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Find this drug in your link. They just filed for review on April 1, 2021. It’s not on your list either. In fact, none of the covid drugs under review are in that list you sent.
GlaxoSmithKline Inc Sotrovimab Immune sera and immunoglobulins, for human use 2021-04-01
We will have a PR tomorrow morning before market opens. Just watch!
Timing of LL approval - does it really matter (in your investment thesis) if LL is approved this month or in the second half of this year? The important thing is that the drug will save a number of lives when others have failed. Isn’t that more important than the exact timing?
Timing doesn’t work the way you expect with small biotechs, unfortunately. That’s the nature of the investment. You have to take a long term perspective. Big pharma have 1000 X more resources and experience, so they do hold the advantage here. However, they are risk averse and therefore are often very conservative with their R&D. As a consequence, major breakthroughs are typically made by small biotechs. This is where we have a tremendous advantage over big pharma. Take it for what it’s worth.
The harsh reality is that the market for COVID therapeutics will remain strong for decades. Consider anti-vaxxer, and other population that may not be eligible for vaccine for one reason or another. To give you some perspective, we still have around 50k deaths from flu every yr in the US.
Let's take whatever is being said (on either side) out of the equation. Don't you see the impact the drug is having on saving patient's lives? These are the most difficult to treat patients on deathbed that no drug has had success with. And this is backed by KOLs in US, peer reviewed publications as well as patient families. We have one right here on this board whose wife went through his ordeal (alongside him and his family!). That's strong enough reason for folks to believe in the power of this product. It's the solutions that matter and not so much who and how those messages are being delivered/perceived.
We will have a PR before market opens tomorrow, inline with recent CYDY PRs. Depending on the news, we could see a strong move towards $5 tomorrow.
The cost to borrow CYDY just surged. Interesting post.
https://www.reddit.com/r/CYDY/comments/mkso2k/the_cost_to_borrow_cydy_just_surged/?utm_source=share&utm_medium=mweb
How many of you think that Dr. Rahman is quietly executing the greatest turnaround in small biotech history? I guess time will tell, but the experience and confidence of been there done that for well over a decade with major regulatory agencies and big pharma is on display, IMO.
Very interesting. Big news expected Tues evening or Wed morning? Could it be FDA?
Appreciate your take, but I think they will grant EUA as well. It’s the right thing to do. Woodcock’s (and FDA’s) credibility is on the line. Just imagine every other (developed & developing) country saving lives via LL and US didn’t consider the drug. The media attention that LL is going to receive in the coming weeks/months will bring more awareness among general public. I expect there will be uprising in the US medical community as well. Folks will demand answers sooner than later. Just a matter of time.
They may be expecting positive news from UK, Canada, and perhaps Brazil too? And who knows FDA is giving them positive vibes as well? Either way, it augurs well and shows the confidence management has on upcoming order activity. Absolutely the right thing to do in terms of working with their partner to scale up manufacturing!
LOL. Very professional indeed. It’s funny that the attention of these folks has now shifted away from the science, mechanism of action & efficacy to financing & management practice, as suspected earlier. What will they turn to next? I am actually worried that some of these hedge funds are going to go broke with margin calls. You simply can’t keep the best COVID drug away for too long, especially during a pandemic when we are still losing thousands of lives every day in North America. We haven’t even scratched the surface with spreading awareness about LL and the impact it’s had on clinical outcomes. The movement is only going to get bigger every day.
Exactly. This is the standard operating template of AF and his buddies. I can point you to a number of such instances where they coordinated such action with other small biotechs. It’s a nothing burger, but it’s typically successful in spreading fear, uncertainty amongst new, uninformed investors. On the positive side, it creates a great buying opportunity for folks who believe in the science and keeps a mid-to-long term vision. In our case, this presented a tremendous opportunity to buy more a low 2s. Stay patient and good luck!
Well articulated, thanks!
Agreed. One of the chart analyst predicted a jump to $20 by early May. I think that’s a real possibility now.
Outstanding interview/discussion with Dr. Nicolas Randy. So powerful. I am going to post it on the CYDY page of Reddit. I encourage everyone to watch it! :)
Short squeeze coming everybody!
Unfortunately the pandemic is not going away, just like flu. We have on an average 50k death every year in the US alone due to flu. So LL is going to have a huge impact on these outcomes for years to come. I am not worried one bit about the timing. Just worried about the lives it could have saved in the interim. In it for the long haul!
I am buying first thing tomorrow morning as well. We certainly fill the gap and go back to at least $4 this coming week. Another piece of good news is we still have a ton of shorts, so that’s going to add fuel to the fire.
Lol, so now science and mechanism of action for LL is rock solid...but it’s only a question of setting the right dosage....thanks for at least acknowledging that...
Didn’t Elon Musk recently tweet Tesla is going to be the highest market cap company? The three best decisions NP made:
1) Buy LL molecule for a couple of million dollar (and turning that into billions of dollar market cap).
2) Get KOLs such as Bruce Patterson, Harish Seethamraju, et al. involved at the right time.
3) Hire Dr. Rahman, who comes with decades of experience with big pharma (Pfizer, J&J, etc) having an impressive resume of over a dozen successful BLA.
How many small biotech CEOs can claim that?
A simple way to look at it is CYDY is currently $2B market cap. HGEN is $1B market cap. So market is obviously a lot more optimistic about CYDY’s potential! Plus we continue the short squeeze this coming week and fill the gap. We touch a minimum of $4 this week. On any positive news, we go much higher!
Excellent & good luck with your legal issues! This is the golden age of investing in small biotechs and CYDY is at the forefront of that!
Weak hands are gone and the investors that remain truly believe in the science and see great long term potential for this miracle drug. Buying more first thing Monday morning and in it for the long haul! We could touch $4 or $5 next week. EUA coming this month with a ph 4 trial leading to full approval!
Savvy and well informed investors don’t question the integrity and experience of KOLs such as Dr. Bruce Patterson, Dr. Harish Seethamraju, Dr. Otto Yang, etc. In fact, they believe in the mechanism of action of LL and the impact it’s had on critical COVID patient outcomes. Why would these investors pay attention to any other messages when the authorities (KOLs), patient success stories, and peer reviewed scientific publications point in the direction of LL becoming SOC?
“But all that won't even matter now that a congressman is saying the FDA will approve Leronlimab. With an FDA approval CytoDyn's 1.3 million vile inventory will be sold in a few months.”
Great news! Buying more first thing Monday morning!
Does that mean Merck acquisition is a done deal and the DCVAX products will be over at Merck’s booth? Typically, you have an early bird discount to register for such scientific conferences too (been doing that for over 15 years). Surprising they haven’t registered yet.
Music to my ears!
I agree. I think NP, SK, & Dr. Rahman have said that FDA is supportive. The fact is FDA is working with hundreds of biotech companies and CYDY management has been fairly inexperienced in handling this. But Dr. Rahman is our man and he will bring his decades of experience working with FDA (via big pharma) and other regulatory agencies in guiding us through. I think a lot of strategic progress we have been seeing in the last few weeks is probably because of Dr. Rahman's thought process. He also lends credibility with ongoing FDA discussions.
Also, in my own personal experience working with FDA on the medical device front multiple times over the last decade, I know up close that they are not always the most knowledgeable on the science, mechanism of action, product, half life of a drug, and other such nitty gritty aspects. To some degree the manufacturer need to educate/inform them in a subtle way. Having said that, there is obviously a bit of bias with big v/s small companies in terms of credibility, but generally their intent is not malicious. In particular during this pandemic, I don't expect them to delay their decision for too long. Given how the medical community is rallying with KOLs writing letter of support, this makes our case even stronger and lends credibility to CYDY management and it's product. I do believe we will get EUA sooner or later followed by full approval.
The reality is this pandemic is not going away and COVID is here to stay for multiple years, unfortunately. There are also reports that the efficacy of vaccines may drop in less than a year. Plus we don't really understand the impact of the new variants that have emerged and any new that may come up. A number of countries in Europe, Asia, and South America are already struggling big time. At this point, CYDY provides the most viable solution to prevent folks from dying! My sense is that once we get EUA from one major regulatory agency, there will be a huge rush from hedge fund to get behind this company. And the projection of $20 by early-to-mid May that one of the chart experts (on youtube video yesterday) alluded to may not be out of question. Just need one domino to fall our way and it's not too far. Stay patient and good luck everyone!
Great call! Appreciate your contribution here.
That’s fantastic! An indication that they feel confident that DCVAX will be approved in UK and will become SOC in the coming months?
Is that more to do with quarter end or MM’s starting to get concerned that TLD could be any day now and therefore they could get caught on the wrong side of the trade going forward?
That's exactly the point. It's been 2 weeks and FDA hasn't denied it. They are reviewing in all earnestness and are in the process of providing conditional EUA. And setting the stage for CD-16 & CD-17 trial, which will be a home run! Ultimately that will lead to full approval.
I told everyone there will be one last attempt by shorts to cover before it gets real ugly for them. CYDY is doing reasonably well compared to how HGEN, RLFTF, and other COVID therapeutics are getting slammed today. Market knows it's far superior to any COVID drugs out there! We may get folks from HGEN and RLFTF to invest in CYDY real soon, if it's not happening already. That will lead to another leg up, in addition to short squeeze!
Intriguing connection with Merck.
https://mobile.twitter.com/scottyz177/status/1377082347774951426
Linda Powers has been a board of director at M2gen a few years back. And now Merck strikes partnership agreement with them. Certainly points to what we can expect with NWBO? She seems to be very well connected with inner circle of Merck executives/decision makers, connecting the dots!
Excellent work, thanks for bringing awareness about the potential of LL!
Dr. Peter A. McCullough mentioned Dr. Uriel Sandkovsky multiple times in that video circulated last night. Dr. Uriel Sandkovsky is the patient referral contact at Baylor for CD12 trial. Connecting the dots! Huge upside coming tomorrow as well.
These firms have been really desperate to find one meaningful client. No wonder they are having to PR every day to remind about the deadline, LOL. Someone said we’re going to close at 2.4 today and then head to bankruptcy....I’d say we get to over $3 tomorrow, and continue the short squeeze! Tens of millions of shares still short, officially....not sure how many more naked shorts we may have on top of that. It’s going to be fun!
LOL, those law firms are so desperate to get one client that they are having to PR every day that the deadline is coming up! ;)
Also, watch out for bankruptcy? It’s coming any day now! :P
That’s exactly what I was thinking!
Appreciate your and everyone’s effort on this board as well as folks on Reddit. There’s a ton of action there and the CYDY subscribers have been steadily growing. This is the new age of investing and folks like AF are in big trouble! ;) As I have said before, CYDY call will lead to his downfall more than ever despite his numerous bad calls and lies over the years. Coordinating short attacks with his buddies, planting BS stories during an ongoing pandemic, and throttling a company that truly improves patient survival outcomes when we are losing thousands of lives every day is going to haunt him the rest of his life! That day is approaching!
Agreed. The three best decisions that NP made are: 1) Purchase LL molecule, 2) Listened to Dr. Seethamraju & Dr. Patterson about the impact LL would have, and 3) Get Dr. Rahman on board.
Excellent. Dr Bruce Patterson should be nominated for Nobel prize! And CYDY, the drug of this decade!
Where are these statements coming from:
The DCVax-L vaccinehas passed Phase 3 clinical trials. It is admin-istered 6 times in the first year and 2 times inthe second year and can be combined withother drugs. The median overall survival aftersurgery was 23.1 months, while the medianoverall survival without vaccine after surgerywas 15-17 months.