New York Attorney General Letitia James sent a letter to the Cornerstone Church in Batavia warning that she could take legal action if “extremist” rhetoric at a pro-Trump event the church planned to host spurred violence or illegal actions. “You are therefore instructed to take all necessary steps to ensure that the event complies fully with the requirements of New York’s civil rights laws and all other applicable state and federal statutes,” James wrote. She warned of $5,000 fines for violating those laws. Pastor Paul Doyle said he believed the letter was an attempt to intimidate the church and the event’s organizers.
Jerk From Home: Pandemic Has Fueled A Rise In UK Porn Addicts
As former CNN personality Jeffrey Toobin can tell you, working from home can pose its own unique set of ‘challenges’ – including turning casual porn watchers into total addicts who wank away the day.
In the United Kingdom, the number of Britons seeking medical help for the issue has almost doubled during the pandemic, when working from home became mainstream, according to the Daily Mail.
The Laurel Centre in London, the largest sex and porn addiction clinic in Britain, says it is now treating some remote workers who watch up to 14 hours of porn a day.
Dr Paula Hall, the centre’s clinical director, said WFH meant people are now spending more time than ever alone in front of their computers.
“It means you’ve got more opportunity, you don’t have to wait until you get home at night, you can be more impulsive during the day,” according to Hall, who noted that the London-based center saw around 750 porn addicts during the first six months of 2022 alone – vs. 950 for all of 2019.
Therapists working for the center also spend around 600 hours a month counseling people with porn addictions vs. just 360 hours per month in 2019, while Sex Addicts Anonymous UK told the Mail that lockdown and pandemic stress took a toll on mental health, driving people to porn websites.
“Porn addiction is a shame-based illness. We use compulsive sexual behaviour to escape from and block difficult feelings,” said one spokesman. “It’s easy to see why; sex is powerful and all consuming and unlike alcohol or narcotics, we don’t have to visit the office or see our dealer.”
“We face a public health crisis with toxic pornography available at no cost to anyone, which is especially worrying for our young people.“
According to Dr. Hall, working from home allows people to act on impulses without the fear of colleagues seeing them (for the most part).
There were an estimated 1.7 million people who said that they work mainly from home in 2019, according to the Office for National Statistics (ONS), which this represents about 5 per cent of the total workforce.
This surged to almost half (46.6 per cent) in April 2020 during the first Covid lockdown, with about 13million mainly working from home.
While the share of people working predominantly from home has dropped since the peak of the pandemic, hybrid working has become a mainstay.
The most recent ONS data suggests 9.9million people now mainly work from home. -Daily Mail
“If you’re regularly viewing pornography for longer than two hours it’s probably not about sexual arousal. It’s probably about escape,” said Dr. Hall, adding “It’s a bit like making yourself breakfast and staring at it for two hours, if you’re hungry, you’re going to eat it, not going to stare at it.”
“Addiction is a sign of a life that is unhappy and not being well managed.”
New York Attorney General Letitia James sent a letter to the Cornerstone Church in Batavia warning that she could take legal action if “extremist” rhetoric at a pro-Trump event the church planned to host spurred violence or illegal actions. “You are therefore instructed to take all necessary steps to ensure that the event complies fully with the requirements of New York’s civil rights laws and all other applicable state and federal statutes,” James wrote. She warned of $5,000 fines for violating those laws. Pastor Paul Doyle said he believed the letter was an attempt to intimidate the church and the event’s organizers.
By Heather Burke, Bloomberg markets live commentator and reporter
With the summer’s European stock rally expected to abate, political risk can add to Italian stocks’ underperformance.
The FTSE MIB fell 2% on Friday, compared to 0.8% for the Stoxx 600, and continues lagging the benchmark today. The country’s right-wing coalition led by Giorgia Meloni’s Brothers of Italy party is nearing a landmark level of support.
A strong election result by Meloni’s bloc could see it garner enough votes in parliament to reach a two-thirds majority. That could allow the right to push through changes to the constitution, possibly including enhanced powers for the prime minister’s office or direct election of the country’s president. Italian bonds also fell for four days.
Italian stocks are faring slightly better than the Stoxx 600 this month but the FTSE MIB is the worst-performing major Western European benchmark year-to-date. Economic and energy crises and fragmentation headwinds have buffeted the stocks. Political chaos has contributed to the underperformance, with Mario Draghi’s resignation spurring a snap election next month.
Banks are the biggest industry in the FTSE MIB at almost 20% and a gauge of Italian lenders has lagged the FTSE MIB and Stoxx 600 Banks index last week and so far this year. Banks are tied to the moves in BTPs and a symbol of political risk. Earlier this month Bloomberg Intelligence noted the FTSE MIB’s “fundamental resilience” faces greater geopolitical uncertainty — on a widening BTP-Bund spread and potential European economic slowdown.
Italian 12-month forward EPS growth has slightly outperformed the Stoxx 600 so far this year, and the gauge remains cheap historically on an absolute basis and compared to the Stoxx 600. But that’s not enough to garner sufficient investor interest. Italian and German stocks remained the least preferred in the most recent Bank of America European fund manager survey.
Zelensky Says Russia’s Mass Trial Of Captured Mariupol Fighters Will Make Peace Talks “Impossible”
It’s obvious at this point that Ukraine’s military is seeking to expand strikes inside Russian-controlled Crimea, which this month has become an unprecedented first following a brutal, grinding more than half-year of war. Zelensky has called for its “liberation” – but if this weren’t enough to ensure that the conflict will continue to burn for at least the near to medium-term future (the war is possibly set to endure for years, according to the predictions of some US defense officials), Zelensky’s latest remarks on Monday suggest that any potential ceasefire negotiations aren’t even so much as anywhere on the horizon.
Zelensky called the idea of negotiations with Moscow “impossible” if Russia moves forward with plans for a mass trial of captured Mariupol defenders. “If this despicable show trial takes place, if our people are brought into this scenery in violation of all agreements, all international rules, if there is abuse … this will be the line beyond which any negotiations are impossible,” Zelensky said Monday.
“Russia will cut itself off from the negotiations,” he stressed. “There will be no more conversations. Our state has said everything.” Russia too has of late been expressing a similar position of being closed to talks, blaming Kiev and its Western backers, and President Putin is expected to dig in his heals further especially after the recent Crimea attacks as well as the car-bombing of Alexander Dugin’s daughter Darya on Saturday night.
In the comments he confirmed he is in ongoing conversation with United Nations Secretary-General António Guterres, French President Emmanuel Macron and Turkish President Recep Tayyip Erdoğan over what Ukraine is dismissing as a show trial, saying that he expects the UN to issue clear condemnation.
“Everyone understands everything,” Zelensky said. “They understand what the occupiers are doing and what it threatens,” he added of international powers. “And they understand that Ukraine will not tolerate this. It will not tolerate tormenting of people about whom only one thing can be said: they are heroes of their homeland, they defended the freedom of their people from invaders on their land.”
Russian foreign ministry officials have meanwhile complained separately that it’s the UN itself largely to blame for lack of any diplomatic process towards a negotiated settlement to the war:
Gennady Gatilov, Russia’s permanent representative to the UN in Geneva, told the Financial Times that the UN should be playing a bigger role in attempts to end the conflict and accused the US and other Nato countries of pressing Ukraine to walk away from negotiations.
There would be no direct talks between Putin and Ukraine’s president Volodymyr Zelenskyy, he said. “Now, I do not see any possibility for diplomatic contacts,” Gatilov said. “And the more the conflict goes on, the more difficult it will be to have a diplomatic solution.”
As for the hundreds of Ukrainian fighters who spent literally months holed up in the cavernous Azovstal steal plant while under siege by numerically superior Russian forces, Kremlin authorities have said they mostly make up the neo-Nazi Azov battalion. Earlier Russian media reports additionally alleged that some foreign fighters may have been in their midst as well.
Ukraine officials and pundits are livid over the planned optics of the trial…
Russian puppets plan to hold a show trial of the captured defenders of Azovstal in Mariupol on August 24, Ukraine’s Independence Day. Killing of Dugin’s daughter will be used to justify the trial and further Russian war crimes including missile attacks. #russiaisaterrorisstatepic.twitter.com/u5D757mtWR
Already, some foreign fighters, including UK nationals, were in months past sentenced to death by a local pro-Russian Donetsk court. It’s entirely possible and even likely that the captured Azov members will be issued the same sentence. Without doubt, Moscow will seek to “send a message” with this trial. Russian forces have accused Azov battalion of being genocidal and of committing ‘terrorism’ against civilians.
The trial is also sure to capture global headlines and likely elicit UN condemnation, also given that – as The Hill reports – “Ukraine’s military intelligence arm warned on Friday in a Telegram post that Russia has been remodeling the Mariupol Chamber Philharmonic and installing iron cages in the building for a trial on Wednesday, which marks Ukraine’s independence day and six months since the war began.”
Not doing their Bond villain reputation status any favors, the World Economic Forum published an article suggesting it would be a “solid, rational” move for children to be implanted with microchips.
Yes, really.
The idea is promoted in a blog post on the Davos elite’s website which discusses the future of augmented reality and an “augmented society.”
“As scary as chip implants may sound, they form part of a natural evolution that wearables once underwent. Hearing aids or glasses no longer carry a stigma,” the article argues, perhaps forgetting that glasses and hearing aids aren’t embedded inside the body, nor can they be controlled by outside forces.
“They are accessories and are even considered a fashion item. Likewise, implants will evolve into a commodity,” writes scientist Kathleen Philips, suggesting that mainstream culture and influencers will be tapped to promote implantable chips as a trendy status symbol.
The article pushes the notion that augmented humans are inevitable and that global elites need to establish a power monopoly over the technology in order to “ethically” regulate it.
The technology is in need of “the right support, vision, and audacity,” which of course will be provided by your technocratic overlords, the same people who are desperately trying to censor the Internet so they can’t be criticized.
“The augmenting technology will help in all stages of life: children in a learning environment, professionals at work and ambitious senior citizens. There are many possibilities,” writes Philips.
“Should you implant a tracking chip in your child?” asks the scientist, adding, “There are solid, rational reasons for it, like safety.”
As we previously highlighted, World Economic Forum chief Klaus Schwab wrote in his book ‘The Great Reset’ that the fourth industrial revolution would “lead to a fusion of our physical, digital and biological identity,” which he clarifies is implantable microchips that can read your thoughts.
During this year’s Davos meeting of global elitists, Pfizer CEO Albert Bourla explained to Schwab how soon there would be “ingestible pills” – a pill with a tiny microchip chip that would send a wireless signal to relevant authorities when the pharmaceutical has been consumed.
Pfizer CEO Albert Bourla explains Pfizer’s new tech to Davos crowd: “ingestible pills” – a pill with a tiny chip that send a wireless signal to relevant authorities when the pharmaceutical has been digested. “Imagine the compliance,” he says pic.twitter.com/uYapKJGDJx
“It wasn’t that long ago that those speculating on a future where this is happening would get dismissed as conspiracy theorists, but now the world elites’ most vocal outlet is predicting that chip implants will eventually become just a commodity,” writes Didi Rankovic.
As we previously reported, an Australian primary school predicted “microchips in student’s brains” within 10 years before subsequently deleting the newsletter that contained the creepy prophecy.
But this time, sanctuary cities, the bane of immigration law enforcement advocates, have a different spin. Since five-time deported illegal immigrant Jose Inez Garcia-Zarate murdered Kate Steinle in July 2015 on Pier 14 in San Francisco, state and city governments have persisted in welcoming illegal aliens and protecting them from Immigration and Customs Enforcement. San Francisco is a sanctuary city in the sanctuary state of California.
Despite a federal immigration detention request to hold Garcia-Zarate so immigration officials could take him into custody, San Francisco authorities freed the seven-time convicted felon just three months before he killed Steinle. Eventually, Garcia-Zarate was acquitted and sentenced to time served on an illegal firearms possession charge.
Between January 2014 and September 2015, the Center for Immigration Studies reported that sanctuary jurisdictions rejected 17,000 ICE detainer requests – 17,000 individuals who should have been deported but remained to potentially pose criminal risk to U.S. citizens. Claiming that migrants are fleeing poverty and persecution, local leaders have been willing to spend their constituents’ taxpayer dollars on affirmative benefits for the newly arrived illegal immigrants.
Suddenly, however, with President Biden and Department of Homeland Security Secretary Alejandro Mayorkas opening the Southwest border to foreign nationals from 150 countries and clandestinely flying them to faraway cities, attitudes are less welcoming. New York Mayor Eric Adams said that busing migrants from Texas to mid-town Manhattan, as Gov. Gregg Abbott has done, is “cruel.” About 4,000 unlawfully present migrants have entered New York’s shelter facilities since May, an ”unprecedented surge,” said Adams, who has unsuccessfully called on the federal government to intervene.
Washington, D.C. Mayor Muriel Bowser has made the same complaints as Adams, labeling the migrant flood “critical,” issuing identical rejected pleas for federal intervention. Since April, Gov. Abbott has sent more than 6,800 illegal immigrants to Washington. Bowser has begged for the National Guard to intervene “to help prevent a prolonged humanitarian crisis in our nation’s capital resulting from the daily arrival of migrants in need of assistance.” McAllen, Texas, Mayor Javier Villalobos mocked Adams and Bowser. Villalobos said: “The city of McAllen was able to deal with thousands of immigrants a day; I think they can handle a few hundred.”
Adams and Bowser should have known that pleading with the feds, especially Mayorkas, would be futile. At the January U.S. Conference of Mayors, Mayorkas tried to sell the assembled mayors on his new, mostly gutted ICE. But the attendees wanted to hear about border enforcement, a subject Mayorkas studiously avoided.
While it may be overly optimistic to hope for a change now that prominent Democratic mayors are experiencing first-hand the fiscal burden and public safety risks that sanctuary policies create, a shift is in the wind.
The mere existence of sanctuary cities is illegal. Local laws that protect illegal immigrants prevent routine cooperation among municipal, state and federal law enforcement agencies. President Obama’s Attorney General Loretta Lynch realized the importance of keeping law enforcement apprised about any individual’s immigration status. Lynch warned sanctuary cities that they would not receive Justice Department funding in the 2017 fiscal year if they did not comply with 8 USC Section 1373, which prohibits any agency from restraining “in any way” the exchange of information among federal, state and local agencies regarding foreign nationals’ immigration status. Despite saber-rattling from Lynch, and then-Attorney General Jeff Sessions, funding continued.
With millions of border crossers already released into the U.S. interior, and millions more anticipated during Biden’s remaining two and a half years in office, sanctuary cities will come under increasing pressure to provide for their unlawfully present alien residents, an untenable situation for the already underfunded, overcrowded municipalities.
US Border Agents Seize 1.6 Million Fentanyl Pills In Big-Rig, Destined For US Cities
Customs and Border Protection agents in Arizona seized a mind-numbing 1.57 million fentanyl pills and 114 pounds of cocaine hidden within secret compartments of a tractor-trailer.
Port Director Michael W. Humphries tweeted a huge cache of drugs was discovered in an “18-Wheeler trailer floor compartment” on Saturday. The vehicle was attempting to cross into Arizona from Mexico at the Nogales Port of Entry when CBP agents stopped it for inspection.
This massive seizure disrupted the flow of dangerous amounts of fentanyl across US cities and likely saved many lives. There was no word if this seizure was a record-breaking bust. Earlier this summer, we noted that “unprecedented levels of fentanyl” are entering the country via the southern border.
Last week, Humphries tweeted, “colored fentanyl pills with the appearance of candy” were seized at the port of entry. The candy-like fentanyl pills are very troubling as children could mistake the drugs for candy during Halloween.
8/17 CBP officers #Nogales POE seized over 15,000 fentanyl pills strapped to a person’s legs. Second consecutive day colored fentanyl pills with the appearance of candy seized .This could be the start of a trend with Transnational Criminal Organizations targeting younger users. pic.twitter.com/y5KT5Zveop
— Port Director Michael W. Humphries (@CBPPortDirNOG) August 18, 2022
In another tweet, he noted that “250,000 fentanyl pills (some of which were different colors, similar to the appearance of candy)” were seized.
.@CBP officers at the Port of Nogales AZ seized a vehicle containing:
Over 250,000 fentanyl pills (some of which were different colors, similar to the appearance of candy)
11 LBS heroin
10 LBS meth
— Port Director Michael W. Humphries (@CBPPortDirNOG) August 17, 2022
The seizures come as deaths from synthetic opioids are skyrocketing, up more than 56% from 2019 to 2020, according to the Centers for Disease Control and Prevention.
Besides copious amounts of fentanyl pills being seized at one land port, a tractor-trailer filled with 150 migrants was stopped in Texas.
Mexican authorities, with the assistance of Del Rio Sector Border Patrol, stopped an 18 wheeler truck with 150 migrants crammed inside being smuggled to the U.S. border. All survived.
Incredibly dangerous w/ the summer heat. 53 migrants died in a trailer in San Antonio in June. pic.twitter.com/WUjLOCALXv
The flow of drugs and migrants across the border into the US is a tremendous problem that the Biden administration chooses to ignore.
Democrat mayors in New York City and Washington, DC have recently awakened to the reality of a border crisis after Texas Governor Greg Abbott shipped a caravan of migrants via busses to their respective metro areas.
President Biden’s ongoing humanitarian and national security crisis at the border worsens by the week, and no one in his administration has yet to take responsibility for the nightmare it has created.
Aduhelm is the brand name under which the Alzheimer’s drug Aducanumab is marketed. It is developed by the U.S. company Biogen. The drug is to be administered as an intra-venous infusion every four weeks.
The Food and Drug Administration (FDA) approved Aducanumab in June 2021, making it the first Alzheimer’s disease medication approved by the FDA since 2003. It is also the first ever approved Alzheimer’s drug targeting the presence of amyloid beta (a type of protein) plaques in the brain.
However, almost everything about this drug is controversial, from the theory on which the drug is developed, to its clinical trials data, to the FDA approval itself. This article aims to distill the complicated information down to a few points, which might help patients make more informed decisions.
Key Dates Surrounding the FDA Approval of Aducanumab
July 2020: Biogen completes submission of aducanumab data (from previously discontinued clinical trials) to FDA.
November 2020: FDA external advisory committee rejects aducanumab because the data failed to prove the drug’s efficacy in reducing cognitive decline in Alzheimer’s patients.
June 2021: FDA grants accelerated approval for aducanumab for patients of all stages of Alzheimer’s disease, on the condition that Biogen conducts post-approval trials (phase 4 trials) to verify the efficacy of the drug.
Biogen’s Troubled Clinical Trials
Biogen started two practically identical phase 3 clinical trials in August 2015 to evaluate the safety and efficacy of different aducanumab doses in patients with early stage Alzheimer’s disease.
But in March 2019, Biogen terminated the trials after an interim futility analysis, run by an independent data-monitoring committee, predicted that the trials were unlikely to meet their primary outcomes.
Only seven months later, in a surprise press release, Biogen revoked its earlier decision citing that a new analysis with another three months of data produced positive results. The company stated, “The positive results of this new analysis were driven primarily by greater exposure to high dose aducanumab in the larger dataset as compared to data available at the time of the futility analysis.” In the same press release, Biogen announced its plan to apply for FDA approval, “based on discussions with the FDA, the Company plans to submit a Biologics License Application in early 2020.”
FDA Granted Approval Despite Experts’ Disapproval
It is routine operation for FDA to invite subject matter experts, who are “outside the government with minimal conflicts of interest” to form external advisory committees and give non-binding recommendations for FDA’s consideration. In November 2020, the Peripheral and Central Nervous System Drugs Advisory Committee voted almost unanimously against the approval of Aducanumab. Out of the 11 members in the committee, 10 voted against the approval and one was uncertain.
Seven months later in June 2021, FDA granted accelerated approval to aducanumab as a treatment for patients of all stages of Alzheimer’s disease. According to FDA, accelerated approval “allows drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint.” The “surrogate endpoint” for aducanumab was the reduction in the amyloid-beta plaques.
Dr. Patrizia Cavazzoni, Director of FDA Center for Drug Evaluation and Research, wrote in a post-approval statement that the clinical trials data show a reduction in the amyloid-beta plaques, which “is expected to lead to a reduction in the clinical decline of this devastating form of dementia.” Cavazzoni also acknowledged that “the data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit.”
In other words, although Biogen’s clinical trials data failed to prove the drug can slow down cognitive decline in patients, it did show the reduction of amyloid-beta plaque. The FDA awarded speedy approval to the drug based on the assumption that reduction of amyloid-beta plaque “is expected to lead to” a slowdown in cognitive decline in Alzheimer’s patients.
Along with the approval, FDA gave Biogen another opportunity to prove the assumption is true via post-approval trials (phase 4 trials), which is due by February 2030. That is to say, Aduhelm will have been on the market for nine years before proof of its efficacy is required. If the drug maker fails to show the clinical benefit nine years after the accelerated approval, FDA might remove the drug from the market.
One more detail about the FDA approval is that the drug was initially approved to treat patients with all stages of Alzheimer’s disease. One month after the approval, the FDA limited its treatment to patients with early stage Alzheimer’s disease only.
FDA Advisory Committee Members Resign
Within the first week of the FDA approval, three members of the Peripheral and Central Nervous System Drugs Advisory Committee resigned. They were Dr. Aaron Kesselheim at Harvard Medical School, neurologists David Knopman of the Mayo Clinic in Minnesota and Joel Perlmutter of Washington University in St. Louis.
In his resignation letter, Kesselheim called the FDA move “probably the worst drug approval decision in recent U.S. history.” Kesselheim also wrote on Tweeter, “Accelerated Approval is not supposed to be the backup that you use when your clinical trial data are not good enough for regular approval.”
Accelerated Approval is not supposed to be the backup that you use when your clinical trial data are not good enough for regular approval.
Knopman and Perlmutter published a comment in Neurology in July 2021. They wrote, “the clinical benefit amounted to about 3 months’ worth of delay in decline over a year,” referring to the “positive results” in Biogen’s press release in October 2019. They stated, “Combining the results from the 2 trials found no statistically significant clinical benefit for high-dose aducanumab.”
Side Effects and Safety Issues
Brain swelling and brain bleeding are known to be possible side effects of Aduhelm. Biogen conducted two phase 3 studies prior to the FDA approval. The phase 3 studies started in August 2015, but Biogen pulled the plug on both studies three and a half years later, in March 2019. The decision was based on a futility analysis conducted by an independent data monitoring committee, which indicated the trials were unlikely to meet their primary endpoint upon completion. That is, the trials were unlikely to prove the drug’s efficacy in slowing cognitive decline in Alzheimer’s patients.
The safety data from the terminated phase 3 trials were published in JAMA Neurology in November 2021. The study focused on amyloid-related imaging abnormalities (ARIA), which can cause headache, confusion, dizziness, nausea, brain bleeding, and swelling.
The data showed that 425 out of 1,029 patients, or 41 percent, who received the high dose of the drug—the dose that the FDA later approved—experienced either brain swelling or bleeding. Furthermore, 64 patients had to stop participating in the trials because of brain swelling or bleeding.
In September 2021, months after approval, a 75-year-old woman, a clinical trial patient who lived in Canada, experienced brain swelling after receiving infusions of the drug and died a few days later.
The Amyloid-beta Hypothesis
The theory behind the Aduhelm and a slew of other experimental medications for Alzheimer’s disease is the hypothesis that the excessive amount of amyloid-beta plaque in the brain impairs the normal communication within the brain and thus causes cognitive decline.
In fact, the disease is named after the German pathologist Alois Alzheimer, who discovered amyloid-beta plaque in the brain of a patient.
But this hypothesis has not been proven and is by itself controversial.
Three-Quarters of FDA Funding Is From Drug Makers
The Project On Government Oversight (POGO) is a nonpartisan independent watchdog that investigates and exposes waste, corruption, abuse of power, and when the government fails to serve the public or silences those who report wrongdoing.
A two-part investigative report by POGO details the fact that the FDA is in the pocket of the industry it regulates. The report says, “the agency, whose responsibilities include making sure that prescription drugs sold in the United States are safe and effective, receives almost three-quarters of its funding for that work from drug makers.”
Part II of the report exposes the “voice” of the patients at FDA meetings is often funded by drug companies as well.
European and Japanese Agencies Reject Aduhelm
In October 2020, Biogen applied for market permit in Europe. In December 2021, six months after FDA’s accelerated approval of Aduhelm, the European Medicines Agency rejected Biogen’s application to market Aduhelm in Europe.
The EMA considered “the benefits of Aduhelm did not outweigh its risks.” First, the clinical trial results “were conflicting and did not convincingly show that Aduhelm was effective at treating adults with early-stage Alzheimer’s disease.” Additionally, brain scans of some clinical trial patients suggest swelling or bleeding in the brain, which is a significant safety concern.
In the same month, Japan’s Committee on New Drugs also rejected Biogen’s application and requested more data to prove the drug’s efficacy.
