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The theory is that American Regent is ramping up their staff to be ready to distribute massive quantities of leronlimab if it gets approved.
Whether or not it has anything to do with CytoDyn, 3 "Warehouse Person" positions were posted today:
Warehouse person
Shirley, NY
Nature and Scope
The functions of a Shipping Warehouse person are that of completing and coordinating the day-to-day operational functions of packing, shipping, and distribution of goods and supplies. A shipping warehouse person is required to work under the administration of warehouse manager and efficiently conduct all duties and responsibilities assigned.
Essential Duties and Responsibilities
--Pick orders according to procedure
--Use power equipment as needed
--Package all shipments to protect product using peanuts/bubble wrap.
--Maintain cleanliness of warehouse.
--Report any problems to Warehouse Leadperson.
--Comply with company policies and follow department Standard Operating Procedures
https://americanregent.wd1.myworkdayjobs.com/en-US/American_Regent_Careers
I would like to share some statistics with you that have a bearing on the likely outcome of the CD12 trial. In our state right now, the most recent statistics show that 67% of the patients in the ICU are on mechanical ventilation. That would place them in the critical category for the CD12 trial. This is an important statistic because we know that the mortality rate in this population was reported to be as high as 80% in the beginning of the pandemic and is probably still at least 35% or higher. If we assume that most or all of patients enrolled in CD12 came from the ICU you can apply the following math:
394 patients in trial
67% critical and 33% severe
394 x 0.667 = 262 critical patients
394 x .333 = 132 severe patients
Now, conservatively assume 40% mortality rate in critical and 15% in severe
262 Critical x 40% mortality rate = 105 expected deaths
132 Severe x 15% expected mortality rate = 20 expected deaths
Total deaths should have been 105 + 20 = 125 for a 31.7% death rate if Leronlimab did not work at all and placebo group was the same as treatment group. Instead, we saw 87 deaths. Assume 90 total since people may have died after we were told 87. That means we had 35 fewer deaths than expected.
The ratio of LL to placebo was 2:1 in the trial, so the number of people treated was 262. Expected deaths in the treatment group is 262 x .317 = 83. However, according to our calculations, we had 35 fewer deaths than expected. If this difference was all due to Leronlimab, the actual deaths in the treatment group were 83-35=48. That would leave 42 deaths in the placebo group. These number represent a statistically significant difference with p<0.05.
Since these are conservative estimates of mortality in each group, this is another indication that we will get very good results from CD12 IMO.
I'll do the "honor-challenged" thing. I haven't published as a biostatistician for nearly 40 years, but ResearchGate still keeps a page in my name with the best-known 8 peer-reviewed articles totaling over 5,000 citations. I have a JAMA co-authorship.
Refuting claims of low power, a colleague handles stats just fine - he back-calculated (if I recall) initial 80% power against low-30%s death reduction to 90% against high 30s.
So the only thing hanging out is that which we discuss incessantly: the death rate in the CYDY control group admitted to the hospitals in the trial at the time we enrolled patients and meeting the severe/critical criteria.
On that we actually have new information today. CYDY recruited lot of patients post-November 1 at our largest site, UCLA.
Per the L.A. Times today, 25% of ALL (not just s/c) Covid patients in L.A. County hospitals died November on:
L.A. hospital death rates double: explained by who gets admitted?
"The chance that a person hospitalized for COVID-19 will die in Los Angeles County has doubled in recent months.
That’s according to an analysis released Wednesday by the county’s Department of Health Services, which found that the chance someone will die from the disease while hospitalized increased from about 1 in 8 in September and October to roughly 1 in 4 since early November."
But:
"Dr. Roger Lewis, director of COVID-19 hospital demand modeling for the L.A. County Department of Health Services, said the increased chance of dying is a result of hospitals being so crowded that only the sickest patients are being admitted."
https://www.latimes.com/california/story/2021-01-21/chance-of-dying-for-covid-19-hospitalized-patients-doubles-in-l-a-county
Seems highly probable that the patient inclusion criteria in the study you cited are not the same as CYDYs CD-12 trial:
Recovery Trial:
“ Inclusion Criteria:
(i) Hospitalised
(ii) SARS-CoV-2 infection (clinically suspected or laboratory confirmed)
(iii) No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial”
To elaborate, the Recovery Trial invited all hospitalized patients, including mild and moderate patients, whereas CD-12 was limited to Severe/Critical patients. There’s also a criteria that’s purely subjective in nature, as the attending physician can exclude patients based on an opinion of their medical history.
I ran my response by a colleague with multiple degrees in pure and granular maths and statistics and he wholeheartedly agreed with me.
(1)
As described in greater detail in the prospectus contained in this registration statement, the shares of common stock to be offered for resale by selling stockholder represent 2,100,000 shares of our common stock issuable upon conversion, at a fixed conversion price of $10.00 per share, of a long-term convertible note issued November 10, 2020, assuming for purposes hereof conversion of the entire outstanding principal balance of $21,000,000 as of January 15, 2021.
NOPE, the results were not publicized - I am not seeing interim results in your PR, just a narrative.
But if you want to carry on with this logic, I'll remind you when CytoDyn PR's the CD-12 results that we've agreed that a PR = publicized results. Agreed?
And by the way, the company you linked didn't release the Interim Analysis results. They simply issued a PR. Where are the interim results??? I want a link to the full results or it's not real.
Thank You.
So they unblinded and took a statistical penalty hit to their final result. CYDY could have done that, but since they didn't, there will be no penalty. That means, statistically, they have better odds to reach statistical significance.
Seems like NP made the right choice; why take a penalty just to satisfy the urge of random internet posters?
All this will be moot when CD-12 FINAL results are announced.
I assure you, everyone here is LAUGHING OUT LOUD.
and it ain't at me.
Post a link to a clinical trial where the interim results were publicized, yet the trial was recommended to continue...
WAITING...
It exists but is not public information. NO BIOTECH COMPANY will release interim results unless they decide to unblind the data at the interim analysis. If the Interim Analysis was made public, the entire trial would be corrupted.
CYDY decided to keep the data blinded until the trial ended, which preserves the integrity of the data to the fullest. This is Clinical Trials 101.
LOL I haven't had a good laugh all day, so thanks.
The DSMB associated with the clinical trial in your post recommended to the company to halt the trial due to futility after conducting the interim analysis. Novartis did not conduct the interim analysis, the DSMB did.
And once again, CYDYs DSMB recommended CONTINUING the trial at the interim analysis. CYDY did not conduct the interim analysis, the DSMB did.
Not sure where we go next...I shall carry on confident that I'm right
The interim analysis was conducted by the independent DSMB, not by CytoDyn. CytoDyn does not receive any results from the interim analysis, they are only provided a recommendation. The DSMB recommended they continue the trial with no modification.
But this is all ancient history...
A response was requested from the poster of the table. First of all, NASDAQ would require positive $5 million in Stockholders' Equity at the time the application for uplist is processed, based on the current SP being over $4. Extending the table through February 31st (LOL) is irrelevant to NASDAQ uplisting. They can only assess stockholder's equity at a singular point in time, as far as I know.
From what I understand, the conversion will wipe out $21 million in Long-Term Convertible Notes Payable, a Liability account on the CYDY Balance Sheet.
The Asset side of the CYDY balance sheet would be unaffected by the conversion. Common stock in the Stockholders' Equity section of the CYDY Balance Sheet would increase in volume by 2.1 million shares. A minor dilutive effect well worth the uplist IMO.
Using the table's cash burn rate of $2.5 million/week, how can we get $-12.5 million cash burn in 4 weeks from end of November to end of December? Are there 5 weeks in November just like there are 31 days in Februrary? The correct math is $-10 million ($2.5 million x 4 weeks). LMAO.
Let's keep the lesson going with the table's $2.5 million cash burn per week just for illustrative purposes. (I actually think the burn rate has decreased now that CD-12 is concluded, but I'll leave that DEBUNKING for another time).
The table has stockholders' equity at $-16.5 million on Jan 15th, but we all agree that it miscalculated the cash burn by an extra $2.5 million, so that puts us at $-14 million on 1/15.
$21 million in retired debt + negative $14 million = Positive Stockholders' Equity of $7 million, $2 million above the NASDAQ $5 million requirement. CYDY would be eligible.
WHATABOUTDAT?!?
What happens on FEBRUARY 31st?
As a CPA, I can assure the entire board that this calculation is utterly false and FUDULENT. There are no pending lawsuits against CYDY either.
DEBUNKED
AH AH AH WHATABOUTDAT?!?
I have an inside connection over at the Wolfson family office. While he’s a junior level agent of the company, he does track CYDY daily. According to him, 90% death rate. I really trust this guy and so should CYDY investors.
It means the SEC is investigating CYDY stock manipulation by naked shorts.
My 2 Cents...!!!
I hope..I think..I believe with all my heart that our CD12 results will be SPECTACULAR..!!!
What does a delay in reporting results mean..?? Delay as in disclosing results at the end of January or early February..?? ANYONE..???
Would CYDY continue to administer eIND’s..Continue Enrolling patients at our CD12 participating sites..Who meet the Inclusion/ Exclusion criteria.. While knowing Leronlimab in not effective against Covid..?? Could we be another GILEAD or Humanigen.. CORRUPTED COMPANIES..WHO’S GOD IS THE ALMIGHTY DOLLAR..???
I THINK NOT..!!! CYDY has too much class..integrity AND THE INDEFATIGABLE DESIRE TO HELP MANKIND..As is obvious in the actions of its officers ..TO PERPETUATE A GILEAD LIKE CRIME ON THE AMERICAN PUBLIC..!!!
CYDY STRONG..CYDY LONG..!!!
IMHO
Nailed it, thank you for having more patience than I to break it down so well.
Nope, you’re wrong yet again. NP was asked how many patients have died so far. He wasn’t asked how many patients have died within the 28-day protocol. The point is that he could be counting patients that died outside the 28-day period after their last treatment. The fact that the DSMB recommended a 42-day review supports the notion that a significant number of patients are dying between days 28-42.
Since NP did not make this distinction, everyone is just speculating on death numbers.
Black Ops - you hit the nail on the head. Good work detecting that this trial ‘analysis’ is bogus and FUDulent, much like the Citron hit piece.
I don't know if anyone else has noticed, but whenever someone brings up the 6/30/20 CYDY shorting orgy, at least a poster or two will respond with comments intended to counteract the notion that it was due to the actions of "short sellers", almost as if their lives depended on nobody thinking that 6/30/20 was caused by "short sellers". Same phenomenon on Twitter and other message boards.
I can smell the fear in those posts.
All longs thought they would hear something meaningful: Categorically false
The reaction was disappointment: Categorically false
They're in dire straights financially: False, 10-Q showed $29.4 million. In my opinion, that does not constitute dire straits. So this is just your subjective opinion.
Bankruptcy is a clear possibility: See above.
Thanks Chuckles. I’ve peaked at this before to keep up on the methods biotech companies use to value and report pre-launch inventory. Definitely recommended reading for folks here. The more you know, the easier it gets to navigate through the 10-Q FUD.
Once again, Work-in-Progress is an asset according to GAAP, this is Accounting 101:
KEY TAKEAWAYS
A work-in-progress (WIP) is the cost of unfinished goods in the manufacturing process including labor, raw materials, and overhead.
WIPs are considered to be a current asset on the balance sheet.
https://www.investopedia.com/terms/w/workinprogress.asp
During the quarter ended November 30, 2020, in connection with the Samsung commitments as described below in Note 10, the Company negotiated non-standard payment terms for certain payables. The agreed upon payment terms resulted in due dates beyond one year of our reporting date. The non-current accounts payable balance as of November 30, 2020 was $34.3 million
During the quarter ended November 30, 2020, in connection with the Samsung commitments as described below in Note 10, the Company negotiated non-standard payment terms for certain payables. The agreed upon payment terms resulted in due dates beyond one year of our reporting date. The non-current accounts payable balance as of November 30, 2020 was $34.3 million
Nader is a brilliant negotiator, apparently. Looks like they got a long extension to pay the remainder of the 2020 Samsung balance.
DEBUNKED
Unaudited doesn’t mean non-GAAP. Prove that anything in this 10-Q is not according to GAAP.
They owed Samsung $19 million as of 11/30/20 for their 2020 payment commitments:
The Company estimates initial ramp-up costs to manufacture commercial grade leronlimab at scale could total approximately $127 million, with approximately $64 million payable over the course of calendar year 2020, of which $45 million has been paid as of the date of this filing, approximately $37 million payable during calendar year 2021, and approximately $26 million payable in calendar year 2022.
The $99 million in inventory represents their ever growing inventory of manufactured leronlimab. It is correct accounting to report the leronlimab inventory as an asset. The payment schedule has nothing to do with the reported inventory. What they owe Samsung is reflected in current and long term liabilities.
The link to the study has already been provided "Thanks CT" (it was in the body of the Seeking Alpha story as well).
Borrowed from another board, not independently verified:
This was the condition of the control group:
None/supplemental oxygen only: 2/402 (0.5);
High flow nasal cannula: 110/402 (27.4)
Non-invasive ventilation only: 169/402 (42.0)
Invasive mechanical ventilation: 121/402 (30.1)
Vasopressor support: 79/402 (19.7)
Mortality control group: 35.8% (142/397)
Ask someone who cares
Control group in this study had 35.9% mortality rate. Ready to reassess your statement?
https://seekingalpha.com/news/3649703-roche-sanofi-treatment-combo-improves-survival-rates-in-covidminus-19-study
Of course it can. The author of the thread, a public critic of CytoDyn, has little to no understanding of statistics, maths, research, and especially science. He has been debunked at least 100 times on Twitter by persons with superior intellect and understanding of biotech investing. What a waste of time.
I don't fall for what·a·bout·ism:
The technique or practice of responding to an accusation or difficult question by making a counter-accusation or raising a different issue.
Whataboutism, also known as whataboutery, is a variant of the tu quoque logical fallacy that attempts to discredit an opponent's position by charging them with hypocrisy without directly refuting or disproving their argument. Whataboutism is particularly associated with Soviet and Russian propaganda.
I am only interested in debunking organizations such as BuyersStrike because I want to protect my investment in CytoDyn.
On January 4, 2007, the SEC charged Defendant Joseph Spiegel of Buyersstrike with securities fraud in connection with his activity when he was a portfolio manager for Spinner Global Technology Fund, Ltd. (“SGTF”), a $200 million hedge fund. See Complaint, SEC v. Joseph J. Spiegel
https://www.sec.gov/litigation/complaints/2007/comp19956.pdf
(Jan. 4, 2007).
According to the SEC Complaint, Spiegel “engaged in an unlawful trading scheme . . . in violation of the antifraud and registration provisions of the federal securities laws."
Why would anybody take him seriously or think he has a shred of credibility? His attacks against CytoDyn are not journalism, they are hit pieces coordinated with a network of short sellers.
Spiegel has been engaging in a fraudulent scheme to profit from illegal and manipulative short selling in CytoDyn’s stock. He does so by coordinating the publication of false and misleading “hit pieces,” masquerading as stock “research” articles, with manipulative trading and quoting activity in CytoDyn’s stock. Spiegel conspires to drive down the price of stock by timing the publication of false and misleading hit pieces with illicit, manipulative trading tactics and quoting activity, including “naked” short sales.
Short sellers like Spiegel are stock traders who sell stock that they do not own to make a profit when the price of a stock goes down. In brief, a short seller locates stock to borrow, sells it for the current market price, and then hopes the price of that stock will decline so he can purchase it in the open market at a cheaper price before returning it to the borrower.
A short seller is required to locate stock to borrow before selling it to ensure that he has a reasonable belief that the stock can be delivered on a specific date. While short selling itself is not illegal, “naked short selling”—selling stock short without first borrowing shares—is plainly illegal under the federal (and many state) securities laws. Naked short selling is sometimes coupled with efforts to fraudulently manipulate the market to drive down the stock price because short sellers need to be certain that the price of the stock will decrease. Most commonly, these efforts take the form of disseminating false negative information about the company to the investing public. If the short seller successfully convinces investors that the company represents a worthless investment, plummeting the company’s stock price, the short seller can walk away with significant profits, while the company’s financial well-being and reputation are severely and irreparably damaged. This type of fraudulent scheme has been an unfortunate element of the public stock markets for decades.
With the rise of the Internet and the advent of social media, short selling—and attendant market manipulation—has developed into a complex, highly sophisticated enterprise. Once a short seller establishes a short position (i.e., once he locates shares to borrow and sells a stock), a network of individuals goes to work, writing, publishing, and promoting what appear to be legitimate works of journalism aimed at exposing negative facts about a company to the investing community, but are in fact complete fabrications. The conspirators benefit from the anonymity permitted by Internet-based publishing, and their “hit pieces” reach a vast audience almost instantaneously by linking to the articles on sites like Twitter and Facebook.
In conjunction with disseminating false or misleading negative information, short attackers engage in a host of deceptive and illegal trading practices that are designed to artificially manipulate stock prices. These tactics include “naked short selling,” “spoofing,” “layering” and “wash trades,”—all of which are plainly illegal under the federal (and many state) securities laws.
CYDYs dealings with the Philippines are not on the call agenda.
Nice work sniffing out this deceptive FUD about CYDY.
Here’s the text from today’s WSJ long hauler article:
A series of Wall Street Journal articles about long-haul Covid patients, who suffer from debilitating symptoms for months after their initial diagnosis, prompted readers to share their own stories. Some described their experiences with long Covid, which can include brain fog, severe fatigue and racing heart rate. Other readers shared their experiences with a disorder called POTS, a little-understood syndrome that existed before Covid but is being diagnosed more often in people with post-acute Covid symptoms.
Here are edited excerpts of their comments.
I am from Tucson, diagnosed with coronavirus on June 15. I don’t think people believe the symptoms we have are real.
The stories of the others prompted me to write. My symptoms are similar. Hard to breathe, racing heart, numbness and tingling, tight and heavy feeling in my chest, aching in various body parts, sometimes headache, ringing in my ears. Some days are better but after I go and do something—shop, cook, relax in the pool, or walk farther than the mailbox—I am done for the day. And I can’t stay focused, can’t work seated at the computer for more than 30 or 40 minutes without getting confused and frustrated.
Thank you for letting me share this. No one else is listening.
Morgan Egan-Murphy, Tucson, Ariz.
Stephanie Zeidenweber and I live maybe five minutes down the street from each other. Both of us got sick. Both of us had asthma as children but we’re both extremely active in our present lives.
Even though we have similar friends, we never met each other until we got sick. We lean on each other because nobody else understands what we are going through except for those in our support groups. We have been sick with identical stories and symptoms for the same amount of time.
Today I’m having a bad breathing day, which Stephanie dealt with for the past three days. When I get up, my oxygen levels go down and my heart rate spikes. Sometimes this will go back to normal again, and I will have a full sense of relief for a short period of time until it starts all over again.
Stephanie Bregman, Boca Raton, Fla., with Stephanie Zeidenweber, Delray Beach, Fla.
My 17-year-old daughter got Covid in early March. She mentioned that she was smelling “pad Thai” or dirty rags all the time, but I ignored her as I myself was working in the Covid ICUs during the surge as an intensivist, and felt totally overwhelmed.
My daughter still can’t smell. We had a near fire in our kitchen last month from burned popcorn in the microwave, and she couldn’t smell the smoke. She experiences a disturbing smell most of the time. Although better than it was in March, her sense of smell is altered, and she gets no pleasure from scents that used to be enjoyable.
Dana Lustbader, Great Neck, N.Y.
I’m 22 years old and I’ve had POTS for about three years. Becoming chronically ill flipped my life upside down. Now I’ve learned how to live with POTS, as well as my overlapping chronic health conditions.
There is a huge community of POTS patients who have been battling this condition for many years, pre-Covid, with little to no light ever shed on our struggle. There are still some doctors who refuse to treat it because they don’t believe it’s real.
Becoming chronically ill, especially if you were healthy before, can be one of the most isolating experiences of one’s life. It was for me. It took me years to find doctors and resources to help me feel less alone in my experience and battle with this condition. There is a community waiting to support and embrace post-Covid patients entering the realm of long-lasting illness for the first time.
Catherine Ames, Carlsbad, Calif.
Mako Research...hmmm, that seems to ring a bell. Ah yes, now I remember, that's Joseph Spiegel's blog. Or it used to be his blog until it dissolved in the wake of the Abeona lawsuit https://iapps.courts.state.ny.us/nyscef/ViewDocument?docIndex=pIKsFTWq6bTkeqJwsPwYew==.
Joe now blogs as BuyersStrike, where he continues to pen short & distort articles about CytoDyn, Leronlimab, and Nader Pourhassan.
In fact, Joe's team of sycophants frequently link his articles to this message board, making it perfectly legitimate for CytoDyn message board members to discuss and respond to public figure Joseph "Joe" Spiegel of BuyersStrike.