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EXTREME WISDOM in your post, tradinplaces, I nominate you for both Sec of Interior and FDA chief!
On another note, I still remember the fragrance in the air around Clovis/Canon AFB, the heady mix of stockyards and July.
3 Questions on UK MHRA:
1. Does anyone have a best-case time estimate on when LL could be approved in the UK?
2. If approved for use in the UK, any guesses on how much of our LL inventory the Brits might want? And would NP perhaps throttle back their order size to also (potentially) supply the US?
3. Finally, does potential UK approval of LL mean anything for the European Union? Not sure where things are (medically speaking) with Brexit, but if EU agreements are still being honored, could we potentially see a rapid LL approval by the EU?
Fantastic post, Dr Rock! Many thanks for your info and time!
100% agree: given enough unstoppable force - a pandemic and a President - it is possible to move an immovable FDA. But movement on potentially life-saving treatments has to be the norm, not the exception. And if the FDA is like any other gov't bureaucracy, I'm sure they could easily flatten their process curve.
Thank you beartrap and Dr Bala, excellent info and quite exciting...most especially for those who can be helped!
Just as a last aside, I'm always amazed at how long it takes to get a new drug from lab to the public. I know small bio's are severely limited funding and staff, but if something shows promise, there should be an accelerated path to clear the admin hurtles/approvals in a far quicker way.
Has the FDA process ever been publicly audited? I wonder how much dead time could be cut.
3 Questions from a new NWBO investor:
1. When the top line data is released, what is the strongest evidence (right now) to suggest it will be positive?
2. Assuming the TLD is positive, what will be the next major catalyst?
3. Has management given any hints on their thoughts re: partnership and/or possible buyout?
Thanks and Good Luck!
Great points, Doctor Rock. I confess I was not for unblinding the data because I assumed we could get a more certain/statistically significant result if we increased our patient count. And the more impactful our stats, the better our share price (or so we hope).
However, though we're all here to make money, that is NOT the most important thing, not when lives are at stake. And if unblinding the trial means several months worth of patients could be saved, then that trumps financial considerations.
In short, you're right. If unblinding the date means more will be saved, that must be our course.
Thanks for your posts and God Bless your work!
Agreed, Latane, NWBO is tracking just like CYDY except with about a 3 month lag. I just bought into NWBO yesterday...so today's tanking is on me, I always, ALWAYS, seem to buy just before a fall.
I assume you're in NWBO as well? CYDY is far and away my biggest holding, I got into NWBO and NEXCF for a little diversity. Because, of course, diversity is our strength. Though if NWBO and CYDY get any stronger, my portfolio will look more like a crash site.
Long on NWBO and CYDY, stay off the auto-land/auto-throttle and good luck!
Media Questions:
1. Was today's FOX interview pre-announced?
2. If not, why not? Why wouldn't NP issue a press release yesterday or this morning announcing the exposure, which, for Cytodyn is huge?
Seems odd why he wouldn't PR this in advance to maximize impact and value, unless, of course, it all happened so fast, i.e., Neil Cavuto calls up at 0800 and says "hey, let's chat."
NP did allude to more big media interviews, I believe, so lets hope he continues to impress!!
My neck on the stump is right there with you, Latane,
no shortage of CYDY turkeys.
Question: Do we actually know what NP does or doesn't know about the results soon-to-be-released? Seems it would be career-ending stupid to appear on national TV with all sorts of enthusiasm...and then disappoint with lousy results just a few days later.
Do you think NP knows?
Strange, isn't it. I've never met misiu143, nor do I know Rockleo or BlackOps or Salz or Latane or anyone else on this board. But when I see some poster attack their integrity or impugn their motives, it gets my hackles up. Dr Mengele and a few others excepted, insulting a doctor just isn't right. I welcome differing opinions, but I devalue those that swerve into ad hominem attacks.
I have great respect for misi and Rock and the other medical people on this board and attach outsize weight to your opinions. Please keep them coming, I read all your posts!
Nice post, HH! Just keep Lt Pourhassan off PT boats and away from Japanese destroyers, we should be fine.
Damn the torpedoes and the shorts as well,
full speed ahead!
THANKS, Learning53, Excellent and exciting post!
Sincerely sorry you lost your MD friends, Dr Rock, I had no idea doctors were so much at risk.
Best guess, do you think your friends who contracted COVID got it through aerosol transmission - or on an infected surface? I know doctors are surrounded by germs, but with all the precautions you guys take, all the hand washings and your discipline with effective masks, I'm surprised so many were infected.
Again, my sincere condolences, Dr Rock. May God bless your health and work!
Realistic expectations for today and tomorrow?
At the least, should we expect a summary PR of the UK and FDA meetings?
At best, could we possible get an approval or two to sell?
And what's the intermediate case, the FDA/UK want to schedule another meeting?
"Always with the negative waves, Moriarty!"
Hello, Hemo, I'm always impressed with your reasoned responses and depth of knowledge on all things CTSO.
Can I ask what your background is? Are in the medical field, do you work in the pharma world as a researcher or in upper mgmt?
Thanks for all your input, and I hope you (and the rest of CTSO's longs) can enjoy the day!
Questions on This Week's Expectations:
- Could the UK give us a "buy"/"no buy" decision this week, i.e., an actual product order?
- Could the the FDA give us a blanket Covid approval or EUA this week?
- Could we get a NASDAQ application approval or rejection this week? And would NASDAQ first wait to see if we get a UK or FDA approval before they make a decision?
- Any other approvals or significant news (e.g., publication of LL article in a medical journal) possible by Friday?
Shaping up to be quite a week, this reminds me of watching Apollo rocket launches as a kid, the crowd cheering the rocket's climb while shouting GO GO GO GO GO!
Excellent info, thank you Dr Misiu! I will craft my email and include your words. Have a great weekend and thanks for all your posts and expertise!
Thanks, Dr Rock! I will "remind her" of LL's potential again today. Better to be a pain in the butt than the alternative.
Have a great weekend, Dr, thanks again for your input and answers! I think we're sailing into the biggest week in CYDY's history.
Hello, Dr Rock and other Docs, question for you: I know a woman who has been on chemo for ovarian cancer for the last 2-3 years, and in the last 2 weeks, she found out the cancer had spread to one of her breasts. I had told her about CYDY/LL back in June and urged her to fwd the links/info to her doctor, but I'm not sure if she did. Regardless - if the cancer has spread, do you think it is to late to try LL? Would success now be much more difficult?
I know I'm not giving you anything in the way of real specifics, but if you think Leronlimab still has a decent shot, I'll follow up with her again.
Thanks for your time!
Oh, Nurse? Nurse? Question: What do you think the chances are that Zoom (or some other potential competitor) are 1. doing what they can (via shorting/manipulating) to suppress our SP so they can 2. potentially buy NEXCF and use their tech.
Do you think we're ripe for a buyout in the next few months?
And do you know if we have any "poison pill" protection from a low-ball purchase price?
Question, Mr Grip: Re: that 500k share trade, how come - when I look at the little SP and volume charts here on ihub - how come the price remains relatively flat for approx 30 minutes after the trade (just before the 13:30 mark)? Shouldn't a big walloping blue spike wipe out most of the asks at that price level and immediately drive our SP curve north?
Best line: "With TAG putting on 150 events annually, the opportunity for expansion is sizable."
Thanks, Nurse, I see blue skies ahead!!
Hah! Looks like June 30th again on my Fidelity real time chart, is this what UP looks like?
Latane,
"...but they work to protect Big Pharma from any threat. Add them to the dung heap of all the other corrupted institutions and people now controlling this country."
Agree 100%, great post!
For Smiley and the rest of you IHUB Kings, what's the informed consensus re: tomorrow's call?
Scenario 1: Approval news?
Scenario 2: Some nation has placed a large order on results to-date?
Scenario 3: Some non-Covid, very positive update?
Scenario 4: Nothing specific, just a progress report on various efforts?
Hoping for Scenario 1 or 2, I miss the double-digit SP of June 30th.
You’re a stand-up guy, Fantom, thanks for your kindness to the children and for all your work!
Thanks, Latane and Saltz, your replies/insights very much respected and appreciated. The next 8 weeks should be quite a ride. And regardless of the obstacles, with continued good results, we WILL succeed.
Failure, and staying on the OTC, is not an option!
Welcome, Jules, and your suggestion to "sleep with the enemy" is, at the least, interesting. Distasteful, certainly, every CYDY investor would first have to be inoculated, but - ?
Who knows, maybe a joint effort is the price of admission to the Big Leagues. I have no pharma or corporate C-level experience, but big picture...if the right deal can be cut, we might even "owe it" to the sick and the dying to at least consider such a thing.
Would be interesting to hear what Salz and Black Ops and the others think about CYDY + Gilead, at least for COVID 19.
Right there with you, Latane, sounds like we’re both “all in” with CYDY. No dry powder left, all sound financial advice and planning has been jettisoned. Escape velocity or the cold Atlantic, the burners are lit!
Thanks, Sting! And I agree, these are not stupid people, at least not as stupid as me.
The MSBT-CTSO train continues to gather steam, and I agree with other posters here; our company and opportunities have never looked better or been closer to paying off, hang on and hang in!
Great reply, Smiley, but to specifically answer AF's question - "Can you cite the data specifically which leads you to believe that leronlimab works against COVID 19?" - could we not reply with the NEWS2 results? Isn't that a quantitative (clinically and statistically significant) result?
And shouldn't AF be aware of our NEWS2 score?
Here you go, Trend, this is from "Frank" on the Yahoo CYDY message board:
"To use Nadars words: not AF, not WSJ and not SA or any other lies will decide on the final outcome regarding approval. And also not the stockprice at that very moment. All what counts eventually will be the results of the clinical studies. And All what I have seen so far, from the mode of Action, the IND patients, the M&M Trial, the input from world class scientists including Patterson makes me very confident that the outcome will be EUA from mild to moderate to severe and also critical. I have zero doubt about this. Some of you know, others may have missed it so far, I worked for 4 years for the European Medicine Agency, another 4 years for a national European drug agency and 15 years now in another European regulatory scientific Agency.
Today I have sold another part of my gold ETF and I am going to buy more of that company. I suspect that will be a W correction which will be a very solid basis for the near and midterm future.
Like you I am annoyed by these unprofessional, misleading or even intendently misleading „journalism“, some of them blunt liars (AF). But don‘t be too annoyed about the shorts. Every shorted stock has to be covered eventually and then this will (over)compensate what you may perceive today as a „loss“.
It is not a loss, you still own the same proportion of this company.
I can understand that those with less scientific background get easier doubt than people with scientific background. I have read a lot here about leronlimab, it’s mode of action and when I worked for the Eiropean Medicine Agency I was responsible for vaccines, interleukin (I assessed with colleagues and experts the one from Amgen), and monoclonal antibodies. In addition I did. my PhD in Virology and meolecular biology. Although some of the above is already 15-25 years ago, I still understand that stuff.
In my last 15 years I was working at a higher position in risk assessment and public health and when I see I have assessed more than a 1000 clinical studies (from full pharmaceutical study reports of 300-800 pages to shorter scientific articles in peer reviewed journals.
I tell you: leronlimab will be approved. You may have seen all my considerations about the need of a phase IIi study or direct EUA.
At the end I just don‘t know when, because FDA, EMA, UK MHRA have all some margin here: they can approve, but they may also ask for a confirmatory P3 study. BOTH could be reasonably argued for M&M. Whatever outcome, I will NOT blame these drug bodies, because I know you could argue more as a scientist (then you would ask for phase III study), but the decision could also be more a risk management decision (EUA is that per se) and argue: no concern on safety plus NEWS2 data, IND results and MoA supportive evidence - approval.
Regarding S/C III - THIS will result to EUA, but again, I do not know whether p-value below 0.05 is already achieved with 195 patients (we just have them since 2 days or so) or whether we need the full 390 patients. That depends largely on the mortality rate in this study population (statistically: the more the better!) and from the effect size of leronlimab on mortality.
I am annoyed by WSJ misleading and false articles, low creature AF would do anything for money.... but who cares: We have leronlimab, this drug works and we all, owing this company will show that to the whole world. And when this happens this year (maybe tomorrow, maybe October, maybe later) we all will be very proud. Proud for our investment decisions and proud for what we have supported with our investment: saving lives of fathers, mothers, grandparents, friends, maybe even our own. Keep faith, by my daughter, this science is real and true."
FYI, Great piece just posted by "Frank" on the Yahoo CYDY message board, very informative from a scientist with a European medical agency background.
Hold on, Leronlimab's future is BRIGHT!
You make a great point, moneycrew! I don't have a long history with CYDY, but isn't it unusual to release a PR at this time of night?
Maybe the PR people (person) are just so busy that they issued the news without any strategy/plan re: max benefit to the company.
Or maybe there is something else coming tomorrow AM.
Or maybe this is just to throw off some of the shorting pressure, i.e., set a pattern of releasing positive PR's at any time?
Regardless, the next 8 weeks should not lack for shock and awe, let's (re)light this candle!
"In his new role with NexTech, Winschel will be responsible for scaling the company from a 70 person organization into a global powerhouse of 700 people or more, for next-generation augmented reality and video conferencing solutions."
Thanks for the article, nurse, sounds like we're on the right track!
Thanks, Nursetrader! And I hope your patient care leaves enough time for your trades, got to set your priorities. :)
Good Morning, Nursetrader! 2 Questions:
1. How did you find NEXCF, how did you hear about it?
2. What's your expectation on SP by the end of the year?
3. Are you also in Shopify?
Thanks! I bought into NEXCF a couple of months ago because I saw a video of their AR and was very impressed. I also bought into SHOP about 2 years ago at $104....then got out. Smart move, eh?
Rock and BlackOps and Saltz and All Other Great Minds -
3 Questions:
1. Do you think Pres Trump has been briefed on Leronlimab's positive NEWS2 clinical results?
2. Do you really, actually, had-to-bet-all-your-CYDY-stock think that the President's FDA/medical advisors/appointees would downplay or minimize Leronlimab's success because we are not in the big pharma "club?"
3. Best guess, why didn't the FDA greenlight LL for immediate/emergency use within 72 hours after seeing the NEWS2 results? Did those results (combined with the safety) not prove (with > 95% certainty) that LL is currently the best COVID 19 bullet in the world?