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I'm spinning here as well, Dr. Rock, this sounds like one of those "too good to be true" scenarios that wise and prudent people warn us about.
But a man can hope and pray, so until proven otherwise, here's hoping and praying for some CYDY thunder shaking the White House tomorrow night,
Sleep well!!!
So Dr Rock and Dr Mis and anyone else - what other drug besides Leronlimab could the White House be speaking about? Wouldn't we already be aware of another drug? I mean, these therapeutics just don't pop out of nowhere, right?
Best guess, Doctors: Could it be any other drug besides Leronlimab??
Question, MissedSTEMI: If the FDA does not decide in our favor, is there any kind of emergency appeal process? Any other recourse?
For the life of me, I can't see how - compared to other current alternatives - how our safety/efficacy results don't make us a slam dunk for immediate approval.
And if there is no appeal process, there should be. No bureaucracy composed of people who can't be prosecuted or fired should have absolute power in life/death situations. Every system needs positive/negative repercussions or it ceases to be responsible and responsive.
So, which is more baffling: the current share price of a supposedly "eco-friendly" car company that produces vehicles primarily powered by coal and highly toxic rare earth elements (TSLA, $1554/share) - or the current share price of a company that makes the only clinically proven therapeutic treatment for a virus (and perhaps HIV, various cancers, and etc) that has hobbled the world's economy and claimed nearly a million lives (CYDY, $4.10/share)?
I used to think the stock market was a place for considered opinion and rational thought because people were investing their hard-earned cash.
Instead, much of the market seems to reflect the worst tendencies of human nature: emotional, irrational, short-sighted, and easily manipulated.
The fruits of greed, perhaps.
Or maybe just another random walk down Wall Street.
Bottom line, I see no scientific or moral/ethical reason to deny Leronlimab to humanity for even one more day: it's been proven 100% safe and it's the only damn thing that works!
"Frank" on the yahoo board just posted this, it's an excellent summary of why this week (and future weeks) hold such great promise for both the sick and those who are waytoodeep invested, like me, in CYDY:
"Everybody who has at least some limited knowledge and experience on how the FDA, the EMA (European Medicine Agency), the British or other drug authorities assess medicines know how at the end the decision is made:
it is based on a RISK (possible side effects) versus (clinical) BENFIT analysis. And this assessment takes also into account the risk-benefit of existing drugs against the disease and the disease itself. For example: if there is no or little effective treatment against a certain cancer: then a drug which offers some benefit may also be accepted despite severe side effects (as we all know for most of the anti- cancer drugs). If there is already an effective drug with little side effects, then a new drug should not have a worse risk (= side effects) - benefit (=efficacy) profile.
Now leronlimab:
1) Safety first: we have more than 800 patients from the phase III HIV trial, plus the perfect safety from the M&M trial. And also the DSMC review on the ongoing S/C phase 2b/3 (phase III !) Trial confirmed: zero safety issue for leronlimab. Cannot be any better.
2) Now the second element: efficacy:
In the M/M trial we had less than half of the adverse events of the placebo group - statistically significant (p< 0.05) Placebo is water, inert without any effect. Now if anything is reducing adverse events by more than half that means that it must have an effect, by either strengthening the immune system or any other effect that is strengthening the overall health to make the body more resistent to adverse events (adverse events include also events caused by the virus, e.g. required ventilation, cardiac failure, kidney failure, thrombosis, stroke....). It is true: normally this endpoint „adverse events“ are put to the safety section of the dossier, BUT: normally „adverse events“ are never reduced by drug“ (rather increased by the drugs side effects). That is why it is normally in section“safety“. Somebody said in more than 300 trials he had conducted he never saw such reduction. I did not conduct any clinical trial, but I have assessed an even higher number of clinical trials for the drug authority of an European Member State and the European Medicine Agency. I also cannot recall any such result. The only logic explanation is that the drug is efficient. It works. Other elements for the efficacy assessment: ideally also one or another endpoint (primary or secondary does not matter here in Covid - see Remdesivir approval) is positive or at least show non-statistically improved or better figures as compared to placebo. A lot of scientific weight is also given to the mode of action. Is it plausible? Has it been shown (changes in cytokines, T-helper cells, viral load in the blood? - Ideally in those patients which shown also clinical improvement. That would be also strong evidence for the efficacy of a new drug. I am confident that this is shown for leronlimab.
And finally the 54 IND patients from the uncontrolled trial will also be considered. Alone it would not be enough - but such data is usually considered „supportive“.
At the end the FDA, EMA, the British and other authorities will do this risk-benefit analysis. Risk of leronlimab is almost if not totally zero. For the benefit we have some strong evidence from the clinical trials supported by a reasonable mode of action and the 54 IND patients.
The last step is then the FDA and other drug authorities will compare that with the approved therapies: we have very little here:
Remdesivir: Little if any effect on a minor secondary endpoint, and side effects on liver and kidney. Theoretical mode of action (antiviral) but could not reduce viral load in COVID patients.
Dexamethason (strong cortison with all the side effect of cortison including immunosupression. We do not need an „Atombombe“ immunosupression here, we need a targeted effect on the immune system to calm the devastating cytokine storm.
FDA, EMA etc will consider all the above in much more detailed way, but eventually there is only one outcome here: approval of leronlimab.
BTW: the same applies for HIV where we even have the full phase III data (non-pandemie Standard). Leronlimab is by far better than all other current anti-HIV drugs. It will be the new standard. Now you know why I invest in leronlimab (CYDY)."
Rockleo, I always enjoy reading your posts, they strike me as both balanced and insightful. I think your analysis of the hydroxycholoquine fiasco in the US is spot on - i.e., because President Trump mentioned it, the treatment was mocked/ridiculed/shelved entirely due to left-wing politics- and I hope the same does not happen with LL if our Pres announces/supports it as well.
Also really enjoyed reading about your connections to the Indian Army, I hope they prevail against the Communist Chinese up in the mountains. I read about the bloody battle just fought above 14,000 feet, and it sounds like India's troops shocked the Chi Coms with their courage and ferocity. Can't imagine fighting for your life at the roof of the world, pretty surreal.
God Bless you and your work, and thanks again for all your posts!
Great post, Jackets! Been here only since March/April, but you’re right: from all I’ve seen and read so far, Leronlimab is not just a jewel, it is the rarest of gems because it has no safety issues or negative side effects. Amazing. I just got off the phone with fidelity to move my CYDY into a Roth, but when I heard what the short term tax hit would be, I decided to stay traditional IRA for now. Good Luck to you and to all longs, let’s hope tomorrow will be explosive in the best possible way!
Latane, I had you pegged for a bio-industry guy, perhaps a professor. Just goes to show, you never really knew who might step out of a Sherpa.
Hope you're still flying, God Bless and Good Luck!
Hello, Nursetrader, I'm a new investor as of Monday @ $4.75 (and yesterday at $3.10).
So first, thanks for your posts, I'm learning a lot. And second, I'm usually a buy-and-hold investor, so - with NEXCF, I'm curious: do you have your sell price levels already mapped out? Like most investors, I buy something because I believe in it's potential, and I find it very hard to make a short-term profit...knowing that, with such a volatile stock such as this, that the price could shoot up as soon as I hit "Sell."
In short, do you have your specific exit SP levels already planned? Or do you just go by feel/momentum.
Thanks again and good luck!
Outstanding summary, Latane, I nominate you as CYDY's "Clarity and Big Word Simplification Officer."
Carry on!
Thanks for the link, Zeuss! I'm just now reading about today's PR, I was looking for some actual "bad news" to justify the sell-off.
Well, not only is there no bad news, this safety data looks FANTASTIC!
From your linked article,
"These results earn leronlimab exceptionally high marks with respect to safety, but should come as no surprise because over 750 HIV patients have taken the drug without any safety issues. In the coming days or weeks the company plans on following up with the efficacy part of the trial and reveals whether or not it met its primary endpoint of clinical improvement assessed on a 12 point scale. The reason for optimism that leronlimab will crush its primary endpoint lies in the huge statistical reduction in SAEs. Scott Kelly, M.D., CytoDyn’s Chief Medical Officer, commented,
“We believe the significant reduction in SAEs in the leronlimab group ultimately translates into improved patient clinical outcomes."
Success!!!!
SP to follow.
Agree, Crcook, it's been a long ride since first boarding the MSBT train.
2Q revs could have been better, but it sounds like we're playing some offense with the 40M offering, let's see how things look by Dec.
Train keeps a rollin' and we're picking up steam, hang on!
Hello, BreezeWoodAcres, thanks for your nice summary. I'm a new investor as of today. I heard about this stock on Friday after market close, and when I saw their 3-d augmented reality demo, I was amazed. So here I am, and I look forward to learning much more about NexTech in the coming weeks; this is one of those tech "story stocks" that could really catch fire.
In short, seeing is believing!
Thinking the same thing, but - looking at the timing of this application (I know it's been in the works for months/years), would this be yet another indication that they just now (today) found out the results of the COVID trial(s)...and since everything looked good, they saw no reason to delay?
In other words, is this after hours PR announcement yet another confirmation of good/imminent COVID results?
Not a real fan of "coincidence."
Black Ops and Saltz and other CYDY cowboys -
Regardless of how our COVID data release goes in the coming days and weeks, thanks in advance for both replying to my posted questions and for all the great info and background color you've provided. CYDY has not been like any other stock I've invested in, the excitement has been at near-fever pitch since I found out about CYDY back in March.
It's been a fun ride, and if we actually have a bullet that works against the Chinese Communist Party's viral gift to the world, the ride will have just begun.
So with a nod to Alan Shepherd, let's light this candle!
Correct me if I'm wrong, but -
The way I see it, we now have three very positive INDIRECT indications that suggest we're in for some positive COVID clinical test results:
1. The tone and body language of all the principal management and scientific leaders at CYDY have been brimming with enthusiasm for months.
2. The recent manufacturing/distribution agreement: Unless management had REAL SOLID indications of our effectiveness against COVID 19, why would they spend all the time/money on this recent agreement?
3. Today's FDA wiffleball request for needle info: Because if the FDA really wanted to slow us down, wouldn't they have tried to shoot some deeper, more lethal holes into our science or trials?
In short, by some major indirect evidence, I think we have a product with NO deleterious side effects that will shock the world with its efficacy against COVID 19.
Approaching target, standby for BOOM!
Shockwave to follow.
Big Week. IP inbound. Ignore the flak, hit the target, see you at the bar.
Agree, Hemo! With all this potential, we should be way above $20 right now. In fact, I posted at the start of 2019 that we would be at $28 by Dec 2019. Alas...
So regardless of the filter's efficacy and range of possible applications, I think that a medical device (unless it's some da Vinci surgical robot) just lacks the "wow" factor of a new drug. If true, maybe that explains our lack of volume, possible investors just don't see the potential of something like this...until we really start to blow out some sales numbers and/or get FDA approval for something in the cardiac or sepsis arena.
Thanks for all your great posts, Hemo. Let's hope we see a healthy acceleration in SP after the next results call!
Thanks, Techxen! Yes, very strange there's no mention of the Chinese Jafron filter or Baxter's solution, I wonder why they only focused on ours.
Bottom line, it's more positive publicity. Pair this with a great quarterly results and we could/should see some nice appreciation, $20 by EOY is entirely reasonable.
Jerseyfish, if America had a few more million like you, we would be in MUCH better shape. I'll keep you in my prayers tonight for relief from your diabetes, and let's hope and pray for Leronlimab's success!
The next week or two could fall under the category of 'epic.'
Thanks for the history, LongTkt! Yes, you nailed it, the central mystery seems to be "how" our CEO "knew" PRO-140 would work. Another interesting question I would like him to address is why he got involved in the medical field to begin with, why did he "want" to be the CEO of nearly-BK Cytodyn? I just can't imagine changing professions like that, going from engineering to running a bio research company.
Bottom line, if Nader can pull this off, he'll deserve every accolade that comes his way, including a ticker tape parade. Then again, unless Black Ops has a few tons of ticker tape in his basement, he might have to settle for pixel parades.
Thanks again!
I'm with Onionhead on this: what did our CEO - an engineering PhD with no apparent med school or bio research experience - what did he see in Leronlimab that all the other Big Pharma experts missed? How is that even possible, that a bio/medical neophyte stumbles across a potential miracle drug?
If you have any more details, LongTkt, please share them, I think the NP/Leronlimab story has the bones to build a Best Picture kind of movie.
Thanks ut5678, Bulldog88, SmileyRiley, and Chuckles759, I consolidated your replies and forwarded them to my friend. Hoping she and her doctor follow through and Leronlimab gets another save!
Question for the Board: I know a 57 year old female that just restarted her chemotherapy for ovarian cancer. I see ovarian cancer is one of 22 solid cancers that PRO 140 might successfully treat. My question is, does anyone know the possibility of and/or procedure to contact Cytodyn to use their drug? Does the request have to come from her doctor?
Question for the Board:
If I understand how CYDY's current COVID trials are structured, the daily/weekly trial results are not even known by our CEO and our other doctors and board members. However, they do have access to the raw data on each patient, the results of each's blood work, data that might indicate if the patient received Leronlimab. Correct?
If so, then they should have a pretty good idea (roughly 80% chance, just to put a number on it) if Leronlimab is at least meeting the 50% success rate against COVID 19, a threshold established by the FDA. Correct?
And if so...then wouldn't this distribution agreement with American Regent be a REALLY GOOD indicator of success with Leronlimab in the COVID trials? I mean, if our CEO and our docs didn't see the kind of data they needed to see, why would they go through all this effort and expense to sign a distribution deal SPECIFICALLY FOR making Leronlimab available? This is NOT a deal to distribute Leronlimab for HIV/AIDS, it's specifically for COVID 19.
In short, isn't this announcement a REALLY SOLID indicator of Leronlimab success in the trials?
Good Stuff, Canes, thanks! I don't think I've ever seen a write-up where our filter doesn't help, and combined with its safety....there's just no reason for it not to become SOC throughout the world. Anxiously awaiting the sales results and other updates from our next call!
Great find, Two! I think the New York Times, The Paper of Record, has actually printed something that maybe, just might be true.
Champagne all around!
But pour me a Pabst.
MBX.TO was a recommendation from yielddude, a small biotech based in Canada. CTSO is my first love, but on the advice of basically everyone not currently protesting or looting, I'm considering other capitalistic options. Crazy, but when the Kingdom of Antifa sprouts up in the middle of Seattle, I feel compelled to follow the mob. Crowd.
Thanks for the tip, Yield, much appreciated!
Investing in 3 stocks - at the same time?? - does give me a bloated, post-Thanksgiving feel, but if it looks appetizing, I'll try some MBX.TO
Good Luck!
Thanks for the tip, Yield, much appreciated!
Investing in 3 stocks - at the same time?? - does give me a bloated, post-Thanksgiving feel, but if it looks appetizing, I'll try some MBX.TO
Good Luck!
Honestly, I don't know enough about any correlation or relationship between the personality of a CEO and the share price. I was in sales at AT&T for a while, and even though I hated every minute, I do know how important sales/marketing can be. However and obviously, there's a world of difference bwteen a Dow 30 company and a start-up biotech, so...in my limited experience, I think we first need a very steady, informed, and rock-solid individual in the wild-west biotech start up sector. Anything less could do irreperable harm to a company's rep.
But now that we have achieved a growing/reliable revenue stream without ANY bad news for quite a long time, I think we're well positioned for the kind of growth that we all have expected for a long, very long time.
Oh, and before I forget, thanks, coldterd, for your advice about 2 months ago on another small biotech. I still have my CTSO, but I have finally diversified into a SECOND stock. Yep, a veritible mutual fund of - 2 - stocks.
Go CTSO!
I met Dr Chan about 7 years ago, he spent 45 minutes with me 1 on 1 at a hotel investor conference just off Sunset Blvd/405 in L.A. He struck me as enthusiastic, straightforward, very knowledgeable, and down-to-earth. Easy to talk to and very receptive to questions. More cerebral than effusive, but that's not a strike, that's just who he is. Most of all, he struck me as someone who would not make over-the-top promises, and if you're an investor or represent investors, I think you would value that quality. With money on the line, you're retirement, you want truth, not hype.
In short, I came away very impressed with Dr Chan. Cerebral and grounded, but also very optimistic and excited about our product line!
Hang in there, Raptor, I've been here since MSBT as well. I think this year is different in many ways, we have many harpoons at the ready and there's no shortage of whales. Sacriligous 19th century metaphor, but I think Ahab also held some MSBT.
Question: Did you have (or do you still have) any connection to the F-22?
Thanks and Good Luck!
Thanks, Techxen, briliant post! (But I repeat myself.) Great research and analysis on this, I think CTSO's potential deserves either a buyout of at least $50/share or some kind of partnership that gets us to $30/share.
Thanks again and have a great week!
AMAZING POST, econ1! Many thanks to you and "Jiro," that was an excellent piece of research research/work. Better still, I love the result!
Go CYDY and CTSO, time to slay the cytokine storm!
I was born/raised in Milwaukee - yes, I'm bragging - and the fact that our filter is being used at Froedtert is great. Froedtert is a huge medical complex, maybe the biggest in the state, so we've got a great opportunity for excellent word of mouth to spread among the state's best docs.
Have a great Memorial Day weekend, time to remember and pray for our sons who never came home.
Thanks, Sting, good find! But how come on my 401k page (it's a very small page) - how come the "Analyst Opinions" by "Thomson Reuters Starmine" score our CTSO as "Very Bearish" and rank it a "1." Oh, and "Very Bearish" is also in red.
In short, our real world performance since 1 Jan ranks CTSO as the #6 investement on the Russell 2000...but Mo, Curly, and Larry rank us just above a carp.
Does anyone know how/why these analysts always seem to be so late to the game and so far off? Who would trust their money with these kinds of "Analysts," how do they stay in business?
GO CTSO, $20 by August!
Thanks, Raptor! If we're actually selling all we can make, I'm surprised we're not at $20 right now. I just hope the broader market doesn't suffer a second brader/deeper pullback in the second half of the year. However, even if it does, I believe we're in the right stock. No one wants to die before their time, and as our product becomes more known, our doctor/hospital awareness and market share will only grow.