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Biotech Scandal: Former CytoDyn CEO Accused of Fraud and Insider Trading

In a significant legal development that has sent shockwaves through the biotech industry, federal prosecutors have brought charges against key executives involved in the clinical development of an experimental drug. The case underscores the importance of transparency and integrity in the pharmaceutical sector, where investors and patients alike rely on accurate data to assess the viability of potential treatments.

The U.S. Department of Justice indicted former CytoDyn Inc. Chief Executive Officer Nader Z. Pourhassan and the chief executive officer of Amarex Clinical Research on multiple counts of fraud.

The DOJ said Pourhassan, who was terminated by Washington-based CytoDyn earlier this year, and Kazem Kazempour conspired to defraud investors by misrepresenting data related to the clinical development of experimental monoclonal antibody leronlimab.

Kazempour was head of Amarex, a Maryland-based contract research organization that managed CytoDyn’s clinical trials. He also served on CytoDyn’s Disclosure Committee, which was responsible for approving the company’s filings with the U.S. Securities and Exchange Commission.

The federal indictment, unsealed Tuesday, alleged the two men engaged in “false and misleading representations and material omissions” regarding the development of leronlimab in order to artificially inflate the price of CytoDyn’s stock.

Leronlimab is being developed for both HIV and COVID-19.

Leronlimab is an investigational humanized IgG4 monoclonal antibody that is designed to bind to C-C chemokine receptor type 5. Development of the experimental drug has been stymied by clinical holds.

The DOJ said Pourhassan and Kazempour made “false and misleading representations” regarding the development timelines related to the Biologics License Application for leronlimab.

According to the government, after CytoDyn missed multiple publicized development timelines, Pourhassan pushed for Kazempour to file the BLA, even if it was incomplete.

Even though a rejection of the BLA was almost assured, the government alleged the men filed for approval to meet those announced timelines and influence stock prices.

Following the regulatory filing, CytoDyn publicly stated it had filed a completed BLA.

After the announcement was made and stock prices increased, Pourhassan sold millions of dollars worth of CytoDyn stock, the government said.

This isn’t the first time Pourhassan has been associated with misleading clinical data.

In 2022, while still helming CytoDyn, Pourhassan and the company were the focus of an FDA public scolding. The regulatory agency accused CytoDyn of misrepresenting clinical trial results assessing leronlimab as a potential treatment for COVID-19.

CytoDyn pushed a positive narrative for the drug’s efficacy based on a small subset of patients on mechanical ventilation. The company argued the drug generated a 24% decrease in all-cause mortality and a six-day reduction in hospitalization.

The FDA rejected the data. The agency said no amount of spin from CytoDyn could show a statistical significance.

In October, CytoDyn pulled its BLA for leronlimab as a potential treatment for COVID-19 based on concerns related to the clinical trials conducted by Amarex Clinical Research LLC. Company Pres. Cyrus Arman, tapped for the role in July, announced at the time that CytoDyn is seeking damages from the CRO due to a breach of the Master Services Agreement.

While leronlimab’s development is marred, when the company pulled the BLA, Arman noted the monoclonal antibody is showing promise in other indications, including oncology and non-alcoholic steatohepatitis (NASH).

He said CytoDyn plans to re-enter leronlimab into the clinic in those indications.

Pourhassan and Kazempour are each charged with one count of conspiracy to commit securities fraud and wire fraud.

They are also charged with three counts of securities fraud, and two counts of wire fraud related to the HIV BLA scheme.

Pourhassan is also charged with an additional count of securities fraud, an additional count of wire fraud related to the COVID-19 scheme, and three counts of insider trading. Kazempour is separately charged with one count of making false statements to federal law enforcement agents.

If convicted, Pourhassan and Kazempour each face a maximum penalty of 20 years in prison on each securities fraud and wire fraud count. They also face five years in prison on the conspiracy count. Kazempour also faces a maximum penalty of five years in prison on the false statements count, according to the government.

The case against Pourhassan and Kazempour serves as a stark reminder of the legal and ethical responsibilities of executives in the biotech industry. While the promise of breakthrough treatments can drive excitement and investment, the manipulation of clinical data not only misleads stakeholders but can also hinder legitimate scientific progress. The outcome of this case will likely set a precedent for regulatory oversight and corporate accountability in the years to come.

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Nicholas Zubrick: Why Kids don’t like going to School

Nicholas Zubrick is explaining you the top reasons Why Kids Don’t like going to School. Almost everybody in life has attended school once in our lifetime & No matter how much you miss your school days or to be precisely said your school friends, you can never really forget those miserable boring classes, horrifying punishments or bullying. Nicholas Zubrick Port Authority advises that as parents you must motivate your children. Nicholas Zubrick Port authority believes we are kinda of a stuck into a Love-Hate Relationship with our school.

1: Regularity

Well this is one of the main reason School is very much different from college where the teachers doesn’t care much about the strength of the class and never call out for attendance. Unfortunately school is somewhere where kids are forced to go whether they like to visit school or not. They’ve got no choice. Regularity has to be maintained. Also the parents are very strict with it.

2: Boring Lessons

Ah who can forget those boring lessons by teacher you hate. Well, the typical scenario is the teacher jabbering standing on the rostrum while the students daydreaming about another fantasy world in imagination is considered to be a typical classroom scenario & not to forget about the Never-ending lectures of geography and history. Who can put with it? But unfortunately every kid has to deal with thisthere is no other option.

3: Never-Ending Punishments

The never ending punishments for small & stupid reasons everybody hates this part of school. In School things like talking in the class are treated like major crimes and you’re punished very severely for them. No matter how much obedient student you are & try to follow all the rules of school, you end breaking one rule and you will get punished on daily basis.

4: Parent Teacher Meeting

The worst part of schools life according to every students. This is the day that acts as a judgement day when their parents meet up with the teachers & discuss their result. All your negative points are just thrown onto your parents face and there you are standing dumbstruck fearing uttering a single word.

5: Surprise Tests

Ah surprise tests only surprise you don’t like in your life. Well School is the only place where in the name of surprises you don’t get expensive gifts instead you get tests. You just happily enter the class and the suddenly you’re shocked to hear “I’ll be taking a surprise test today” this from your teacher. Not knowing what to write in it kids simply copy answers from one another or a big zero.

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Nicholas Zubrick: Safety Rules You Must Follow While Driving

Nicholas Zubrick is explaining you details about the top five Safety Rules You Must Follow While Driving. There is a tremendous increase in the number of cars which has made our life much more convenient. Nicholas Zubrick Port Authority advises everyone to Follow Traffic Rules for the safety of everyone on the road.

1: Never Drink and Drive

This is the golden rule of driving. You must never drive if you are drunk as alcohol causes a number of impairments that lead to accidents. Even at very low alcohol levels in blood, it reduces the reaction time, lowers inhibitions and lowers the guessing power. At very higher levels of alcohol, it even causes blurred vision and loss of consciousness.

2: Always Wear Your Seat Belt

You must always wear the seat belt it is the most essential thing to do for a car driver. A seat belt prevents you from being thrown around the inside of a crashing vehicle or through the windshield and any other misfortune and thus saves your life. According to a report, wearing a seat belt reduces the risk of injury by 45% to 50%.

3: Follow Three Second Rule – Don’t Follow Too Closely

You must follow three second rule & must keep a safe distance between you and the car ahead. Because if the other vehicle suddenly applies the breaks, then the driver behind needs atleast enough time to react in that situation & it is difficult to estimate the recommended distance while driving, so most experts recommend a “three-second rule”.

4: Always Avoid the Distractions

While driving you must avoid all kind of distractions like taking on mobiles, eating food etc. due to these distractions the drivers are not able to give their attention to the road and their reaction time is affected & this causes severe damage to the life & property as well. Many studies have shown that these distractions can lead to severe accidents & even death.

5: Never Run a Red Signal

Never run a red signal as running a red light is one of the most common reasons for road accidents. When you try to cross a red light, you take a big risk that another car may ram you right into your path. Moreover, there are chances of pedestrian step out into the crosswalk. All these things may lead to serious accidents & no one will be at fault except you.

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Nicholas Zubrick: Top Five Healthy Snacks to Eat

Nicholas Zubrick is explaining you details about the top five Healthy Snacks you can eat. A snack is a small portion of food, as contrasted with a regular meal. Traditionally snacks were prepared from ingredients commonly available in the home, often leftovers, sandwiches made from cold cuts, nuts, fruit etc. Beverages are not considered real snacks, especially coffee. Nicholas Zubrick Port Authority advises you to healthy snacks not the packed ones.

1: Almonds and Apricots

Almonds are high in protein and fibre, as well as being low-GI is a good source of magnesium, and rich in vitamin E. Dried apricots, on the other hand, are rich in carotenes, which may lower the risk of cancers of the throat and lungs and provide you with potassium, iron, calcium, silicon, phosphorus, and vitamin C.

2: Yogurt and Honey

Yogurt is low in fat, high in calcium and good for your gut. A recent study also found that people who got their calcium from yogurt rather than other dairy sources lost more weight around the tummy area. Honey has been shown to increase the blood’s level of protective antioxidants, and may also be a useful diet addition for people with high cholesterol.

3: Apples and Pears

Apples are high in pectin, a soluble fibre contain quercetin — an antioxidant that can reduce damage caused by cholesterol. They have a high water content, which will help to keep your thirst satiated. Apples are also a good source of vitamin C. Pears are high in potassium and are also a good source of fibre and vitamin C.

4: Dark Chocolate

Dark chocolates containing at least 70 per cent cocoa solids are a good source of antioxidants, particularly flavonoids, which are the type that are found in green tea and red wine. And while chocolate is high in fat, it consists of saturated fats including stearic and palmitic acid, a monounsaturated fat that is also found in olive oil.

5: Peanut butter on Crisp breads

This is the perfect combination of protein, fat, carbohydrate, and lots of fibre. While peanut butter is high in fat, it is mostly the unsaturated fats which are not harmful. Peanuts are a great source of the antioxidant vitamin E. Peanut butter is also rich in protein, so it is a good option especially for vegetarians and a good source of magnesium.

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Nicholas Zubrick: Why Sleep is Important

Nicholas Zubrick is explaining you about the top five reasons to take the proper sleep. All of us know the very common phrase, “Early to bed, early to rise makes a person Healthy, wealthy and wise.” The sleeping positions and timings matter a lot in everyone’s life, scientifically. Nicholas Zubrick Port Authority believes that the Quality of sleep matters, not the quantity. The importance of sleep is still not known to many of us even today. People consider sleep inferior to their work, which shouldn’t happen. We should consider our sleeping hours as a serious matter of health. Nicholas Zubrick Port Authority advises you to take proper sleep of 8 hrs.

1: Brain Power

The activity to sleep not only makes you get relaxed and recharge, but it also helps in enhancement of your brain power that is your memory and concentration. Yeah, this is the top most reason as to why sleep is so important. We all want ourselves and also our kids to be healthy and brainy.

2: Life Span

We all wish that we should be immortal or undead like the vampires in tales and movies. But we can’t. But yes, why do we decrease our life span, by not sleeping? Inadequate sleep decreases our life span. This is a very great reason as to prove you that why sleep is so important in our life

3: Immunity

A best part of our body is that it protects us internally by immunity system present in it. We don’t get many diseases like cold, cough etc. if our immune system is great, but do you know that the immunity system can be affected if you don’t take adequate sleep? Hence, sleep more to boost up your immunity power.

4: Revitalize

Revitalizing our body every day is very important to gain back our physical as well as mental strength to work more and more. As I told you above, you have fresh mornings when you take proper sleep. Also the main process that makes you feel fresh and enthusiastic for next day’s work is revitalization.

5: Fresh Mornings

We all want our mornings to be fresh and beautiful. But we enjoy this only on our weekends and holidays. But, now you can make your every day’s morning fresh You will always boost up on the thought of making your every morning, a fresh morning. Thus, Sleep is important factor in making your mornings go fresh

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Nicholas Zubrick Explaining About Most Scenic Routes of World

Nicholas Zubrick is explaining about the top five Most Scenic Routes of World. Nicholas Zubrick Port Authority believes you can take a relaxed break from your hectic schedule by driving through these scenic spots. The following are some of the scenic drives around the world which can surely leave you very energised and relaxed. Nicholas Zubrick Port Authority believes these are world’s most beautiful roads and you must visit theme once in your life.

1: Western Desert, Egypt

While you go from Cairo to Egypt you can see this scenic place. Travel kilometres upon kilometres of golden dunes. See the stunning rock formations and rest at precious oases- take a safari into the Western Desert. You can also see some of the beautiful oases such as Dhakla, Kharga and Siwa while traveling.

2: The Seward Highway

You can see the superb beauty of Alaska as you go along the Seward Highway. You can come across beautiful waterfalls, lush vegetation comprising rare flora and fauna as you go along this highway. You can also see sheep and mountain goats along this path. You can enjoy fishing and camping on this place.

3: Transfagarasan Road, Romania

This road is not only famous for its vampire history but is full of verdant vegetation and lofty mountains which will make you have a fun filled holiday in this scenic spot. The road is quite peaceful road and is a great way to see snow in August, breath fresh air and escape from the dusty polluted cities.

4: Icefields Parkway, Alberta, Canada

The beauty of the Ice fields parkway has to be seen to be believed. White snow, colossal mountains and green vegetation make the route all the more captivating. You can also come across amazing flora and fauna comprising of bears, moose, elks and the blue waters and waterfalls will leave you mesmerized.

5: Alsace Wine Route, France

This route is replete with rustic sights such as the Rhenan plains, the majestic Vosges Mountains, the beautiful villages with their traditional culture and customs and lots more. Taking a drive along this path can leave you everlasting memories of this place.

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Top Five Amazing Geological Oddities in the World by Nicholas Zubrick

Nicholas Zubrick is explaining about five amazing geological oddities in world. Nicholas Zubrick Port Authority believes these are some of the most awe-inspiring and amazing geological oddities found around the world. Nicholas Zubrick Port Authority believes these fantastic spots, most of which are purely natural phenomena, are all quite certainly worth a visit. Nicholas Zubrick believes you must visit these amazing geological oddities once in lifetime.

1: United States

Death Valley, California, is a place where rocks can be found to move on their own. Surrounding the racetrack are pebbles and boulders strewn all about. Strangely, some of the rocks really do move, though others stay completely still.

2: The Richat Structure or “Eye of the Sahara”

This impressive sight can be seen in Mauritania, at the south-western tip of the Sahara desert. This land formation is so large, with a diameter of 30 miles, that it can in fact be seen from outer space. Originally, this structure was believed to have been formed by a meteorite impact.

3: The Driest Place on Earth, the Atacama Desert

The Atacama Desert receives less than 1mm of rain per year and is considered to be the driest place on the planet. The desert is the product of the Andes rain-shadow. The trade winds which move east along South America begin to lose all moisture when they hit the steep slopes of the Andes Mountains.

4: The Naica Mine, Cave of Crystals, Mexico

These caves, found in a mine in Chihuahua Mexico, have some of the biggest crystals ever discovered and are a spectacular sight. Made of Gypsum, the crystals were allowed to grow unimpeded and hence are worth a mention among the world’s top-most geological oddities.

5: The Curtain of Fire, Hawaii

During the initial stage of the Puu Oo eruption in January, 1983, these amazing lava fountains erupted first. They later formed a wall of magma 100-160 feet high along the Eastern Rift of Mount Kilauea following a fissure.