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Do we have data on the efficacy of Pfizer, Moderna, and other vaccines after 6-9 months of second dose? I hear that it drops significantly after 6 months. I guess it's a bit too early, but just curious if there are any research studies with folks that participated in clinical trials and how they are doing now or few months down the road.
Philippines doctors confirmed that EUA was filed in their internal presentation as well. They have been in touch with CYDY team and believe LL will be granted EUA by the US. Trust Dr. Rahman to deliver!
Yeah, we got this! Lots of action on Reddit too. By the way, Dr. randy Nicolas is quite objective and very well researched. I have listened to their previous talks on YouTube as well.
This is fantastic. I am going to post it on Reddit too. Dr. Randy Nicolas confirms that EUA applied over 10 days ago and is very positive on the results!! Very nice presentation!
We move back to $5 on EUA news next month?
Agreed. Trust in the science, KOLs, and take a medium to long term perspective. Small biotechs are not for faint heart. We will succeed. I am actually happy that we still have shorts as we will see a bigger pop when do have big news! This is a golden age of investing in small biotechs.
Thanks! I’d say we have EUA in 2-3 weeks. Janet Woodcock is getting hammered on Twitter. There is just an outpouring of support for LL.
Out of curiosity, what’s your ETA on bankruptcy filing?
What’s the likelihood that FDA grants EUA in the next 2-3 weeks and we may not even be required to do CD-16 & CD-17 trial?
Excellent, thanks!
Great info!
You didn’t respond to my previous post. It seems you don’t believe in what the KOLs such as Drs. Patterson, Seethamraju, Yang, et al. have to say about LL, it’s mechanism of action, and the impact it has had on saving patient’s lives. We are in a pandemic and if I were FDA I would want to have all the tools in my arsenal (with excellent safety profile!) to protect the people of this country. As I have said, Dr. Rahman’s experience will guide us through this journey going forward.
Agreed. They have Dr Rahman now, who is quite accomplished and experienced with successful BLAs (over a dozen of them). We are finally going to have a fantastic year. Just need to stay patient and give Dr. Rahman some time to shine.
Novavax’s story much like CYDY. They have the most effective vaccine but don’t have approval yet. It’s valued at $16B market cap. Similar valuation would put us at $25-30 per share price. Just saying! ;)
https://www.reddit.com/r/CYDY/comments/mbtzma/novavaxs_story_much_like_cytodyns/
Not sure I support the theory, particularly going short on such small biotechs that have profound impact on saving people’s lives during this pandemic. And in the process throttling them of funding (& innovation) and increasing time to get to the market. I guess there are many other ways to make money!
Excellent work. I will call later today!
Another thing that jumped at me from yesterday's call was NP's response to buyout/partnership. Opens the door for big pharma to come in and put an aggressive offer. Dr. Rahman worked in an executive position at J&J, Pfizer and Novartis, so needless to say he must still have strong network with the leadership teams at those companies. And for these big pharmas there would be comfort in knowing that Dr. Rahman believes in the product and technology. Of course, they know it too! Pfizer and/or J&J would make a lot of sense.
Here’s another great article that just came out:
https://insiderfinancial.com/cytodyns-smoking-gun-for-an-immediate-eua/181182/
Let’s continue to forward this to all influential politicians, media outlets, social media posts, etc. Lets do our bit and continue to spread awareness. FDA sees the potential in LL and that’s why they haven’t discontinued eIND, reimbursement codes (they still exist with the expectation that it will be approved) and are asking them to collect more data. However, there must be a bit more urgency around this when we’re in a pandemic losing hundreds of lives everyday.
Read all the way through. CYDY mentioned in this report.
https://insiderfinancial.com/reddit-rebellion-targeting-the-short-mafia-next/180939/
Agreed, that was also for me the biggest take away. I just listened to the CC and it's super evident that Dr. Rahman's clear thought process & experience is rubbing off in a positive way to the rest of the team. Either way, Dr. Rahman will make the right calls & guide us through. We are certainly in safe hands! Probably the best decision NP made other than acquiring the molecule!!!
Great clarity on HIV BLA! Again, Dr. Rahman will get us to the finish line this year. He seemed super confident on what's required, how to address it, and what sort of back and forth to expect. That experience of being there done that with big pharma can not be understated.
"I have no doubt that CYDY is going to hurt their credibility the most"
-- lol I actually didn't think they had any in the first place. Ever read some of their 'hit' pieces? Grade school 8 comes to mind (no offensive here).
---> LOL. Agreed. For some of us that have been doing this for a while, it's crystal clear. In fact, it's a trigger to invest more! :P
"I have often said that the advent of information technology platforms have created level playing fields for retails. "
-- 100% agree with you. There are some folks on multiple board that would put the best analysts (I remember wainright used to follow this stock) to shame. Beauty of high speed data at ones finger tips.
---> Well said.
Thanks. Despite all of their (AF) unsubstantiated rants and missed calls on other small biotech companies in the past, I have no doubt that CYDY is going to hurt their credibility the most. We are in a pandemic, losing hundreds of lives every day. Families are struggling and this is just the beginning of social activism. Some of the folks could get in serious trouble in the coming months. It wouldn't surprise me if this will result in a review of FDA activities too. Not going to happen overnight but an year or so down the road, we may look at this as a big moment. This movement will not die down!
I have often said that the advent of information technology platforms have created level playing fields for retails. Everyone can do their DD, review publications, listen to scientific talks, and make their own judgement rather than listening to folks without a science degree. The sleazy tactics of these shorts are not going to work anymore! Their only goal is to create fear and uncertainty and I must admit they succeeded to some degree. But the weak hands are now gone.
I am not arguing that CYDY management must take some responsibility for their foresight and decision making in CD12 trial. Shows lack of experience. Dr. Rahman is going to spearhead their regulatory affairs and trial design going forward. He didn't join the team until late last year. He has successfully lead over a dozen BLA with big pharma. So that issue will be taken care of!
But the larger point I am trying to make is that the science and technology is better than anything that's been tested and reported for severe to critical patients. Show me one study that presents better data than LL for critical patients? I point you to few below. With all the exceptions that FDA made for big pharmas in approving their drug and Fauci @ NIH pumping ph 1 trial of big pharma, isn't that hypocrisy?
Harish Seethamraju, M.D., Medical Director for the Mount Sinai Lung Transplantation Program, commented, “The CD12 trial results are very promising and leronlimab may be the only safe medication to help critically ill patients.”
Is he pumping the stock? I don't think so.
Dr. Patterson wrote a letter in support of CYDY last week to FDA. Why would he do that despite the differences that may have emerged with CYDY management in the last few months?
You out of all know the struggle of small biotechs. I assume you're long NWBO as I am. 13-15 yr long GBM trial? What happened there with AF and his buddies putting all kinds of non sensical legal stuff as hurdles about 6-7 years ago and the resource NWBO had to put to fight the legal cases questioning integrity, trial design, etc. In fact, he's been on recording for the past 7-8 years saying NWBO trial failed. Seems he knows more about the data than anyone else while it's not been unblinded for everyone else. And calling Linda Powers the worst CEO ever. We know NWBO emerged victorious from all those baseless allegations and is on the verge of revealing their Ph 3 data to the world. It's up 10x in the last 12 months! Ultimately science and KOL support wins! NWBO hasn't revealed the ph 3 data yet and we don't know if FDA will approve it either. But it's clear UK MHRA and EU will given the acceptance of end point changes last year and the scale up of manufacturing in the UK over the last 6 months or so!
Here are some of the publications with LL for reference:
https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1583/5932277?login=true
https://www.sciencedirect.com/science/article/pii/S1201971220323055
https://www.sciencedirect.com/science/article/pii/S2589909021000034
https://www.medrxiv.org/content/10.1101/2020.05.02.20084673v1
And someone was complaining that no one is at their office in Vancouver, WA? Or were they calling impending bankruptcy? LOL!
With all due respect, I disagree. Tell that (LL doesn't work) to Marksch1 on this board whose wife recovered or that lady in NY whose grandfather recovered when nothing else worked. There are so many of these real world patient stories, supported by Dr. Patterson, Dr. Seethamraju, Dr. Yang, Dr. Agresti, etc. in talks and peer reviewed publications. Do you think these guys would stick their neck out to support LL's benefits and mechanism of action? I wouldn't put my career on the line, particularly for a small biotech!
Agreed. It's a classic credibility and big v/s small biotech issue. But I think we all must do our bit and spread awareness about the solutions. Peer reviewed published data backed by Dr. Patterson, Dr. Seethamraju, Dr. Yang, et al. with real world patient experience tells a different story. That's the least we can do.
Also, it's timely that we bring to light the issues, be it that doctor and executives at the NY Presbyterian hospital, and/or the corrupt authorities at FDA. I have personally worked with FDA authorities on medical device approvals and I know how these things go. I won’t go into those details but we should all start a movement in various social media forums to bring awareness and demand answers. And that lady and her family in NY with real life experience (traumatic journey!) can be that voice on all these platforms! Let’s go and do our bit by rallying as many folks as we can on every social media and big media houses!
How about also tagging Alexandria Ocasio-Cortez, Dem Rep in NY regarding that family's journey at NY Presbyterian hospital? Alexandria is quite active on social media and an activist! Perhaps she can help!
You are truly persistent and a hero! I wish you and your wife well. We are not living in an underdeveloped (3rd world) country and its unfortunate that you (and your wife’s doctors) had to go through this for what we all believe to be the greatest country on this planet.
You feel! ;) it’s obviously coordinated by his gang. If a thorough investigation is run, the racket is exposed! Either way, I do expect a GME like scenario in the coming weeks as more awareness spreads. A lot of folks are going to get in trouble. Reddit and social media is going to explode.
Yes, I did. I put a message out on Reddit as well, which resulted in a lot of traffic (awareness).
Sad story of our healthcare system. This lady says her grandfather was saved by LL. Her partner’s grandmother is now pretty much on a deathbed and the doctors says they don’t want to apply for EIND because it’s too much paperwork. Unbelievable! Perhaps put her in touch with Dr. Seethamraju?
https://www.change.org/p/new-york-presbyterian-hospital-save-grandma-from-covid
By the way, these guys started shorting when the stock was at $1. Even sooner I think. And that lawsuit was after things started moving in the wrong direction for them. It didn’t work then and won’t work now. It’s surprising they are still hurting! More so than any of their other bad calls, this one is going to hurt their credibility the most and potentially lead to their downfall. The social activism and awareness around CYDY is going to continue to grow, when we are losing hundreds of folks in the US everyday.
Have you ever seen so many law firms involved? Tells me shorts and big players are so scared of Cytodyn that they are resorting to whatever tactics they can find to slow them down. By the way, it’s their standard operating template. Have seen this in a few biotech stocks I have been involved in over the years. Unfortunately same folks involved, same tactics, but the end result eventually was all positive. Lawsuits do get dismissed (some sooner, some take a while, but in this case, it will be dismissed very quickly as this scream desperation from nefarious characters), and companies with game changing science wins out in the end.
Trust in what Dr. Patterson, Dr. Seethamraju, Dr. Yang, Dr. Agresthi, Dr, Been, and others have to say. Why would you want to listen to anyone with no hands-on experience with the drug and who are not physicians/researchers? The weak hands are gone, so I am not sure if these tricks are going to work anymore. On the other hand, this renewed attack/desperation from shorts is good news for longs. They know their end game is near! Great buying opportunity, imo!
Hang on, we are going to get huge short squeeze any day!
Agreed. Well articulated. Buyout is indeed coming. Just a matter of time.
LL said this in an interview last year. Her words:
The ideal company would be ...almost like an Uber or Amazon...something that turns an existing industry upside down...not only the ...FDA approval process...but also how to scale that up once something is approved or adopted.
No wonder she got Merck (Keytruda) involved in a combo trial with Northwest Bio (DCVAX-L) not too long ago. Everything points in one direction! ;)
Remember that the payment cycle for the latest financing starts Nov this year. So they must be expecting approvals and revenue to start kicking in well before that (and/or buyout!). ;)
Is LP setting up UK manufacturing to justify buyout with Merck? US is set with Cognate/CRL. If Merck were to justify an acquisition over $20B to their stakeholders this year, their leadership team will get questioned how fast they can scale up manufacturing, what sort of revenue can be brought in 2022, and how they can grow top line revenue on a yearly basis. They must have made 5-10 year revenue projections. And for all the future potential with other indications, the executive management will certainly need to justify near to mid term revenue projections as well. Otherwise, I am a little skeptical they would invest over $20B in such a buyout this year. Thoughts?
Unbelievable, someone with influence in NY area should try to help this lady save her grandmother. This deserves serious media attention too! Please someone with the network and influence reach out.
https://mobile.twitter.com/Sk8tergirl1989
It’s becoming increasingly clear that the data is going to be outstanding. Just not clear which of the high impact journal the data will be published in! Investments in the UK and the confidence by the local authorities is a testament that approvals in UK and EU are guaranteed. LP is simply toying with shorts and not giving them what they need by issuing TLD without a strong peer reviewed publication to back it up. They know very well the misinformation campaign shorts will run even on strong data until regulatory approvals. She has learnt the hard way given the history. Not this time!
We are unfortunately going to have another deadly wave with the opening up of various businesses and with folks being more complacent and acting like we are back to normal. There is a consistent uptick in cases over the last week or two in many countries.
https://www.cnn.com/2021/03/20/health/variant-b117-vaccines-work/index.html
Agreed. We are way undervalued. Look at NVAX. Their vaccine is not yet approved and they are at over $16B market cap. Plus they have a lot more competition in the vaccine space already than we do. In fact, we do not have any competition in critical covid patients. Moderna is close to $60B market cap. With one EUA (for critical covid), we ought to be minimum double digit share price right away. And once we have results from NASH, LH, update on HIV BLA, and other trials in the second half of this year, we will be in $20-30 range, IMO.
It’s March 19 and the new short rule is on. Hence these MM’s are less likely to short & manipulate prices on daily basis. They also know their tricks are not going to work anymore with weak hands gone. Plus you don’t want to be short over the weekend with good news around the corner!