Well... good thing we arent using SYRINGES R US. Un

New Post Public Reply Private Reply Replies (4) Message Board
Normy
962
Well... good thing we arent using SYRINGES R US. Un freaking believeable that the FDA's comment hanging things up is the name of the syringe manufacturer. (that apparently was in the package and just "missed" by someone. I know this type of bureaucrat. wait till the last minute for response and send a BS request that ultimately was in the BLA just to kick the can down the road. "oh sorry, i didnt see that..." i can hear it now.)

Also from reading between the lines, i think the analysis they are requesting most likely comes down to a bigger spreadsheet with more columns of the same data that is in the BLA. "well... it would make it easier to analyze if it was presented on the same sheet"

I see this everyday in the construction industry waiting on building permits to be approved by people who are not really qualified to review construction drawings. They find the misspelled words but miss the fire wall concerns.

And NP has to do the CEO routine and say how much the FDA is helping and how great they are. It is literally margaret in record keeping in cube 2305 on the 5th floor that wants another box checked so it can be resubmitted where it will proceed to sit on someones desk for 4 months, rubber stamped to sit on another desk for 1 month and so on and so on, until the deadline gets reached and miracuously gets processed across 5 additional desks in 2 weeks.

I s*** you not! I bet you 10,000 shares that is basically what this comes down to.

These comments from the FDA were not substantive at all and actually ridiculous. The biggest error was PRing this without better messaging.

"FDA is requesting syringe manufactuer name as well as current clinical data to be presented in an alternative manner to facilitate FDA process review. Cytodyn will provide this information ASAP." Done!

CytoDyn Inc (CYDY) Stock Research Links

CYDY Board Company Profile Buy Rating Time & Sales News Filings Financials
Scroll down for more posts ▼

Top 10 Most Recent News Articles

AST SpaceMobile Faces Class Action Over Misstatements

Updated Category News Views 4

What's Going On with AST SpaceMobile? Kicking off with a heavy hitter here, folks. AST SpaceMobile, Inc., trading under NASDAQ:ASTS, is under a securities fraud spotlight. We're talking allegations piled higher than a morning stack of pancakes. If you picked up any ASTS shares between March 4, 2025, and July 15, 2026, you're in on this rough ride. There's a class action...

Continue Reading
HONA Faces Legal Heat: Investor Lawsuit Over Losses

Updated Category News Views 6

The Investor Storm Brewing Over Honeywell Aerospace There it is again, another industry heavyweight caught in a dizzying whirlwind of litigation. Honeywell Aerospace Inc. (NASDAQ:HONA), a name as established as an old boot in the business, now faces a class action lawsuit that's got investors frantically dusting off phone numbers for their attorneys. The Messy Allegations...

Continue Reading
Cut Winter Heating Costs with Townsend's Rebate Help

Updated Category News Views 6

Unseen Perils of Winter Heating in Massachusetts Massachusetts homeowners, listen up. If your heating system is older than the Model T, it's time to rethink your winter strategy. You don't want to be stuck in the cold when the thermometer hits single digits, do you? That's where Townsend comes in, making waves with their rebate assistance program. Navigating the Rebate...

Continue Reading
Jackson Wang's Fantasy IP Hits Hong Kong Stage

Updated Category News Views 5

A Star-Studded Fantasy Comes Alive Hong Kong isn't just about dim sum and skyline views—it's a magnet for celebrity showcases, and this time, Jackson Wang's pulling the strings. The guy's ventured beyond music and idol fame, diving head-first into creative visuals with his fantasy IP, "Under the Castle" (UTC). Pairing up with Ocean Park's Halloween Fest, he's cooked up...

Continue Reading
Krispy Kreme Faces Legal Probe: Fiduciary Breach?

Updated Category News Views 3

Diving Deep into the Krispy Kreme Allegations Look, this isn't your run-of-the-mill donut drama. When you hear rumblings of corporate missteps, especially ones that involve potential breaches of fiduciary duties, it's time to perk up those ears. Over at Krispy Kreme, Inc. (NASDAQ:DNUT), there's some heat in the kitchen, and it's not just from frying those glazed beauties....

Continue Reading
Farm Aid 2026: A Resilient Tribute to Family Farmers

Updated Category News Views 4

Shining a Light on Essential Family Farmers Every year, thousands gather for Farm Aid to back the unsung heroes who put food on our plates. In 2026, the scene shifted to the amphitheater at Virginia Beach, where an epic lineup of music took stage not just to entertain but to underline a critical issue—family farmers are fighting for survival. These folks aren't merely...

Continue Reading
Quay Sunglasses: Luxury Looks, Affordable Prices

Updated Category News Views 3

Ah, sunglasses—the quintessential accessory that screams both practicality and style. A million-dollar look without the million-dollar expense? That's where Quay comes in. They've been recognized by Expert Consumers, no less, as some of the best-in-class for affordable luxury eye candy out there—aimed at shoppers who want the designer vibe without the hemorrhaging...

Continue Reading
Timur Turlov Leads FIDE with Chess and Digital Focus

Updated Category News Views 5

An Unpredicted Victory in Samarkand Well, color me surprised. Timur Turlov's made waves by clinching the role of FIDE President at the General Assembly in Samarkand. This one's quite the turn for the chess world—Kazakhstan’s own stepping up to run the whole show. This isn't just some ceremonial post either. Turlov, who's been pulling strings over at the Kazakhstan...

Continue Reading
China Southern Airlines Marks 70th Anniversary in NYC

Updated Category News Views 4

Taking Flight with Legacy and Tradition Throwing a bash on Times Square isn't just about flash; it's about letting folks know you mean business. And China Southern Airlines has been doing just that for 70 years. Imagine starting from Guangzhou and ending up splashed across New York City's giant LED screens—talk about a journey! From Humble Roots to Global Network...

Continue Reading
PACS Group Faces Legal Scrutiny: What to Watch

Updated Category News Views 4

PACS Group: Legal Storm Brewing Welcome to the latest saga in the volatile theater of corporate governance. PACS Group, Inc., ticker symbol NYSE:PACS, is under the microscope, and not for debuting a groundbreaking product or hitting a stock milestone. Nope, instead we've got Halper Sadeh LLC out of New York investigating some possible hanky-panky from PACS directors and...

Continue Reading

Top 5 Most Recently Viewed Articles

BrilliA Inc Successfully Completes Public Offering on NYSE

Updated Category News Views 484

BrilliA Inc Marks a New Chapter with IPO Completion BrilliA Inc (“BRIA” or “the Company”) has recently taken a significant step by closing its initial public offering (IPO), marked as a defining moment in its growth trajectory. The Company’s plan detailed in their offering included the distribution of 2,500,000 Class A Ordinary Shares, priced at $4.00 each,...

Continue Reading
Understanding the Decline of TQQQ: Insights for Investors

Updated Category News Views 524

Understanding the Decline of TQQQ: Insights for Investors ProShares UltraPro QQQ, known by its ticker TQQQ, has recently experienced a notable decline, trading down by 4.14% to $58.60 in afternoon trading. This drop occurs amidst a backdrop of turbulence in major stock indexes, signaling caution among investors. Additional contributing factors include economic indicators...

Continue Reading
ISC Plans to Announce 2024 Q3 Financial Performance Soon

Updated Category News Views 48

ISC’s Upcoming 2024 Third Quarter Financial Results Announcement Information Services Corporation (TSX:ISV), headquartered in Canada, is gearing up to release its financial results for the third quarter, which concluded on September 30, 2024. This significant disclosure will take place on November 5, 2024, after the market closes. Interested stakeholders can access...

Continue Reading
Transforming Travel: Key Insights for Future Journeys

Updated Category News Views 271

Transforming Travel with Purpose and Experience In an ever-evolving world, the landscape of travel is taking a significant turn, focusing on meaningful experiences rather than mere destinations. A recent report from Trip.com Group and Google has unveiled key trends that will shape the travel industry through 2026 and beyond. The emphasis is shifting to Expression,...

Continue Reading
Thsyu Exchange Launch: Revolutionizing Crypto Trading Ahead

Updated Category News Views 255

Thsyu Exchange Launch: A New Era in Cryptocurrency Trading Thsyu Exchange is excited to unveil its official launch, a pivotal moment in the cryptocurrency trading landscape. With an emphasis on innovation, security, and user empowerment, Thsyu is poised to redefine the way traders engage with digital currencies. By harmonizing robust technology and user-friendly...

Continue Reading