Think of it this way. When a BLA is submitted it contains a LOT of information in a lot of specific formats. Amarex did such a poor job of compiling and reporting on the safety components of that information that three independent auditing groups said the BLA wouldn't be able to be approved. We know it's not Samsung, and we know it's not efficacy holding us back. It's incomplete, poorly done, or completely missing information that Amarex was supposed to have taken care of for all that money we paid them. The kinds of reports, databases, and results that one would want to sift through to look for any additional signals of adverse events should one or two questionable events pop up, which is exactly what happened. Now, instead of handing over your well executed and catalogued safety information you're handing them over a bag full of crumpled up receipts that Amarex handed over and the FDA is like, "This isn't how this works. You need to properly gather all the information you should have already had, and once we have that and it lines up with what you're telling us you're good."
This is also why Cyrus is waiting to complete this before fully tackling Nash. It's not on hold but we don't have bulletproof safety information to share. At least we didn't until Cyrus started the process properly. It's taking a lot of time because it was a lot of fucked up. They had to gather information from trials that happened many, many years ago.
I don't think there's a ton left they can nitpick about once this last submission is complete. And I think they're asking for an HIV plan because we have ongoing HIV plans with cure and long term dosing, but also because any plan they had submitted in the past is probably garbage because Amarex was involved.
That being said, if they come back with more and this drags out more than another month or two I'll be screaming sabotage like everyone else.
Category: StocksTotal Views: 127 By : EditorUpdated: 05-16-2024
Another Trading Day is Underway
May 16: 2024: the stock market has been showing cautious optimism as several indices hit or nearly hit record highs.
The following is an overview of the present:
Indices Performances:
Dow Jones Industrial Average (I:DJI) Dow Jones holds steady with no daily change: standing at $39.91k. Its trading volume stands high at 411.19 million.
S&.P 500 (I:SPX): It also shows no daily change: with a value of $5.31k and an extensive trading volume of 4.3... Continue Reading
Category: StocksTotal Views: 140 By : EditorUpdated: 05-16-2024
A Dive into Penny Stocks vs. Regular Stocks: Understanding the Contrasts
Have you ever received to the question "penny stocks or regular stocks - which type of stocks can bring me a sky-high investment portfolio?" Picture this: you're at the heart of stock market maize in search of the road that will get you to the milestones in your financial life as well. Knowing the difference between penny stocks with their attraction of the volatile market and regular stocks with its stable... Continue Reading
Category: InvestingTotal Views: 189 By : EditorUpdated: 05-16-2024
How to Determine Your Risk Tolerance: A Step-by-Step Guide
Do you want to be the one who determines your financial future, but be unclear about how much risk you are to judge your investments? Having a clear understanding of your risk tolerance is a must because it's the very first step to be able to choose the right investment decision to be made out of a purpose-built set of the criteria you've listed before. Consequently, the concept of risk tolerance is to each person as diverse a... Continue Reading
Category: StocksTotal Views: 190 By : EditorUpdated: 05-16-2024
Unveiling Hidden Gems: Strategies to Identify Undervalued Penny Stocks
Did you always think about the thrill of this world, the world where undervalued penny stocks roam? Visualize yourself finding gems that have the potential to increase your investment returns by how many times the number of desktops you have in your office, leading to your masters in finance. How would you implement it? There are limitless possibilities of getting rich by picking out the diamonds before they become mass ma... Continue Reading
Category: StocksTotal Views: 148 By : EditorUpdated: 05-15-2024
Market Summary
The major indices all closed in positive territory. The Dow Jones Industrial Average climbed nearly 350 points, or 0.88%, to 39,908. Both the S&P 500 and Nasdaq Composite performed even better, with gains of 1.17% and 1.40% respectively. Meanwhile, April's economic data provided a mixed outlook. While inflation rose 3.4% annually according to the Consumer Price Index, this was a modest decline and within forecasts. Core CPI also aligned with projections, implying easing... Continue Reading
Category: StocksTotal Views: 228 By : EditorUpdated: 05-15-2024
Are Meme Stocks Merely Modern Equivalents of Pump-and-Dump Schemes?
The financial markets have long been a battlefield where contrasting perspectives clash. In recent times, an unconventional combatant has emerged on this terrain - the meme stock. Propelled by social media fervor and grassroots investor passion, these shares have incited spirited debates on fundamentals versus feelings, rational behavior versus irrational exuberance. At the heart of many discussions lies an essential query - ... Continue Reading
Category: MarketsTotal Views: 200 By : EditorUpdated: 05-15-2024
The most recent market mood today was positively affected by a Consumer Price Index (CPI) report, cooler than predicted. This sparked a rise in US stock prices, as the Federal Reserve felt less pressure to increase interest rates. Yet, individual painted a mixed picture. GameStop and Entertainment Holdings suffered significant drops due to the decrease from previous upswings, while Tesla also recorded a decline. However, Apple Inc. saw a small rise in its stock price.
CPI Report: The po... Continue Reading
Category: MarketsTotal Views: 228 By : EditorUpdated: 05-15-2024
Today's market this morning presents a mixed picture with optimism tempered by caution. Looming closely is the consumer price index which will impact the Federal Reserve's decisions on interest rates. This analysis provides a snapshot of major indices, highlights notable events, and issues investment takeaways.
Major Indices Performance:
The Dow Jones Industrial Average stands at $39,558.11. The S&P 500 Index rests at $5,246.68 while the NASDAQ Composite climbs to $16,511.18. A... Continue Reading
Category: Real EstateTotal Views: 244 By : EditorUpdated: 05-14-2024
Plunge into the dynamic cosmos of real estate, a domain where change is the sole consistency! Formed by economic currents, legal changes, and consumer fads, it's a sector that necessitates your concentrated emphasis, whether you're spending or merely working out into a home. Today, we're cutting with the clutter to present you with the most current, essential insights from the core of the industry since May 14, 2024. Get ready for a thrilling trip right into the unraveling trends, ob... Continue Reading
Category: StocksTotal Views: 241 By : EditorUpdated: 05-14-2024
Today the stock market was a combination of positive and negative results, the indices were not moving much, but the meme stocks were the ones that were going up and down. Now, let us see the details of the market activity of today, the leading stocks by the gains and volume, and the factors that contributed to these movements.
Stock Market Updates: Significant Price Changes and Contributing Factors
Cheetah Net Supply Chain Service Inc. was the driver of the stock price leap, gaining 442 p... Continue Reading