Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
“Tamiflu (Oseltamivir Phosphate) market US$ 1.1 Bn in 2018”
Is’nt there a vaccine for flu for years?? Decades?? NO vaccine is close to eradicating any viral.
That is a fact. If Tamiflu has this market...Covid which is in line to become an endemic itself, and impacting the entire world will have tens of billions market.
And LL is the one and only drug to show any sort of efficacy.
Take this arm chair ceos!
https://www.biospace.com/article/tamiflu-oseltamivir-phosphate-market-companies-target-patients-with-renal-diseases-to-grow-in-global-market/
Million cases in a fortnight. 20k deaths New government taking charge in Jan. New FDA commisioner.
Enter New Life saving Drug LL!
Short squuuuuuuuue!
Sour grapes everywhere (“stop counting the votes i want win i am a cry baby” lol)!!!!!
Great informative post from other board-
So biggest things revealed on Today’s conference call are as follows
#1 statisticians have provided CD-12 data to FDA.
#2 OWS has been in discussions with CYDY and that EAU is on the table especially since FDA now has our data. Expectation is if we get EUA for CD-12 we should get OWS funding help and manufacturing.
#3 We also have a unnamed billionaire that if data shows reduces mortality he will personally step in and help with funding.
#4 Heavily focused on getting to 293 enrollment currently near 250, significant person Brian B. going around to many of the hospital sites to get us listed as priority.
#5 BLA is being worked on for U.K submission still seen as quickest path for approval
#6 Long Haulers FDA trial protocol being fine tuned to best position CYDY for future vital indications hopefully submit in a week or so.
#7 Canada meeting for HIV next week!
#8 Nash hope to enroll patients this year
#9 what lawsuits? Oh Bogus investigations what they are
Would like to see things like trial enrollment and BLA submission sped up more but overall very good call! Can’t wait for EUA to be announced out of nowhere any day now that FDA has our cd-12 inter data of 195. Remember FDA has states any drug that showed there maybe benefit that was more importantly safe could be approved for EUA. The saftey of leronlimab has never been in question and now that FDA is sitting on our cd-12 results and the fact DSMB continued trial with no recommended changes put us in what I think should be 99.9% EUA provided there’s plenty of data to support efficiency and safety. Looks like all the pieces finally coming together. “Don’t Blink”
“ Management will provide an update on recent clinical and regulatory developments regarding COVID-19 and other indications for leronlimab.”
Also the worlds most important election is happening rightnow. Most companies have released their ER last week so the sp would not
Inadvertantly suffer as a result of releasing a pr or er along with the the election results.
Also, this year np has always given at least 2 business days anyway between announcing a cc and the actual CC. Perhaps he wants to give the shareholders sufficient notice. Perhaps he likes to release the pr as soon as the news comes in and then await more details until the day of the cc. But again this is election day so no one should expect a pr tue or wed. Common sense.
Naydenov Jordan G is piling it up! He bought 200,000 shares again yesterday!
Again Timing! Shorts are now screwed unless they cover tomorrow.
I predict Dr Rahman will announce a BLA related progress, filing or something very significant.
Np will announce clinical trial updates, incl commencing long hauler trial perhaps
Bottom line UK is getting hammered again. Would not be shocked to hear them say UK is very interested in Covid s2c results (75%) or even eua in UK
15,000 ppl have died in the US alone since our intermin analysis results.
In an ideal and fair world perhaps most of these ppl would have gotten LL and not died.
Sucks.
Not really.
No one is expecting any Sort of update for now.
Fact that he wants to give an update alongside DR Rahman is clear indication the update is of significance and positive
Clinical update would be thAt we are probably less than 20-30 away from 75%
Regulatory update would be about UK BLA HIV filing and perhaps UK and philipino approach for m2m and interim s2c patients
“ Management will provide an update on recent clinical and regulatory developments regarding COVID-19 and other indications for leronlimab.”
Cant wait for the SHORT SQQQUEEZE!
Something is coming!
I wrote to Richard harris at npr in response to his Eli Lilly article.
He promptly responded as below and i responded with some Cytodyn’s major milestones.
Not sure he wiill take this up but some of the longs can try to write to him if you think fit:
I wrote”
Thanks Richard! Absolutely!
Here is the link to their dsmc assesment of their recent ph 3 interim analysis for efficacy of severe to critical covid patients:
https://www.cytodyn.com/investors/news-events/press-releases/detail/477/cytodyn-receives-positive-dsmc-recommendation-after-interim
Safety:
https://www.cytodyn.com/investors/news-events/press-releases/detail/456/cytodyn-receives-positive-dsmc-recommendation-for
Here is the link to their positive results of phase 2 of mild to moderate patients:
https://www.cytodyn.com/investors/news-events/press-releases/detail/458/cytodyn-announces-clinically-significant-top-line-results
https://www.cytodyn.com/investors/news-events/press-releases/detail/462/cytodyn-requests-fast-track-approval-for-covid-19
https://www.cytodyn.com/investors/news-events/press-releases/detail/472/cytodyns-phase-2-study-of-leronlimab-for
I appreciate your work in this time of need!
Please let me know if you have more questions.
Thanks!
“
Harris <RHarris@npr.org> wrote:
I generally consider covering drugs when they have positive phase 2/3 results and/or get EUA. Feel free to let me know about truly major milestones.
Richard
?On 10/28/20, 11:42 PM, I wrote:
Mr Harris, in response to your article on the Eli Lilly Anti body drug, i would ask you to cover a company called Cytodyn which is the first company to have its drug Leronlimab -another monoclonal antibody get a safety and efficacy positive recommendation from the Data Safety Monitoring Commitee (DSMC) for it ‘s phase 3 severe covid patients on interim
Analysis. Being a small
Company it hardly gets any attention.
Appreciate your help!
Mukund
Sent from my iPhone
Analysis: CytoDyn's lead asset leronlimab is set to be a major player in the CCR5 inhibitors/antagonist market. The company has a market capitalization of $1.38 billion on a stock price of $2.42, which is in the lower quadrant of the 52-week range from $0.26 to $10.01. Over 86% of the 571 million outstanding shares are held by the public, while institutions, corporations and insiders hold 4%, 3.7% and 5.68% shares respectively. CytoDyn has a debt of $32.4 million, and cash burn in the TTM has been $87.6 million, whereas cash balance is very low at $18.20 million.
Investment Thesis: While CytoDyn is deriving synergies by developing its lead candidate Leronlimab for different indications, its COVID-19 program is also expected to yield positive results.
Seeking Alpha
New Delhi: The Oxford University's Covishield vaccine for coronavirus has drawn an immune response even in the elderly, who are among the groups vulnerable to the disease, Adar Poonawala, the chief of Serum Institute of India, which is partnering the UK-based premier university, told NDTV today. The vaccine, he said, is "very safe". "Thousands of people have had it in India and abroad so we are cracking on track with no safety concerns," he added.
"It does give an immune response which is good news. You know we were always fearful that whether it will protect the elderly as well, that was our concern. So, you know it will give a slightly different response but it seems at the moment we're going to get a response both in the young and healthy, and the elderly," Mr
While underscoring the safety of the vaccine, Mr Poonawalla however, said it would take time, nearly around two years, to come to a conclusion about its efficacy.
"It's only after a year or two that we see vaccinated patients or people whatever, be protected when they are exposed to the virus that we will know the vaccine has given you that long term immunity," he told NDTV.
Arm chair ceos paid $10 an hour lol commenting on cydy lollllll
Next Catalyst- Cydy finishes enrollment of the 63 patients for s2c cov in 2 weeks
There you go as expected the PR that will go down in history
Suck it bears and arm chair ceos! Lol!
Mark my words nasdaq listing in a month coming
"Insiders might sell their shares for any number of reasons, but they buy them for only one: they think the price will rise"
- Peter Lynch
“
In early 2002, Dr. Rahman joined Centocor/Johnson & Johnson and was involved in the development of Infliximab, golimumab, ustekinumab and several small molecules as the Rheumatology Clinical Team Leader. “
“FDA requests unblinded S2C data!”
Tonight/Tomm PR lol
Expecting PR either in the next few mins or 6 am eastern like always
What will be the PR? Highly speculating to be FDA unblinded S2C data!
Cydy -dsmc says continue trial aka you benefit covid
Eli lilly - dsmc says stop trial aham no benefit to covid
Mic drop
Jordan G Naydenov is listed as an insider in the following companies: CYDY / CytoDyn Inc. Insiders are officers, directors, or significant investors in a company. It is illegal for insiders to make trades in their companies based on specific, non-public information. This does not mean it is illegal for them to make any trades in their own companies. However, they must report all trades to the SEC via a Form 4. Despite these restrictions, academic research suggests that insiders - in general - tend to outperform the market in their own companies.
Holdings
Security Title Post Shares
CYDY / CytoDyn Inc. Director 6,257,823
120,000 shares “Purchased “ at this stage.
Great sign!!!! For us knowing an independent director thinks this is agreat time to buy!
Man already has more than 6 million shares!!
Thank god he did not listen to
The arm
Chair CEOs here!lol!
BOD buying darn i shud have bought today...Big PR on UK coming
LL-the only drug to have approvL from dsmc esp at the ph3 trial:
Coronavirus clinical trials are pausing over safety concerns – what that means
https://www.cnbc.com/2020/10/15/coronavirus-clinical-trials-are-pausing-over-safety-concerns-heres-what-that-means.htm
Dr Mahboob Rahman ‘s impressive profile includes working for several
BPs for several years..16 BLAs , succesful FDA approvals before he decided to join the next big big bp!
Thk god he did not listen to the arm chair CEOs on this board ! :)
Global head Glenmark
Vp Novartis
Vp Pfizer
Senior Director J and J
About our chief scientific officer Mr Rahman
“In 2013, he joined Novartis as a Vice President and the Therapeutic Area Head for Immunology and Musculoskeletal Disease, where he was involved in the development of several compounds of which two achieved FDA and EMA approval for marketing, Canakinumab and secukinumab in several indications. I”
Kaboom!
Results
Mean age was 69.5±14.9 years. 20/23 had significant co-morbidities. At baseline, 22/23 were receiving supplemental oxygen (3/23 high flow, 7/23 mechanical ventilation). Blood showed markedly elevated inflammatory markers (ferritin, D-dimer, C-reactive protein) and elevated neutrophil:lymphocyte ratio. By day 30 after initial dosing, 17/23 were recovered, 2/23 were still hospitalized, and 4/23 had died. Of the 7 intubated at baseline, 4/7 were fully recovered off oxygen, 2/7 were still hospitalized, and 1/7 had died.
Conclusions
Leronlimab appeared safe and well tolerated. The high recovery rate suggested benefit, and those with lower inflammatory markers had better outcomes. Some but not all patients appeared to have dramatic clinical responses, indicating that unknown factors may determine responsiveness to leronlimab. Routine inflammatory and cel
Minimim days to FDA glory: 10-15
Fda could look at unblinded data after election results
Fda could want the unblind this week after yesterday’s all time high covid cases
And market sell off today
Fda could get an epiphany and sense that number of deaths is climbing steadily and no remdesvir does not work
(Daah)
Maximum days to
FDA Glory: 100 days
Even if cydy enrolls one patient per day,63 days plus 42 days and already started last week, the enrollment
DO NOT even need to mention about UK and other counties
Covid Hiv and cancer and others
Np will be hailed as best ceo 2020 when a bp makes a “three digit” offer.
Ps: please no jokes on the three digit and decimals kids this aint 1950 lol
Covid 19 becomes an endemic we need all the LL in the world esp if a vaccine would not be everyones choice and
May not be more than 50% efficacious
Total number of shareholders 15x since last year . No question . Number of shareholders has only grown this year. Period.
Intra day and week stop loss traders and shorties aint real investors np or anyof us are concerned about.
We have a high profile chief scientific officer. Moving forward. Read beween the lines in the proactiv video.
The least paid employee in cytodyn is probably more smarter than this board’s smartest shorties. Who do u trust!
With the president touting for remdesvir it makes sense to not push the envelope now. It will all happen after the election and 75% intermin results are out.
Any news on Fox business will be taken slightly skeptically because of what has transpired with plasma and truthfully remdesvir. So, it will take new investors a little bit of time to do their DD before considering Cydy.
What they and we should all consider honestly is some bp is taking a note talking to us for sure.
This is the best time before the election to make a move. Once the 75% analysis is done the ship will have sailed for bp and we may not be affordable to them! We probably are not anyway even now!
On it already
TRUE! The headline kept at it “ Cytodyn receives late stage approval from dsmb”!
Np repeated that “no other company as any sort of mortality approval” !
Np also said we are the “safest” drug to have any mortality approval. Hopefully all this reaches the mass.
Rest of This week will be a test of what REAL SAVVY investors who know small pharma stocks buy into!
Np cant get it right can he? You would rather hear that we hav potential to become $20 stock ? Lol
We have invested in this company. This is his job to keep us interested and invested!
Thats all you got lol we must be doing pretty well then!