ZYNE)

Developing next-generation transdermally-delivered cannabinoid therapeutics, Zynerba Pharmaceuticals wants to help improve the lives of patients with rare and near-rare neuropsychiatric conditions. With shares changing hands for $3.65, Canaccord believes that the share price presents an attractive entry point.

This summer, ZYNE revealed that in the CONNECT-FX pivotal trial evaluating Zygel, its transdermal cannabidiol gel, in Fragile X syndrome (FXS), the therapy did not achieve statistical significance on its primary or secondary endpoints in the full analysis set, or 210 patients. That being said, it did demonstrate significance on the primary endpoint in patients with full methylation of the FMR1 gene, which was an ad-hoc pre-planned analysis, and secondary endpoints were promising.

Of the patients in the trial, 80% had full methylation, and the company estimates 60% of the 71,000 U.S. FXS patients fall into this category. To this end, ZYNE will meet with the FDA to discuss the next steps for potential approval in this indication, likely in 2H20.

Writing for Canaccord, 5-star analyst Sumant Kulkarni believes that “the key to ZYNE stock lies in the outcome of the company’s interactions with the FDA on its clinical programs for Zygel… It is always difficult to second-guess what the agency might do, but a ‘good’ outcome would involve ZYNE being potentially able to file Zygel for approval in fully-methylated FXS patients. Given there are no products approved for FXS, such an outcome, with perhaps a confirmatory trial to be run, cannot be ruled out.”

Given this result, Kulkarni argues ZYNE will now target the fully-methylated FXS patients. With the analyst seeing the targeting of this subgroup as “the best way forward for its FXS program,”

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Five Reasons Why One Should Buy a Fitness Tracker

First of all, it is very important to stay physically fit to be able to do everyday jobs effectively and efficiently during the course of our lifestyles. And to further increase our level of fitness and make our lives better, we must own a fitness tracker that keeps a track of how healthy and fit our body is at a point of time.

Besides, there are several other reasons why one should own and use a fitness tracker. This is a great tool, especially when you have lots of things to do in a limited time period. So, it's time to get a fitness tracker that suits people budget and fitness purpose. Remember that the quality and the functions of a fitness watch should decide which suits one's requirements the best.

  1. A Motivator
  2. A fitness tracker is not just a gadget, but it is more of a fitness friend and a motivator partner. The main purpose of this watch is to keep a track of a person's fitness routine and motivate him to stay fit. This device allows one to view the information regarding all the activities performed by him, so that one could know where the efforts had been spent all the day long. This information would later help one to set smarter objectives.

  3. Fitness Objectives
  4. A fitness watch is a help for one to set future goals. By offering a visual impression of the improvements and progress one makes, this device allows one to meet goals smartly and set better goals based on what one has already accomplished. But before setting up better goals, one should first note down the purpose of the tracker, whether it is losing weight, building body, tracking sleep or serving any other purpose.

  5. Monitoring the Heart Rate
  6. Another benefit of this device is that it keeps monitoring the heart rate, whether one is working out or taking rest. This would help one single out the activities that overload during exercises. It's a great way of monitoring heart rate.

  7. Tracking Sleep
  8. A fitness watch has a role in every activity that one performs, be it exercising or even sleeping. Getting good quality sleep is also a very important factor in one's lifestyle. Moreover it also optimizes the rate of success in one's fitness schedule. One's body must get enough sleep to make up for all the daily exhaustion and proper tissue repairing and building.

  9. Swimming and Diving
  10. Regular swimmers must get a water proof fitness tracker. With this device, they can get more out of their swimming program as they continuously receive the data of their fitness schedule even in the water. In addition to this, one can also get detailed information regarding their swimming strokes and pace.

Fitness is certainly important; However it is more important to keep a track of the fitness. This would help one make better goals and increase efficiency. So, one should definitely buy a fitness tracker which makes it possible for to know whether he / she is …

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Money Can’t Buy Fitness, You Gotta Earn It

It’s long been said that money can’t buy everything and most will agree if they are truly being honest throwing silliness aside. Money can’t buy you true love. Money can’t buy back your youth or bring back loved ones that have passed on. And additionally, money can’t buy fitness no matter how much you shell out of your pocket.

To make that point clear, all the money in the world cannot automatically create that perfect physique regardless of how much you are willing to pay. Sure money can pay for a private gym membership or even allow you to build your own gym in your backyard. Money will also allow you to hire a 24 hour a day personal trainer along with a chef to be at your beckoning call whenever you need a healthy meal prepared.

Money can also pay for weight reduction surgeries or “tummy tucks” which can give the appearance of a reduction in weight. However even in this case the person is not fit, they just have less fat – completely different case.

However even with these things that money can potentially buy, they will not magically get you fit. The sweat and effort will still have to come from you and that is something money cannot buy.

You have to earn fitness and that is the beauty of it. No matter how rich or poor a person is, fitness is something that judges not on how financially well off you are.

If you’ve ever seen Brad Pitt in the movie Troy, Henry Cavill in Man of Steel, or Chris Hemsworth as Thor in the Avengers, these famous actors had to workout constantly and eat nutritiously for a number of months in order to develop the physique needed for their roles.

Don’t believe me? YouTube or Google their workout and nutritional regiments and you’ll see what they had to do in order to get in shape. Even these rich, famous actors had to put in the time to get fit.

Once you come to terms with this fact, you will see that money cannot buy fitness, it is something that has to be earned. If it helps motivate you, just maintain the mantra “If Brad had to do it, I can do it!”

Take it upon your shoulders and commit yourself wholeheartedly to a fitness plan. Be willing to exercise 4-6 days per week for a certain amount of time even if it’s just for 20-30 minutes when beginning.

Everyone has to start somewhere, but the point of the matter is to start.

Naturally this habit will take some getting used to, but the better you stick with your fitness plan, the quicker this will truly become an important part of your life. Once you adhere to your workout routine for a certain amount of time, you will realize that money really can’t buy fitness. You’ll only get fit through hard work and determination.

Don’t forget about the importance of tying healthy nutrition into your fitness …

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