I hear all the views expressed here today about timelines
I hear all the views expressed here today about timelines and HIV Duel and Covid. From a more positive outlook from me being and optimist like I am.
We have a rolling review with our HIV Duel therapy application submission correct? Then the FDA should be continuing to review our BLA as we gather the requested additional information, correct? They don’t just put it on the back shelf and say when you have it all we will review it. As for the timeline for the PDUFA date. It may not be as long as one would think if they are reviewing the information they have currently as they await the additional information to file the BLA. Why would they just start over with a extended 6 month date when they have this big head start?
Granted FDA workload may be heavy during this pandemic. I am assuming they were assigned a team of people to review their application because they know as well as we know that the safety is the most important issue at hand for a covid approval. I believe in good people in every group and the FDA will also have good people that would love to be able to prove our little molecule as the best thing for Covid if it has the data to support it. I believe that Dr. Patterson knows exactly how good the lab results are and the FDA can not overlook that.
Just think about being able to tell your children and grand children how when you worked for the FDA you were on this important review team that approved the drug that saved thousands and thousands of lives. That has to be motivation enough for most people just knowing mankind needs something to help stop this pandemic.
Or maybe I just live in a dream world? But it is nice to dream that people care. That people do the right thing for the good of all. Let’s just hope those people are the ones reviewing right now our BLA.
3
CytoDyn Inc (CYDY) Stock Research Links
Scroll down for more posts ▼
Top 10 Most Recent News Articles
Measuring Truth in AI Coding Here's a doozy: engineers at Sentient Index Labs & Technology have cracked open a way to sniff out whether AI coding models are covering up their errors. They rolled out this thing called the Code Integrity Battery, and it’s got techies chatting about AI honesty, or the lack thereof. It's not about AI writing shoddy code; that we can handle....
Continue Reading
Igniting a Celebration of Appalachian Soul Now here's a sound that hits you right in the gut. Aristotle Jones, known out there as the 'Appalachian Soul Man,' is making a big move. He's laying out the plan to make July the Appalachian Soul Month. This fellow isn't shy about celebrating the deep roots of Appalachian music, dropping his album Appalachian Soul Power and a new...
Continue Reading
A Bold Move to Elevate Roofing Standards In a move that seems to jolt the roofing industry awake, Guaranteed Roof is taking the wraps off its new strategic partnership with LB Capital and EM Exteriors. Think of it as a power trio aiming to redefine what roofing solutions should mean in the Southeast. It’s the kind of news that makes you sit up and ask, why now and why...
Continue Reading
A New Chapter for Diabetes Care: Foodcare Folks, we've got ourselves a game-changer in the world of diabetes care. Listen closely: Foodsmart's latest study, hot off the press from the American Heart Association's Circulation, essentially hands over the blueprint for tackling type 2 diabetes in an innovative fashion. Now, I'm not the type to get all mushy over scientific...
Continue Reading
WareSpace Makes Strategic Moves in Tight Markets In a bold gamble, WareSpace dropped $36.5 million to snag fresh industrial real estate in Miami Gardens, Florida, and South San Francisco, California. These aren't random picks, mind you. They're strategic grabs in markets where finding space ain't easier than winning the lottery. With more than 210 flexible units for small...
Continue Reading
Omneky's New Move: AI Growth Agent Meets Slack Picture this: You've got a marketing team hustling in the digital age, and now they've got a new ally. Omneky, the big-wig in autonomous AI growth, has snuck its AI Growth Agent right into Slack. This isn't just a party trick during Dreamforce week in San Francisco. This is Omneky throwing another cog into the advertising...
Continue Reading
A Veteran Joins EnGenius' Ranks The telecom game, folks, just got a little more interesting with EnGenius Technologies strapping itself in for a channel-first journey across the U.S. and Canada. They've placed a seasoned player, Rachel Saunders, into the cockpit as Vice President of Sales, North America. Her resume reads like a telecom scout's dream: 17 years in electric...
Continue Reading
Every now and then, you stumble upon a story that makes you take off your trading hat and put on your 'citizen of the world' one. The Boundless Futures Foundation is doing just that, pushing past the $1.5 million mark in grant funding to back female founders creating real scale impact. If this doesn't sound like a nonprofit turning the gears of change, I don't know what...
Continue Reading
Metriport's Push into the TEFCA Framework Son of a gun, Metriport's making noise in the health data world! They just got the nod as a Candidate QHIN under the Trusted Exchange Framework and Common Agreement, or TEFCA if you're into acronyms. This isn't just some digital high-five; it's a significant stride forward for healthcare data exchange. Now they're smack in the...
Continue Reading
Pioneering New Ground in Communication The dynamics of leadership communication are undergoing a seismic shift, thanks in part to advances in AI and the insights of seasoned experts like Allison Shapira. Celebrated recently with her induction into the CPAE Speaker Hall of Fame, Shapira stands at the crossroads of technology and human interaction, waving a cautionary flag...
Continue Reading
Top 5 Most Recently Viewed Articles
Understanding the P/E Ratio for Yum Brands Investors Yum Brands Inc. (NYSE: YUM) is a major player in the global restaurant industry, currently priced at $147.91 after experiencing a slight drop of 0.56% in today's session. However, looking at the broader picture, over the past month, the stock has seen a positive growth of approximately 17.67%, and an increase of about...
Continue Reading
Important Insights on Caribou Biosciences Class Action Investing in biotechnology stocks like Caribou Biosciences, Inc. (NASDAQ: CRBU) can often lead you to face uncertain times, especially when class action lawsuits are involved. Recently, Rosen Law Firm has announced a class action lawsuit targeting investors who purchased Caribou securities between specific dates. This...
Continue Reading
HII Enhances Production Through Strategic Partnerships HII (NYSE: HII) is making significant strides in increasing its shipbuilding throughput by collaborating with various shipyards and fabricators across multiple states. This initiative aims to meet the growing demand for naval vessels from the U.S. Navy, expanding the industrial base of shipbuilding while...
Continue Reading
The Excitement of the 2024 World Series The upcoming 2024 World Series is set to be an electrifying event as it features the Los Angeles Dodgers and the New York Yankees, two teams that are not only rivals but also the most valuable franchises in Major League Baseball (MLB). This matchup promises to have a significant impact on Fox Corporation (NASDAQ: FOX) due to its...
Continue Reading
SysAid Earns Recognition in Gartner Report for Generative AI SysAid, a standout company in Enterprise and IT Service Management, has achieved a noteworthy distinction as one of the Emerging Leaders in the recent Gartner report focusing on AI Knowledge Management Apps and General Productivity. This acknowledgment highlights SysAid's commitment to innovation and...
Continue Reading