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I have been working in the medical device industry in various leadership roles (my previous job being with one of the top 5 medical device company) for about 20 yrs as well. And I do have experience working with FDA as well as other regulatory bodies across Europe and Asia. KOL clinicians have an excellent inter disciplinary team around them that provides them the insight they need. Also, they are uniquely positioned to see direct impact of the technology (whether it’s drug or medical device) on their patients in terms of outcome and care. So I do not agree with your statement.
Agreed. Shorts are trying to create panic as much as they can over the next few days so they can cover, but in reality these news pieces could come any day. If NP is able to trap shorts, then we may get much higher than 100% gain when the news hits.
https://www.cnn.com/2021/03/13/europe/italy-coronavirus-national-lockdown-intl/index.html
Starting to happen in many other countries, unfortunately. I think LL will be able to serve this market and address the unmet needs of critical COVID patients for a decade or longer.
I agree about the investigation. Their standard operating template. All connected!
Anyway, I am curious about the involvement of politicians and the potential of 180 flip from FDA? If true, this is massive! We run to double digit in no time! I am a firm believer that real science can not be stopped (during this pandemic) in this day and age of information technology where the publications and real data are readily available for anyone to make evidence based conclusion.
Believe in the science and KOLs! Dr. Rahman is now in charge of trial design, execution and communication with the regulatory bodies, having lead over a dozen successful BLA with big pharmas as an executive. We are in good hands! Hang on to your seat belts and enjoy the ride!
Ongoing FUD from Paul Santos, AF, et al. strengthens everyone’s belief that CYDY will knock it out of the park with the 140 critical patients trials. This is their standard operating template to flip flop and continue to create panic for novice investors and weak hands. They are all gone now, but it’s reassuring that we still have naysayers (aka shorts). Will certainly provide fuel to the fire as soon as we have a meaningful update! It could be the start of 140 patient trial, new major investor from LA, conditional EUA from US or other countries, order from Philippines, etc.
"Note though, Scott Kelly mentioned an LA billionare that they were meeting. Mind you, Scott said this, not NP"
When was this mentioned? Are you able to share more details about this conversation? Very exciting indeed, if true! :)
FDA knows LL works! Otherwise they would have shut down EIND last week for severe to critical COVID patients, and not approved ph2 for LH studies. Perhaps no one at the FDA wants to stick their neck out for a small biotech firm (and perhaps set a precedence), but deep within they know very well that the drug works as intended. Therefore, they are asking CYDY to run a quick 140 patient trial with critical patients, which everyone knows will be a home run! Would they have taken a similar approach with big pharma (say a Gilead, Pfizer, J&J)? No, and that's what is painful - their double standards. It's unfortunate, but credibility and money influences a lot of decision making than real data points!
Silver lining for us, once we hit EUA on COVID critical patients in 3 months, sky is the limit! Until then we get back to around $5?
I have been predicting March 17/18 coinciding with my dad’s birthday, lol! The last run up over $2 was around my sister’s birthday. Fingers crossed!
That would make sense given how they have always said they will go after UK first as MHRA has recently shown they are quicker than FDA. Plus I am not sure if this impending approval is the reason they pushed Joel’s therapy to April. They cited COVID resurgence as the reason for pushing it back but it could very likely be that they’re anticipating approval before that time frame....and Joel could be the poster child & first one to get DCVAX-L post approval?
By the way, given his strong network & relationships, I wouldn’t be surprised if one of these outfits make an aggressive buyout offer in the second half of this year once we have the EUA/approval for COVID critical patients. They will need to bring their checkbook given the huge potential, but then big pharmas are flooded with cash and interest rates are still so low!
Dr. Rahman is going to lead our efforts going forward, so we are now in safe hands. He has been there, done that with Pfizer, J&J, Novartis, etc at an executive leadership position with over a dozen successful BLAs.
From Pacific NW as well. In Oregon.
Very well put and I agree! I have been accumulating as well.
Why not Seeking Alpha, StatNews too? Well, I guess if you do Citadel and/or Citron, the others will be exposed as well as they are all connected! ;)
Interesting take from Dr. Been on his lecture yesterday about LL and the influence big pharma exerts on FDA. Go to min 23 on that YouTube video (link below).
By the way, Reddit has been exploding. It’s only a matter of time. Trust your research and Key Opinion Leaders!
Exactly. These guys have been short since $1.5 from what I read in one of the reports from an year ago, and they are likely still in red with all the margin calls and interest they must have paid over that period. Overall, the last couple of yrs have been brutal on these short sellers across the board.
I’d also include Dr. Rahman. He seems to be the best of the lot with an impressive track record and good clarity. I trust him to get us to the finish line!
Agreed. Andrew left from Citron was banned from trading in Hong Kong stock exchange for 5 yrs. I provided an example earlier today where they (Citron) put a bogus report out on Blink charging in August 2020. Stock went from 12 to 6.5 in a couple of days. Look at where it is trading today. Up 5x (over 32). Don’t know if anyone can find an image that was circulating (on Twitter) in January showing the faces/profile pics of AF, Andrew Left, Tim Sykes, Gabe @ Melvin capital, couple of Seeking Alpha writers, etc. all connected and a cross against the face of Gabe @ Melvin after the GME debacle. It was quite hilarious and shows the close connections of these guys! Someone should try and find that!
Excellent. They know that good news can come at any moment, so better play their tricks and cover as soon as possible! I am in this for the long haul.
Yeah, just bought more. Trust the science and KOLs!
A good example of what they do:
https://finance.yahoo.com/amphtml/news/blink-charging-responds-short-report-191846518.html
Blink charging was slammed from around $12 to $6.5 back in August 2020 based on these false reports. I was fortunate to buy during the dip at around $7-8 level. Look at where it is trading now (over $32) in about 6 months. There are a ton of such examples. Basically, they play on novice, anxious, and uninformed share holders unfortunately. Do your own homework. Nothing can stop CYDY from generating multiple billion in revenue this year. Conservatively speaking, multiple by 5x just on COVID success. That’s minimum $10B market cap and therefore double digit share price. HIV, NASH, basket trial upside is not even factored in!
Agreed. When you are on a game changing journey, most of them will think you’re nuts! Did anyone really know about Elon Musk 20 yrs ago during his PayPal days? Even when he started Tesla, everyone thought he was nuts and made fun of his vision and said he would not succeed. Well folks still don’t get the real play on Tesla!
Anyway, I thought the CC was reassuring. In particular, Dr. Rahman was very honest and upfront in his comments, I thought. He has good clarity and his track record of success & experience with big pharma (over a dozen BLA drugs approved) will certainly get us through this time. He is in charge of the design and execution of this 140 patient trial. Needless to say, I trust him to deliver! Plus science is undeniable!
Agreed. Real science and truth will ultimately prevail regardless of the divisions and doubts shorts may want to create. It’s a great opportunity for Dr Rahman to be involved early on during this process and draw upon his experience to ensure they are on the right track this time around with the design and execution.
Yeah, bought more under $3 today.
Well, they did produce statistically significant results in terms of reducing the number of hospitalization days by 6 days (patients emerging alive). Also, their mortality data with critically ill patients was really good (24% reduction on small sample size though - 62). No one has showed such numbers. Head of FDA has repeatedly said that she won’t care about p value (or statistically significant value) as long as it’s clinically significant with saving lives of these covid patients. And now because it’s a small biotech and not one of the big pharmas such as Gilead, Pfizer, J&J, etc. they wouldn’t grant EUA and rather ask them to run another 140 critical patients before granting EUA. This way, big pharmas catch up? In the interim, let the critical covid patients die every day? We still have over 700 people dying every day in the US. There’s no drug that has demonstrated such results with critical patients so far. Safety profile is excellent. The same drug has been studied and have succeeded in HIV ph 3 trial. In totally, they have safety data from over 2000 patients in all the ph 2/3 trials CYDY have run. What’s missing other than they don’t have the credibility and deep pockets of big pharmas?
Agreed. There have been accumulation. I put buy orders at 1.29 on Friday and noticed that it didn’t fill any of my orders when the price hit that number momentarily couple of times after I put my order.
My intuition says TLD Wed, March 17, and publication on Thu, March 18!
I do believe strategy of waiting for a top notch publication is the right move. This way, there will be no doubt/distraction, and will give us the maximum pop around TLD. Look at the misinformation campaign AF and his crooks have been running against CYDY over the weekend as soon as their Ph 3 results were announced. They have produced the best results on critically ill covid patients so far of any drugs. They have been bashing and don’t care they have blood on their hand when hundreds of patients are dying everyday!
I am assuming you covered already? Or you’re so confident it will go to $0.25 that you won’t cover until it gets there?
Yeah, was able to load more under $3. I’d say we would be back at $4 or $5 before the end of the week. We could go much higher depending on how many shorts and naked shorts we have left at the end of the day today. I trust Dr. Seethamraju and Dr. Rahman to be really effective at the conference call later today, provide the confidence with real data, and eventually bring us home.
I predict we have an epic short squeeze tomorrow or rest of the week! AF and his buddies are irrelevant in this day and age. They in fact galvanize the troops on the other side!
What a gift this morning! Bought more!
I think shorts are succeeding with creating seed of doubts about the CEO and management. I have been in small biotech for way too long and this is the same template they use to create fear and knock the share price down. How can you trust folks that call the company fraud, drug as saline, etc? You all know very well the science and the results have demonstrated that. Think about HIV ph 3 outcome too! Also, NP is going to get us through. He is persistent. His communication skills are not the best, but his intentions are good and genuine. The reality is these things take time and don’t compare CYDY to big pharmas who have 100x resources and experience. Our advantage is we have better science, better product, and so block the outside noise! There are far too many KOLs supporting us and unfortunately COVID will stay with us for years to come, so adding couple of months to EUA in the worst case scenario is ok. Although I do believe UK is going to approve sooner.
Small biotechs (particularly game changing ones that are not easily acquired) mostly go through such manipulations. Don’t let them run down the price tomorrow! It’s clear we will have EUA. Could we have GME like movement this week? We are in a pandemic and this is the only drug that may help critically ill patients, as per Dr. Seethamraju.
With all due respect, I do not agree with this statement:
“The mentioned players outside Brazil will likely not throw shade on FDA by granting EUA”.
I have seen enough evidence recently that UK MHRA will make bold and brave decision, w/o FDA. Just to give an example, I am invested in another company NWBO where it’s clear that UK MHRA is going to approve first. And in fact, the management realizes this and have strategized around this. MHRA and EU were the first one to approve changes in their endpoints too and it’s a slam dunk based on their interim analysis publication!
Can someone summarize what other drugs are approved and/or currently on ph 2/3 for critical COVID patients?
By the way, Philippines said they would take EUA from any major Canadian or European agencies to proceed, not just FDA. So if Canada or UK MHRA authorizes then Philippines will certainly get on board right away. I am optimistic that UK goes first. There will be no BS there!
Why wouldn’t FDA remove OLE and eIND then? And why would they allow them to proceed with another 140 critical patients. If they thought it failed, they would have stopped all of this! Also, I’d expect FDA to come out with a statement similar to what they did recently for Ivermectin, if they didn’t see LL’s potential.
Agreed. We will get there in 3 months! I know this was said before and majority of the shareholders have been patient but this is what investing in small biotech is all about. Lots of DD and trusting the science to deliver. FDA could have easily slammed the door on us if they didn’t believe, but instead they are giving us another opportunity to knock it out of the park! CYDY is not going anywhere. I am confident we will be in double digit in 6 months even if there is some dilution along the way. Who knows we could gap up tomorrow! :)
By the way, the therapeutic market for critical COVID patients is unfortunately not going away for another 5 yrs at the very least. And we will certainly be the major beneficiaries.
Remember this is what Dr. Seethamraju said and he will be part of the conference call tomorrow afternoon!
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.”
AF just released a hit piece on a weekend. This does indicate shorts are super scared and know the science will prevail & win out after all despite some of the errors from management! I’d certainly buy more this week because I know this will be double digit in less than 6 months!
They have statistically significant efficacy and safety data from HIV trial too (close to 1000 patients!). There should be no doubt about safety and mechanism of action with data now from close to 2000 patients considering CD10, CD12, HIV, and other eIND cases.
I always wonder why they allow Dexamethasone? Understand these corticosteroids have been used for ages and are cheap, but it hasn’t gone through any specific trials with COVID patients?