Exposing Pump and Dumps - All my own opinions / not financial advice
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Critical Placebo Mortality Rate of 29.9%
Relief Trial Data
See here
Remember this was only CRITICAL patients, while CYDY is a mix of critical and severe
Why are you even bothering pumping the stock?! In order for Leronlimab to have p-value < 0.05, and be approved, placebo mortality rate needs to be >31%. This trial just proved what KGRO and JUSTDA have been saying, it is impossible to get >31% given most recent trial results in critical and severe studies.
GAME OVER GOOD LUCK WITH THE HIV BLA (which is only worth about $50mm if you get it or $0.10 PPS)
Updated Clinical Trial Analysis
Veru just reported its phase II (N=38) in hospitalized patients
18 took Veru pill and 1 died (5.6% death rate)
20 took placebo and 6 died (30% death rate)
If you think Leronlimab will have a similar results, you are sorely mistaken. The interim of n=195 had a total deaths of 45, in which approximately:
131 received Leronlimab
64 received placebo
If the interim results looked like Veru's, total deaths would have been 26-27 (13%) , not 45 (23%)
131 * 5.6% = 7
64 * 30% = 19
Seems like CD12 results are being delayed for a reason ;)
How much clearer could it be?
CD12 data being withheld intentionally - The primary is 28-days, it would take 20 minutes to clean and calculate the p-value.
Tons of paid pumps coming out - Proactive (pulled the video), Dr Randy (owns shares), Blue Cool (paid promo), Zerohedge Chessmaster (paid promo).
This youtube video operating under the guise of "CDC"
The desperate reddit thread that is getting no traction...
C'mon, man
Hysterical YouTube Pump
The Philippines Youtube pump was so full of cherry picked data. It was so clear this was a pump in order for Blue Cool to Dump.
Anti-vaxxers
HCQ pushers?
Long hooolers?
HAHAHAHAHAHAHAHAHAHAHA
That’s called 10 days to cover, which is mid range for a biotech stock. Also how many shares does Fife have? How much more menimelll delutiennn just happened with warrants? The float is increasing like 200mm a year from structured financings.
How can you possibly think that there’s naked short selling going on when only 30mm of the 600mm shares are shorted? That’s 5% of shares outstanding being shorted. The avg biotech has about 12% of the shares outstanding shorted making this OTC pump and dump one of the least shorted biotechs as defined by % of SO shorted.
It was most likely Fife selling his lawsuit reward shares. The filings line up such that this is the most likely scenario. Tim said he went LONG!
They had to say CSP bc even their pump video said they cannot get EUA in Philippines without receiving it first in the US. It’s like Nadder is trolling the adults in the room for fun while the baggies scream “to the moon” on WSB Reddit subgroups...
BC these data are a dumpster fire
Menimel Delusion
On January 28, 2021, CytoDyn Inc. (the “Company”) entered into Warrant Exercise Inducement Agreements (the “Exercise Agreements”) with certain substantial holders of outstanding warrants (“Exercise Warrants”) to purchase an aggregate of 3,560,550 shares of Common Stock (the “Warrant Shares”). The Exercise Warrants had exercise prices ranging from $0.45 to $0.75 per share and were issued in various financing transactions between November 2017 and December 2019, expiring five years from their respective dates of issuance.
Pursuant to the Exercise Agreements, as an inducement to exercise the Exercise Warrants immediately for cash, the Company and the holders agreed to negotiated exercise prices ranging from $0.90 to $1.50 per share, and the Company agreed to issue to each Exercise Warrant holder upon exercise an additional four-tenths of a share of Common Stock (collectively, the “Additional Shares”) for each share of Common Stock underlying the Exercise Warrants. In the aggregate, 3,560,550 shares of Common Stock, which includes the 2,543,250 Warrant Shares and 1,017,300 Additional Shares, will be issued in these transactions for aggregate gross proceeds to the Company of approximately $2.9 million, less expenses and the cash fee payable to Paulson Investment Company, LLC (“Paulson”), described below. Final settlements closed on January 28, 2021.
In connection with the Exercise Agreements, the Company entered into a Soliciting Agent Agreement with Paulson, pursuant to which Paulson assisted the Company as its exclusive soliciting agent in connection with the exercise of the Exercise Warrants. Company will pay to Paulson, as compensation for the services provided, a cash commission equal to four and one-half percent (4.5%) of the gross proceeds received by the Company from the Exercise Agreements.
CD 10 was the trial $CYDY failed for mild to moderate COVID, which resulted in the FDA rejected EUA and removing the eIND
He said triple digits before releasing CD10 data. Remember that trial? The one that failed and resulted in losing the eIND? Right
Conservatively worth more than Regeneron is definitely conservative lol
$1 still is $600mm mkt cap, assuming 600mm S/O which is on its way to 1B shares outstanding with ratchets and continued need for financing. I would expect this company to have a $50mm enterprise value, on 1B shares or $0.05 PPS.
Whereas, Bruce Patterson, Nader, Mahboob, Proactive Investors, Tom Landstreet, Emerging Growth (Lankford), have credibility?
They’re too busy settling with Alpha Ventures and Pestell to care about some guy exposing their scam
Which is why they will get other treatments and not Leronlimab. Bc Leronlimab doesn’t do anything
CD12 PR Results = CD10 PR Results
Great Results!
We met a random subgroup secondary endpoint
Fantastic Results
**MISSING PRIMARY ENDPOINT DATA**
Looking forward to our discussions with the FDA
FDA rejects EUA and removes eIND
Speaking with Mexico and Philippines tho!
I hope everyone knows that people like Thomas Landstreet, Samantha Mottet, and Chris Reckor can go to the media with opinions, which are factually incorrect. Sometimes it results in the articles being removed from websites like Forbes, WSJ, ect.
Right but almost every other COVID player has gotten at least an institutional investor and almost all legitimate companies have a BP partnership. So why can Leronlimab only get SEC charges securities fraudsters like Fife to finance the business?
Hint: it’s not bc retail is smarter than buyside.
Out of 600mm shares outstanding. Which makes cydy one of the least shorted biotech stocks, as a % of S/O. But tell me again about all this “naked” short selling
Let's not argue the semantics of the % of M/M patients in a hospitalized trial (albeit a diagnosis of M/M would very likely be changed to severe if hospitalized). If one looks at the inclusion criteria for ANOTHER convalescent plasma trial with Cytodyn's CD12, they are very similar.
What were the NEJM (not pay-to-play) published results of the CD12-esque trial for convalescent plasma (not company touted)?
11% mortality rate. If you ascribe 11% to JUST the severe cohort you would some of the highest critical death rates ever recorded (although Cytodyn's CD12 trial excludes the sickest) to have a 31% mortality rate in placebo.
https://www.nejm.org/doi/full/10.1056/NEJMoa2031304
This is pretty simple math:
Here a very large sample size was taken (10k) for hospitalized patients (same as CD12 trial)
https://clinicaltrials.gov/ct2/show/NCT04381936
The results were 18% mortality rate
https://www.recoverytrial.net/news/statement-from-the-recovery-trial-chief-investigators-15-january-2021-recovery-trial-closes-recruitment-to-convalescent-plasma-treatment-for-patients-hospitalised-with-covid-19
In order for Leronlimab to achieve a p-value <0.05, on 90 deaths, they need placebo mortality rate to be over 31%. Even emerginggrowth website agrees with analysis
https://emerginggrowth.com/cytodyn-update-reveals-q1-sales-pipeline-philippine-eua-nasdaq-uplisting-high-likelihood-of-approval/
It seems improbably for that to be the case given Leronlimab excludes the sickest from its trial (look in exclusions)
https://clinicaltrials.gov/ct2/show/NCT04347239?cond=leronlimab&draw=2&rank=6
Anything is possible but this seems highly improbable.
10k shares of $50k of volume. It’s not real
Right on N=10k 18%
10,500 hospitalized with 18% death rate
No, in general. What do people think the hospitalized death rate is for COVID19
Question: What is death rate for hospitalized COVID patients?
Why CD12 cannot achieve p-value < 0.05
Before I begin, please familiarize yourself with these two studies
CYDY CD 12
tocilizumab and sarilumab Study
How can Leronlimab acheive p-value <0.05
With 90 deaths (they listed 87 but to be safe let's say 90 bc there was still ~10 days of trail left) the placebo group needs to have a death rate over 31% (even Joshua Lankford of Emerging has 90 deaths and agrees).
Trial Designs
CYDY was for severe and critical patients. The salient distinction is severe patients are not vented while critical patients are. Also worth nothing, the most critical patients do not fall within this range: "Subject, if intubated, positive endexpiratory pressure (PEEP) <15 cmH2O with PaO2/FiO2 >150 mmHg" and Cytodyn excluded that group for its study
Toci and Sari results
Toci and Sari placebo group had a mortality rate of 36%. Although above 31% necessary, remember this was for the critical, vented, cohort only. Cytodyn will have, most likely, half of the study be severe, which is showing mortality rates of about 10%
Why placebo group can't be >31% death rate
The study, would have been halted for efficacy and Leronlimab would have been approved as current standard of care. The fact that it wasn't means that it is improbable that the placebo group will have >31% death rate while overall death rate is 23%
S/C will tail like M/M
HIV BLA submission probably happens but that market is very small and there are numerous drugs including this new GILD drug that is Sub-q
https://www.gilead.com/news-and-press/press-room/press-releases/2020/11/gilead-announces-investigational-longacting-hiv1-capsid-inhibitor-lenacapavir-achieves-primary-endpoint-in-phase-23-study-in-heavily-treatmentex
Even if they get the BLA approved its a $50mm end market and the current EV is $1.5B.. If they become successful in HIV the company EV should be $100mm or so which makes this stock about $0.10
Manuscript Findings
1) There is nothing to do here bc it isn;t a controlled trial
2) It is only 23 patients
3) "Routine inflammatory and cell prognostic markers did not markedly change immediately after treatment"
4) Mortality rates at 17% were higher than both Remdesivir severe-to-critical and placebo in Gilead's most recent trial (below), which were 15% and 13%, respectively. Only 1 patient got Remdesivir in this trial
Redemsivir Trial
5) That is a long list of conflicts of interest
6) Where is the CD10 manuscript? This is taking a very long time
From the same area as the Nadder? Ruh Roh
https://www.linkedin.com/in/antonio-migliarese-a2ba668/
Per 8k: N=195 / Death = 45 / Mortality = 23%
Nader update said over 50 deaths with N of 220 which gives mortality ranges from 23-27%, but let's ignore that bc, at this point, its moot
LL:Placebo/SOC 2:1
So for n of 195: 130:65 LL:Placebo/SOC
Most recent placebo severe to critical mortality rates range from 13 (Remdesivir trial) to 26% (HCQ trial) to 28% (Emory).
So let's use the 8k of n=195/D=45
Placebo let's say 27.5% death rate to give upper bound range of recent trials
Placebo/SOC is 18 deaths (18/65=27.5%)
LL is 27 deaths (45-18=27)
That is a p-value of 0.15, which is not close to stat sig
In order for Leronlimab to have a 0.0045 P value they will need to have a mortality rate in the placebo trial of over 35%. That seems very very unlikely.
Correct especially bc CYDY is having real issues with enrollment. They are only enrolling about 5 per week, with still no EU sites. At this rate of 5 per week, it will take them another 30+ weeks to fill enrollment and we won't get the data readout until Jun 21' well after a vaccine is around
Well to be fair $CYDY has only had this magical PRO140 in its possession for ~15yrs. They have more RFTs than approved indications!
Where are the EU sites btw? Nader said on DrBeen (9/22) that EU sites will be enrolling shortly and that was almost three weeks ago! He also said they were at "roughly 220" enrolled then said 220 enrolled on 9/30. I wonder where they are now? At this rate maybe they finish enrollment by YE 2021?
Special Kinda Dumb
1) DSMB will not approve EUA based on a hunch. FDA already rejected EUA based on CD10 trial results. Just like MHRA rejected fast-track based on CD10 (still no EU sites for CD12 btw)
2) Of Nader unblinds the data and takes the penalty, in order for it to have a p-value <0.045 the placebo death rate will need to be over 35%, which is extremely unlikely. If it doesn't have a better than 0.045 P-value this comment is moot bc the drug sucks
214-220 DrBeen on 9/22
[url]
Anyone know the latest enrollment number?
Nader said 220 on 9/30 during the presentation. Anyone have a more updated number?
Efficacy? What efficacy? They failed CD10, EUA rejected by FDA, MHRA rejected fast track, still no active trial sites in EU, lost eIND, Yale dropped out of trial site, and looks like they already failed CD12. Anyone know what the enrollment count currently is? And what enrollment count was two weeks ago?
You cannot get uplisted without raising equity and Iliad will crush the stock with its full ratchet if you raise equity below 4.5 let alone 10.
They disclosed yday that they’re running out of cash and cannot conduct any trials without raising more money
CD10 was an abject failure
US HIV BLA he punted on timeline and said MHRA looks promising (new shiny distraction) even tho MHRA rejected them for Covid fast track
Nader basically admitted COVID indication is not going to ever be approved. So if you’re in the stock for COVID you’re living in a prayer. If you’re in it for HIV, that market is tiny and at most that gives an EV of $100-$200mm with the mkt cap today at $2B (90% downside) + Fife will kill equity holders with his ratchet