Ocugen to restate results

 

• The Company intends to restate its consolidated financial statements as of and for the year ended December 31, 2022, in connection with the filing of its 2023 Form 10-K. Similarly, the Company will include restated unaudited financial information for each of the first three quarters of 2023 and 2022 in its 2023 Form 10-K (each such annual and quarterly period to be restated, a “Restated Period”).
  
• The identified errors in each of the Restated Periods relate to the Company’s non-cash accounting for the estimated costs in one of its collaboration arrangements. However, the Company does not expect the errors to result in any impact on its cash position, cash runway, or financial projections.
  
• Ocugen’s cash, cash equivalents, and investments totaled $39.5 million as of December 31, 2023, compared to $90.9 million as of December 31, 2022. The Company estimates that its current cash, cash equivalents, and investments will enable it to fund its operations into the fourth quarter of 2024. The Company had 256.6 million shares of common stock outstanding as of December 31, 2023.
  

Conference Call and Webcast Details

Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

Attendees are invited to participate on the call or webcast using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 4947142
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

https://www.globenewswire.com/news-release/2024/04/02/2855922/0/en/Ocugen-Provides-Business-Update-with-Certain-Financials-for-the-Year-Ending-2023.html

Biden administration approves eighth US offshore wind project

The U.S. Interior Department on Tuesday approved the country's eighth commercial-scale offshore wind project, which will be built off the coast of Massachusetts, bringing online electricity to power more than 900,000 homes.

The New England Wind Project approval brings the U.S. one-third of the way to President Joe Biden's goal of permitting 30 gigawatts of offshore wind capacity by 2030 - a key part of the president's climate change agenda.

The project comes just a week after the Interior Department approved another offshore wind project in New York. The approvals this year follow a series of attempts by companies including Equinor, BP, Avangrid and Shell, to cancel or seek to renegotiate power contracts for commercial-scale U.S. wind farms due to supply chain concerns and high materials costs.

“The Biden-Harris administration has built an offshore wind industry from the ground up after years of delay from the previous administration," said Interior Secretary Deb Haaland.

The New England Wind project, located around 20 nautical miles south of the Massachusetts island of Martha's Vineyard, is expected to generate up to 2,600 megawatts of electricity.

https://finance.yahoo.com/news/biden-administration-approves-eighth-us-100901580.html

Galapagos Downgraded on Slow Pipeline Progress: B of A

 Bank of America Securities downgrades European drugmaker Galapagos NV 

GLPG-1.55%

+ Free Alerts

 to underperform, citing few catalysts in the near term.

Galapagos’ enterprise value has been consistently low, ranging between $1.5 billion and $2 billion, and the analysts don’t anticipate any immediate or medium-term solutions to this. 

Additionally, the company’s main programs are entering crowded markets where differentiation is unclear, and there is a lack of significant catalysts to drive growth.

Galapagos’ primary cancer pipeline requires 3 to 4 years to reach the market, accompanied by significant cash depletion and uncertain standing in fiercely competitive markets. 

Moreover, Galapagos’ emphasis on acquiring early-stage assets increases the risk for investors, potentially leading to a decline in the stock price. 

BofA Securities’ downgrade to “Underperform” from “Neutral” is due to concerns that the stock may continue to be a value trap and underperform compared to its peers. The analyst lowered the price target from $41 to $31.

Galapagos is currently conducting three early-stage trials to assess its autologous cell therapy (CAR-T) treatments for hematologic cancers. 

The unique selling points of Galapagos’ CAR-Ts lie in their potential differentiators:

• Speed: Galapagos aims for a swift 7-day manufacturing turnaround time, quicker than the typical 30-day timeframe seen in most competitor programs. However, competitors like Gilead Sciences Inc 
  GILD-0.75%

  Get Free Report
   are also working on reducing this time frame, with lymphoma programs reaching a 14-day turnaround and showing signs of improvement.
• Supply: Galapagos has developed an automated manufacturing model that could eliminate some current production bottlenecks. However, being a late entrant (fifth) in most key markets poses a risk, as competitors may address supply issues before Galapagos can enter the market.

Thus, BofA sees a smaller commercial opportunity for Galapagos’ CAR-T candidates and lower revenue forecasts by 15-25% in out-years (2028E+).

https://www.benzinga.com/analyst-ratings/analyst-color/24/04/38030693/galapagos-downgraded-pharma-firm-faces-uphill-battle-with-slow-pipeline-progress

FDA's Anti-Ivermectin "You Are Not A Horse" Post Remains Up As Court Order Deadline Looms

 by Matthew Lysak via The Epoch Times,

Eleven days after a court-ordered settlement required the U.S. Food and Drug Administration (FDA) to remove all social media and directives regarding ivermectin, a webpage and its most infamous post remains online, advising people against the use of the popular drug.

After years of controversy over using ivermectin to fight COVID-19, the FDA agreed to remove its social media posts urging people to stop using the drug, according to a settlement filed with federal court in southern Texas dated March 21.

The agency has already removed a page that said: “Should I take ivermectin to prevent or treat COVID-19? No.”

However, its Aug. 21, 2021, post on X (formerly Twitter)—in which the FDA wrote:

“You are not a horse. You are not a cow. Seriously y’all. Stop it”—continues to remain live on the social media platform.

At the time of publication, the post had been reposted more than 67,000 times.

Further, a page on the agency’s website titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” also remains live, in which the agency states that the “FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals.” The page also says no data exist showing ivermectin to be effective against COVID-19, despite studies that show the drug to be effective against the disease.

Dr. Mary Talley Bowden, a practitioner in Texas and founder of the Coalition of Health Freedom, told The Epoch Times that she believes the agency is delaying the inevitable to avoid further public ridicule.

“My guess is they’re hoping all the negative publicity over the case will die down, and they can quietly remove them without as many people noticing,” said Dr. Bowden, who was among a group of doctors who initially filed a lawsuit against the FDA.

“We have three years of false propaganda to overcome regarding ivermectin,” she added.

According to the terms outlined in the settlement, the agency has 21 days to “delete and not republish” web pages and several media posts, including an April 26, 2022, social media post that reads: “Hold your horses y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”

In exchange for removing the posts and webpages, doctors who sued the agency are dismissing their claims, the filing states.

An FDA spokesperson was not immediately available for comment but had previously told The Epoch Times in an email that the agency “has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old.”

Ivermectin has been around for decades but became the center of controversy in 2020 after medical opinion became divided over its effectiveness as a treatment for COVID-19. In the aftermath, many pharmacists refused to fill prescriptions for the medication.

By 2023, the issue had made its way into a courtroom in a case brought by Dr. Bowden and other medical professionals when, on Aug. 8, a lawyer representing the FDA confirmed that doctors were free to prescribe ivermectin to treat COVID-19.

“FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, told the U.S. Court of Appeals for the 5th Circuit.

Despite statements from the FDA affirming that right to doctors, many pharmacists nationwide continue to refuse to fill prescriptions for ivermectin issued to patients for the treatment of COVID-19, according to Dr. Bowden.

In most cases, according to Dr. Bowden, individual pharmacists aren’t to blame and often only carry out orders from corporate leadership. However, she claims to have also seen examples where pharmacists prevented her patients from getting their medication because of their own “personal agenda.”

Further, the longer the FDA posts remain up, the more difficult it is for physicians to ensure that patients receive the care needed, according to Dr. Bowden, who added that a pharmacist refused to fill an ivermectin prescription she had written last week.

“I’ve treated over 6,000 COVID patients using a combination of medications, including ivermectin,” said Dr. Bowden. “All of my patients who received early treatment are alive and well.

“The sooner they remove the posts, the better, but we have a lot of work to do to reeducate the public,” she added.

The FDA has until April 11 to delete the remaining posts, according to the settlement.

https://www.zerohedge.com/medical/fdas-anti-ivermectin-you-are-not-horse-post-remains-court-order-deadline-looms

Hunter Biden's motions to dismiss tax charges all denied

 U.S. District Judge Mark Scarsi on Monday denied all eight of Hunter Biden's motions to dismiss the nine federal tax charges he faces in California. 

At a hearing last week, Hunter Biden's attorney primarily argued that the charges against him were part of a politically fueled prosecution. Special counsel David Weiss' office rebutted those claims, arguing politics had no bearing on the facts of the case.

Judge Scarsi also appeared skeptical of Biden's arguments. In his order Monday, Scarsi said Biden failed to provide "clear evidence" of discriminatory purpose and provided only "conjecture" about prosecutorial decisions made in the case.

"We strongly disagree with the Court's decision and will continue to vigorously pursue Mr. Biden's challenges to the abnormal way the Special Counsel handled this investigation and charged this case," Biden's attorney, Abbe Lowell, told CBS News in a statement.

Biden has pleaded not guilty to all charges.

Federal prosecutors allege President Biden's son engaged in a "four-year scheme" to avoid paying at least $1.4 million in federal taxes. In December, they charged him with felonies and misdemeanors related to his alleged failure to file and pay taxes, evasion of assessment and filing a false or fraudulent tax return. 

ADVERTISEMENT

Prosecutors say Hunter Biden had earned more than $7 million in gross income when he failed to pay taxes and said he funded an "extravagant lifestyle" and evaded taxes by classifying some personal expenditures — such as luxury hotel stays, luxury vehicle rentals and escort services — as business deductions.  

If convicted, he faces up to 17 years in prison.

Another key argument made by Hunter Biden's counsel was that the tax charges violated a legally binding diversion agreement made last year. But prosecutors argued the proposed agreement had not been approved by the U.S. Office of Probation and had not yet gone into effect. Scarsi found that Hunter Biden was not granted immunity from the charges.

https://www.cbsnews.com/news/hunter-biden-motion-dismiss-tax-charges-denied/

Waste of the Day: Feds Paid $1.3 Billion To Dead People Last Year

 Topline: The federal government mistakenly paid $1.3 billion to dead people in fiscal year 2023, according to U.S. Office of Management and Budget’s reporting on improper payments.

Key facts: Some living souls collected checks for the deceased through alarming examples of fraud at the expense of the IRS, Veterans Affairs Department and Medicare, the Washington Times reported.

Waste of the Day 4.02.24

Open the Books

One Washington man, Raymond Kenneth Musgrove, impersonated a Vietnam veteran for more than 25 years to collect his disability and health care benefits, the news outlet reported.

When the real veteran died in 2018, the VA cut off benefits — until Musgrove convinced them the veteran was still alive.

Payments stopped again once the VA inspector general found the veteran’s tombstone in an Oklahoma cemetery, but Musgrove somehow duped the VA again and payments restarted, the Times reported.

Musgrove collected $825,000 before his indictment this February.

A woman in Ohio kept a similar scam going for 48 years, lying to the VA seven times to collect benefits for her dead mother, until being caught in 2021, the newspaper said.

Background: Not all improper payments are quite so amusing, but they do amount to a staggering amount of taxpayer money thrown down the drain.

OpenTheBooks previously reported that the federal government spent $2.9 trillion on improper payments between 2004 and 2022, adjusted for inflation. That’s 8% of the current $34.5 trillion national debt.

Another $236 billion was incorrectly paid in 2023, according to the Government Accountability Office.

Of that, $1.3 billion were payments made to dead people.

Summary: While completely eliminating improper payments is unlikely, cutting off funds after seeing the beneficiary’s tombstone is a good place to start.

The #WasteOfTheDay is brought to you by the forensic auditors at OpenTheBooks.com

https://www.realclearinvestigations.com/articles/2024/04/02/waste_of_the_day_feds_paid_13_billion_to_dead_people_last_year_1021259.html

Compassionately Communicating Life

 In 2022, the pro-life movement experienced a massive victory: For the first time in 50 years, the Supreme Court returned decision-making about abortion back to the states – to the people.

Immediately after, the left and their allies in the media eagerly continued their half-century-long disinformation campaign to confuse the American people about what the ruling actually meant. Democrats lied to the American people that abortion had now been banned entirely, that mothers receiving abortions would be prosecuted, or that back-alley abortions would suddenly become the norm.

None of that is true.

And in this election cycle, Democrats will once again purposefully deceive the American people on this issue. We cannot allow these blatant lies to spread and must talk about life issues with truth, compassion, and hope.

Every pregnancy involves two lives: a mom and an unborn baby. As South Dakota’s largest healthcare provider testified to our state legislature this past February, “We recognize that each time a mother walks through our doors, we’ve been entrusted with the health of two patients: the mother and the child.”

In my state, we showed moms we are here to help them – that they are never alone. We expanded Paid Family Leave access for state employees; provided pregnancy counseling, resources, and tips on parenting; pointed moms and families towards available financial assistance; and even offered help on adopting a child or giving a child up for adoption. We created Bright Start to match first-time moms to available nursing services during pregnancy and up until their child’s second birthday.

There’s more to do, but South Dakota stepped up and protected mothers and their babies with significant policy prescriptions designed to address many concerns. I’m a pro-life governor, and I’m proud of what we’ve done in my state. But what we support in South Dakota may not have support in South Carolina. That’s what the Supreme Court decision actually did – turn those issues back to the people in each state so they can decide.  

I realize many in my own party don’t want to talk about this issue. However, the national conversation about abortion will only increase as we approach the November elections. Republicans should not and cannot be afraid to defend our position to protect mothers and their babies, expose lies from the left, and go on offense to expose the radical left’s extreme position on abortion.

The radical left claims “abortion access is being restricted,” but more abortions took place in 2023 after the Supreme Court decision than in the years prior. The left says pro-life laws will lead to higher maternal mortality, but maternal mortality actually dropped by 60% in South Dakota in the first full year after the Court’s ruling. We have to expose that every Democrat in the U.S. Senate voted to allow abortion at any time, for any reason, right up until the moment of birth, and they demanded that you pay for it. Polling by Rasmussen shows a vast majority, 86% of the American people, reject the Democratic Party’s position.

A majority of the people clearly agree with us on this issue and many others facing America.

It’s bad enough that Democrats can’t define what a “woman” is – they also continue to belittle us by portraying women as single-issue voters who only care about abortion. The fact is only 16% of women in Michigan – a key swing state in the upcoming election – are single-issue abortion voters. While abortion will undoubtedly be an issue in the 2024 elections, polls show women care more about how illegal immigration is making them less safe in their communities, how persistent high gas and food prices cause them to struggle to take care of their families, and how America’s decline on the world stage will shape their kids’ future.

Simply put, the America First Conservative policies are proven to be successful – and represent the best hope for a healthy, happy, and prosperous life for Americans who are born and unborn. This is the fight, and if we’re going to win hearts and minds, we can’t be afraid to enter the ring.

Kristi Noem is the governor of South Dakota.

https://www.realclearpolitics.com/articles/2024/04/02/compassionately_communicating_life_150737.html