When is a Conference Presentation NOT Really a Conference Presentation? (NWBO)

Today is the big day. 4 June 2022. The date the retail cult around decades old bioturd, and current John M. Fife plaything, Northwest Biotherapeutics (NWBO) believe the company is “presenting” their “successful” Phase 3 data for their utterly useless dendritic cell vaccine for brain cancer (DC-Vax) at the American Society of Clinical Oncology (ASCO) Conference in Chicago.

Of course, just like all of their previously hyped appearances there is much less here than meets the eye.

Deluded longs, fed by social media scoundrels and relentless promotional campaigns, might believe NWBO is giving a legitimate presentation at the conference, invited because of scientific merit. However the reality is that Northwest Bio is not presenting at ASCO per se, rather the company is participating in something called the “Industry Expert Theater.”

So instead of being in the main hall, Northwest is shilling its wares (namely its share certs) back by the food court. The presentation is unofficial, unendorsed, and unaccredited. But what it IS, is bought-and-paid for advertorial nonsense. Unlike legitimate presentations where the speakers are invited by the organizers to share legitimate scientific breakthroughs and engage in legitimate scientific debate, IET presentations are bought and paid for bullshit. How much does it cost to hype your bullshit cancer quackery at ASCO?

Just $95,000 and you too can “present” at ASCO, just like NWBO! What a great use of stock promotion budget. One can read more about the IET here.

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

What Cytoklowning Was Revealed This Week? (CYDY)

Last week,  everybody’s favorite pink sheet reverse-merger Coronacrapper, Cytodyn (CYDY), began issuing a barrage of press releases (read about one here) culminating in one of their now-famous CONference calls, which you can watch here. In these calls, The NaDDiR* and his klown krew mumble incoherently, throw around tons of buzz words, and generally try to keep the suckers happy as the stock promotion lurches from one pivot to another.

On December 9, 2021, one of the Cytodyn press releases trumpeted the filing of an Expanded Access Protocol request by the company with the FDA, to allow for the use of loserlimab in HIV patients. Read it here. Expanded Access allows companies to offer unapproved drugs to patients outside of a clinical trial. Said the company:

Just five days later, on the December 14th CONference call, The NaDDiR* let this slip:

Ooops. A problem with the protocol. Did NaDDiR actually admit they “didn’t do a good job” with the submission? What could be the problem? The FDA accepts ~99% of EA submissions, so what are the reasons why the FDA would reject a submission for Expanded Access? That’s easy. The list is here:

If the curmudgeons at BuyersStrike! HQ had to guess, the FDA probably determined that either under part 2, Cytodyn was not actually pursuing marketing approval with appropriate diligence (ie the BLA submission was a pathetic joke) or part 3, there is not sufficient clinical evidence of effectiveness. Cytodyn only reports the results of one tiny Phase 3 study in HIV, and has offered no confirmatory evidence.

Just more of the endless Cytoklowning from the Klown Krew.

* Spelled Thusly For A Double Dose of That Sweet Sweet Stock Pimping

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

What Lemon Is Cytodyn Squeezing into Lemonade Today? (CYDY)

Starting yesterday, December 8th, everybody’s favorite pink sheet reverse-merger Coronacrapper, Cytodyn (CYDY), has issued a flurry of press releases. As always, it is important to read anything The NaDDiR* and his Klown Krew put out very carefully. Not just for what is said, but for what is unsaid.

One of the December 9th press releases, entitled “CytoDyn Submits Protocol with the FDA for Phase 3 Registrational Trial of Leronlimab for Critically Ill COVID-19 Population” has a classic NaDDiRism:

Of course, this is misleading because the FDA does not APPROVE trials. The FDA only ACCEPTS or REJECTS trial protocols. Legitimate companies that are not trying to hype their prospects to gullible investors use the proper language. Scams and cons, on the other hand?

But that is just routine Cytobullshit. The really interesting bit is this, where they excerpt some communications with the FDA, but fail to provide context:

For months now Cytodyn has been trying to restart the EIND/Expanded Access loserlimab for Covid program, or as we call it here at BuyersStrike! HQ, the perpetual anecdote machine. Naturally, Cytodyn has failed. It appears that back in August and again in November the company asked the agency to accept an Expanded Access program. Expanded Access allows patients to try an unapproved therapy outside of a clinical trial. The FDA has clearly said “no, you have to do a proper trial.”

While this is a flat out rejection, will the company and its shills try to pitch this as some sort of support from the FDA, instead of just a boilerplate rejection letter? After all, didn’t the FDA say the trial “appears feasible“, that has to be good, right?

Actually no, one of the criteria for the FDA to allow Expanded Access to a drug outside of a clinical trial, is that a clinical trial must not be feasible. By stating that running a trial is feasible, the agency is actually telling Cytodyn why their request for Expanded Access was denied.

While this is a flat out rejection, will the company and its shills try to pitch this as some sort of support from the FDA, instead of just a boilerplate rejection letter?

When the FDA gives CYDY lemons, of course The NaDDiR* will try to make lemonade!

* Spelled Thusly For A Double Dose of That Sweet Sweet Stock Pimping

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

Just What Country Hasn’t Cytodyn Mentioned In A While? (CYDY)

If you are anything like the curmudgeonly crew at BuyersStrike! HQ you probably try to keep a list, mental or otherwise, of all of the ridiculous claims made by everybody’s favorite pink sheet reverse-merger Coronacrapper, Cytodyn (CYDY). Oftentimes these exaggerated plans deal with very specific countries which seem to flit in and out of press releases with little rhyme or reason.

One of those countries, as you might remember from the Spring of 2021, is Canada. Don’t recall The NaDDiR* hyping up Canada as a potential EUA and even as a revenue source for loserlimab? Of course you do. Here’s a mention from an early March, 2021 webcast:

Not only will CYDY file for an Interim Order, the Canadian equivalent of an Emergency Use Authoriziation, but The NaDDiR* went as far as to suggest they might charge for loserlimab. This was quickly followed up in a conference call later in March:

So, as of March 23, 2021, the company has submitted a timeline to Health Canada, to start the Interim Order process. The NaDDir* gives an update about two weeks later:

Here he claims that on the 15th of April they will submit the necessary paperwork for the Interim Order, and again suggests they might be able to sell product in Canada.

On the 19th of April, Cytodyn announces that it has submitted part, and only part, of the Interim Order application. In a press release the company stated that the remaining sections would be submitted in the very near future:

Two or so weeks later, on another webcast, The NaDDiR* claims the submission could be finished by June, with a decision in July. Now he isn’t so sure they can sell loserlimab, but he promises to ask:

And since then, nothing but crickets from Cytodyn and its Klown Krew about getting an IO, let alone selling product, in Canada?

Dear readers, do you wonder why?

Surprising nobody with an IQ to the right of the median, the request for the Interim Order with Health Canada expired after six months because Cytodyn never completed the application for loserlimab! No actual complete submission was ever made. Sound familiar?

So what did the company actually submit to Health Canada?

See it all for yourself right here. The company knew at least by June 15, 2021 that they would not get an Interim Order from Health Canada, and that the clinical data to support any application would not actually be available until the very end of this year. Did The NaDDiR* ever tell you?

Or did he just pivot to the next country? Brazil? India? Philippines?

* Spelled Thusly For A Double Dose of That Sweet Sweet Stock Pimping

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

What Documents Did Cytodyn Never Want You to See? (CYDY)

Late yesterday, the 26th of October, one-time-NaDDiR*-favorite, Amarex, filed its response to the lawsuit (Case 8:21-cv-02533-PJM, see here.) initiated by everybody’s favorite pink sheet reverse-merger Coronacrapper, Cytodyn (CYDY).

Inside the filings are some bombshell documents that The NaDDiR* and his Klown Krew surely never wanted you to see. They most certainly did not want CYDY longs to read any of these before tomorrow’s vote to grant the company an additional 200mm authorized shares, along with insane compensation for insiders.

For a start, how about this insane April 14, 2020, email from the the NaDDiR* to Amarex’s Kush Dhody, in which The NaDDiR, obsessed with the stock price and message board criticism, instructs his Krew to knowingly file an incomplete BLA:

And sure enough the something resembling a BLA was filed, and the company proudly (and falsely) announced that the completed BLA was submitted on the 27th of April:

As we all know, this was a lie. Just over one week later the company backtracked, but hid the disclosure in the boilerplate at the bottom of a press release. Finally, on May 11, they fessed up:

Surprising nobody, except the deluded retail longs who comprise the CYDY shareholder base, the FDA issued a Refusal To File (RTF) letter. For almost a year, The NaDDiR* has, himself, refused to divulge the contents of the letter. Originally The NaDDiR* claimed the issue was just the syringes. If that was true, why is the RTF letter 20 pages long? But today you can read it for yourself. Some choice tidbits:

Ooops. Did the company even file the BLA under the proper pathway? Last time anyone at BuyersStrike! HQ checked, biologics aren’t approved under 505(b)(1) or (2).

Sterility testing? We don’t need no testing because loserlimab “saveZ teH livEz” (at least according to the shills and morons who believe), plus sterility testing takes money away from stock promotion:

Did The NaDDiR* write the “Prescribing Information” section himself?

There is so much more to see in this letter, but don’t take our word for it. Read it for yourself.

* Spelled Thusly For A Double Dose of That Sweet Sweet Stock Pimping

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

Re-Up From 2020: How Can Franklin J. Schaffner’s Masterpiece Help Investors?

[NB: An evergreen post originally from June 2020. The recent news about NKLA makes it more relevant than ever.]

From the 29th Scroll, 6th Verse:

“Beware the reverse merger, for it is the devil’s pawn. Alone among listed stocks it exists as shells, or SPACs, or zombie firms. Yea, it will jump on any trend to excite and possess the masses’ cash. Let them not list in great numbers, for they will make a mockery of exchanges and regulators. Shun them. Drive them back into their bucket shops lairs, for they are the harbingers of massive losses.”

Say it with us, “ALL Reverse Mergers Are Scams, In One Way or Another.

Re-Up From August 2020: WHAT IS CYTODYN (NOT)CURING NOW? A GUEST POST FROM B4UCONSENT (CYDY)

[Editors Note – The following is a guest post that originally appeared almost a year ago. It is about everyone’s favorite reverse-merger pink sheet Coronacrapper-turning-Cancercon, Cytodyn (CYDY) from @B4UConsent, a real life patient with tremendous insight into drug development from both the patient and the clinical trial management perspectives. Given this morning’s nonsensical press release from Cytodyn, it is timely to re-up her thoughts.]

BuyersStrike has generously invited me – patient, investor, blogger at B4UConsent – back to do a guest post on CytoDyn’s TNBC delusions. Happy to help!

Today we sink from the height of scientific rigor and strategic foresight we witnessed with Roche’s IMpassion program to the sewage ditch that is CytoDyn’s attempt to take on – wait for it – triple-negative breast cancer (TNBC). TNBC is, for the uninitiated, the rarest breast cancer subtype, exhibiting no hormone receptors nor overexpressing the HER2 protein, which make patients ineligible for anti-hormonal agents or HER2-targeted agents. Further, this tends to be an aggressive subtype that occurs in younger patients, and it’s associated with the poorest outcomes.

Historically, while TNBC patients have had few treatment options beyond chemo, there have been advances, particularly with immunotherapy. Roche received an accelerated approval for the combination of atezolizumab plus the chemo drug Abraxane, to be used in the first line. Sacituzumab govitecan, from Immunomedics (IMMU) more recently received accelerated approval in third line. Atezo/Abraxane is the standout here, and I have my reservations about sac gov, but there’s no disputing that these accelerated approvals were hard-won on PFS (progression free survival) data. Roche and Immunomedics are now just left to sweat out the wait on those OS (overall survival) numbers.

In contrast, CytoDyn got rid of a fake tumor engrafted on a mouse that one time.

And since in the fever dreams of its retail fanbase, and delusional (at best) management team, leronlimab has already “cured” COVID and HIV, with GvHD and NASH (and MS and Alzheimers, and on and on and on) on deck, why not throw TNBC in the mix? It’s not like it’s hard to design, recruit and run a cancer trial. CytoDyn is generously “keep[ing] the FDA current” on their miracle outcomes, which seem largely limited to meaningless, outdated lab markers (CTCs, really?) and not the more meaningful outcomes we in cancer are all familiar with, things like, “Tumor in lung got 31% smaller.” I’m sure our friends at the Agency are eagerly anticipating these updates and sending them straight to voicemail.

The most telling press release about the garbage this company is peddling is from January 13.

They reference two patients, one of whom is apparently enrolled in the company’s phase 1b/2 study which enrolls previously untreated metastatic breast cancer patients. You can tell a patient to drink more water in the first-line setting and get at least a modest response, which is why it should be a GCP violation to enroll subjects first-line for completely unproven drugs. You get one shot at first-line, one chance to maximize response and the duration of response. We know response rates get lower with each line of treatment.

In this case, the company felt compelled to announce that their first TNBC subject had a reduction in circulating tumor cells (CTCs). This is a) not an endpoint and b) not clinically relevant. No one does CTC tests, and they were never adopted widely because they were useless. They were never sensitive enough; you could be a walking tumor and have a CTC of 0. Plenty of metastatic patients have CTCs of 0, and a CTC result higher than 5 would signal full-on death watch. A more modern and useful marker would be ctDNA, which are small fragments of tumor that are used in the liquid biopsy tests we have from Guardant and Foundation Medicine.

Guess what else? “This patient’s data also demonstrated tumor shrinkage of >20% after just a few weeks of treatment.” Greater than 20%, that sounds good, right? It’s actually not. It means the disease has remained stable. In cancer, we use one guideline to interpret tumor size and response on scans: it’s called RECIST 1.1, and the rules are very clear. As a former medical writer on oncology trials, I can recite them in my sleep: a complete disappearance of disease is a Complete Response, or CR; reduction in disease >25% is a partial response, or PR; change in tumor measurement <25% but not increasing in size by more than 25% is defined as stable disease, which is NOT considered a response; and increase in tumor measurements by >25% is progressive disease, or PD.

So by the accepted laws of oncology, this patient is an SD. The CTCs are meaningless.

And what of the second patient?

She was not enrolled in a trial. She received treatment under an “emergency IND protocol” and is described as having “HER2+ metastatic, stage 4, MBC” and “showed no sign of new metastatic spots in the liver, lung and brain during the treatment with leronlimab.” Yeah, no new lesions is always nice, but what about the lesions she had at baseline? Subsequent press releases also suggest that this patient was receiving other treatment concurrently, so how could we attribute anything positive to the leronlimab?

This nonsense concludes with, “This strong data confirms the power of leronlimab as a CCR5 inhibitor for patients living with mTNBC, and is clearly replicating early animal study results that demonstrated 98% elimination of metastases.” (Emphasis mine.)

What’s that, now? That little mouse had what would probably be classed as a CR. These two patients didn’t even respond.

But why stop at TNBC when the data are so compelling? That’s a tiny little sliver of the cancer population. Aren’t there a lot more cancers to cure and patients, shareholders and innocent bystanders to manipulate?

That brings us to the basket trial, open to all solid tumors, which seems to have just started enrolling a few days ago. “All solid tumors” will apparently be represented in a 30-subject phase 2 at one site, something called “Quest Clinical Research” in San Francisco. Just the name evokes the echelons of scientific development, no?

Let’s review the primary endpoints for this “trial” together, shall we?

  1. Number, frequency, and severity of adverse events (AEs)
  2. Incidence of abnormal laboratory tests results
  3. Changes in Eastern Cooperative Oncology Group (ECOG) performance status from baseline to subsequent scheduled visits

Are 1 and 2 not the same? And … what is 3 supposed to demonstrate? That is not an endpoint for approval in oncology. The enrollment criteria specify an ECOG status of 0-1 (that’s fully active to slightly less active; by 2, patients are getting pretty debilitated). So we’re looking at a phase 2 with no PFS endpoint. This study is exposed as even more of a sham by a line in the study description section:

Subjects participating in this study will be allowed to receive/continue standard-of-care chemotherapy or radotherapy [sic] as per the dosing schedule included on the package insert.

Let me get this straight. Subjects have the option of staying on therapies that are already working and just adding an experimental agent. What exactly is being tested here? Who would enroll in something like this, and why would anyone let them? Are they trying to design a “study” that can’t fail by deliberately rejecting the efficacy and enrollment standards by which a whole industry abides?

Though we don’t have answers, we do have a lesson: stay away from this bioturd. At least the mouse made it out.

Thanks again to BuyersStrike for having me.

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

Taking A Victory Lap! (RCAR, WNDW)

Longtime readers of the blog will not be surprised to learn that recidivist Vancouver BC stock scammer Harmel Rayat is in the news again.

One might remember Harmel from 2018, when we looked closely at his two current stock promotions, Renovacare (RCAR) and Solarwindow Technologies (WNDW). Catch up on the backstory here.

Today, the SEC filed a complaint against Harmel alleging that he and the company attempted to hide their role in running a stock promotion scheme to inflate the price of RCAR shares, including issuing a press release, and filing an 8K with false information.

Perhaps most importantly the SEC alleges that Harmel tried to obscure the paid promotions by funneling the money through third parties. The SEC says:

Read the full complaint here.

A lot of other scams with supposedly no relationship with promotional outfits should take careful note. Insider Financial and Emerging Growth, we’re looking at you….

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

Quick Take: What Did Cytodyn Bury in Today’s Barrage of Press Releases? (CYDY)

Today is one of those special days in the saga of everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY). A day where The NaDDir* issued not one, not two, but three, ridiculous press releases seemingly devoid of substance.

But only seemingly.

Compare the boilerplate about Cytodyn’s ill-fated BLA re-submission for loserlimab in HIV from last week:

to the new boilerplate from today’s nonsense:

Oops. There it is, the one little bit of real information they tried to bury under a pile of bullshit. That pivot to a ridiculous cancer cure cannot come soon enough for the Klown Krew.

* Spelled Thusly For A Double Dose of That Sweet Sweet Stock Pimping

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

But Teh Science Be So Gud: Part 2 – Save Livez? (CYDY)

We have reached a repeat moment in the saga of everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY). The time when, after a study failure, the criminal stock promoters, various shills, and the retail shareholder base of complete morons suddenly become “experts” in “teh science”, results be damned. [Catch up on Part 1 of But Teh Science Be So Gud, from August 2020, here.]

After three morning press releases and then last afternoon’s delusional CONference call rantings from The NaDDir*, and his Klown Krew, yesterday the company issued an 8k with some (and only some) actual data from the failed CD12 study of leronlimab (lovingly referred to as loserlimab at BuyersStrike! HQ). The filing is available here.

The document is almost more noteworthy for what it doesn’t include, rather than the various post-hoc data dredged subgroups that it does include. Nowhere does it actually answer the question, “Does loserlimab actually save lives versus placebo?” Not mixed with a variety of other drugs, not when mixed with a variety of other drugs and dexamethasone, but does it actually do anything head to head against placebo? In order to answer that question one of our overworked interns volunteered to back out the numbers from the scant data that was provided.

Table 1-1 provides some mortality data overall for the mITT population. “mITT” is jargon for “modified intent-to-treat” and typically mITT is frowned upon, especially when the data from the ITT (without modification) population is not given. Nevertheless, it is all we have from the company. From this we learn that there were 259 patients in the loserlimab arm and 125 in the placebo arm. There were 53 deaths in the loserlimab arm (20.5% mortality), and 27 in the placebo arm (21.6% mortality). Although not given by Cytodyn, the difference is nowhere near statistically significant, the p-value is a whopping 0.79.

Many of these patients were taking all sorts of other therapies, and The NaDDir* is especially proud of one particular post-hoc subgroup analysis, patients who were on other prior or concomitant treatments:

The given p-value is actually suspect as the company admits “Note: p-value is from logistic model adjusted for stratification factor and age based on non-missing observed data.” A more standard calculation of the p-value would yield p=.167, which is still crap, but at least not p=.79 crap. Behold the power of post-hoc data mining.

But this chart still doesn’t tell us anything about the effects of loserlimab alone versus placebo alone. How did patients who were only taking loserlimab do versus those only taking placebo? Does leronlimab really save lives? Cytodyn does not provide the answer. But we will.

In order to answer that question, one needs to back out the 309 subjects above, those who took other treatments, from the 384 total subjects in the trial. Then we need to back out the 58 deaths in that group from the 80 deaths overall. That gives us 75 subjects (21 placebo, 54 loserlimab) and 22 deaths (3 placebo and 19 loserlimab). Plug those numbers into Excel, and presto, the answer to the question, “Does loserlimab actually save any lives?” is a resounding “NO.”:

35% of subjects receiving loserlimab alone died compared to only 14% of controls. The p-value happens to be 0.075, results that, as The NaDDir* would say are “Very Exciting!” and “Approaching Statistical Significance!” So much for “saving teh livez” with “teh science that be so gud!”

* Spelled Thusly For A Double Dose of That Sweet Sweet Stock Pimping

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.