New SEC 13d filing: I admit I only glanced over this as we are getting new ones just about every week now. What stuck out is that the 13d have paid as much as $1.5 mill already in their fight and stated that they have not ruled out asking the Company to reimburse them! That’s Cheeky!
Also, BP said he only asked for $150 mill for IncellDX but because of the depositions going on, it has come out that he has some Milestone payments tucked in the offer that would have paid up to another $200 mill. Sounds like Nader WAS correct when he said BP wanted $350 mill and BP was very misleading as he spoke. I see support of 13d starting to fade. IMO

This is fantastic news Misiu!!! My continued prayers go out for your son.

Poor argument. Questioning ownership in a company that the new board may use our money to buy is relevant. If the current board or Nader start thinking about buying another company I would most definitely want to know if they had shares in said company. Sorry that you can’t see the difference!

Question about Compensation: I have not decided one way or the other about the 13D proposal of replacing the board completely, partially, or not at all. There is still TOO much time for things to develop before I commit to anything. However, I would like to know how many shares will we have to give up to new board members, officers, and CEO. Is it a million shares, 2 million, 3 million? Anyone have an idea? I don’t like the idea of any dilution but if it helps the company cross the finish line then I may be open to it. Of course no one can guarantee results either way but new officers and even board members will surely make out well regardless.

People don’t want something until they need it. People don’t want Leronlimab, probably never even heard of it, because they don’t have Covid in an ICU, so they don’t need it. WE all know about LL and it’s possibilities, and we want to save lives, but most of us came here because of the investment too, so we need it (the EUA). I think the LongHaulers will change all of that. If successful, and all indications are that it will be, we will be joined by an army of people who “need” it. And they will become the stronger voice of CYDY. Hopefully their need for a better, more normal, healthy life, will be the pressure we need on the FDA to approve this drug. I look forward to hearing the results, even if just Phase 2. IMO

Getting the same

Touché Learning!

Well said Stockorus

Shareholder meeting is in Aug/Sept. It appears that more and more people are ready to see management changes. Most likely won’t happen until then. So they are all on notice and will have to step up and produce some kind of results by then or they will possibly be voted out. So can we please give them space to do just that. I don’t believe it is in the best interest of the Company, nor stock price, to bash them all the way until August. There will be plenty of time for everyone to opine their grievances in the weeks leading up to the Shareholder meeting. So if you are an investor, and want Nader et al gone, please hold your rounds until we get closer to the firing squad date. For the sake of the company, the stock price, and your investment, please don’t come here bashing everyday. It does no good and we already get it…you want Nader gone! IMO

Enjoy your day!
And yes I think we all have an addiction to this board as we eagerly wait for LL to break out.
Happy Mother’s Day

I found this to be a positive CC. We all want to hear Breakout news, and those don’t just come because we want them to and not when we want them to. If we believe in the science behind LL then the news from 28+ will be strong and the order for more will come, especially when the 400 vials we gave for free run out. The TV interview with Dr. Nichols should be good news and good exposure. Hopefully more Long Haulers will speak up about their experiences as well. Patience is a virtual well rewarded! IMO of course.

Well, you asked for a PR! Here they come

Cydy seems to check off a few of the boxes

https://www.griproom.com/fun/10-signs-your-company-is-about-to-be-acquired

Sorry Daemon, meant to start as new post and not tagged to you

The problem with getting a new CEO is that he/she would be coming here to either make a name for themselves, make a ton of money, or to use as a stepping stone to bigger and better things. A new prospective would be refreshing but there is no way that person would have the same passion for the company and drug as Nader. That new CEO would be more likely to sell out the company for a lackluster amount to secure his/her spot on the board of another Big Pharm company. I certainly don’t know which would be better. But: Be careful for what you ask for.

Thanks Bluefish, looks like 5pm on 28th (not sure of time zone), should be interesting, looking forward to it!

Dr Kelly was suppose to present at a Cancer conference on April 28th I believe. Does anyone have info on which conference, where, and exactly when?

Misiu, here is a good article showing bioavailability of Pro 140 done in 2010

https://pubmed.ncbi.nlm.nih.gov/20377413/

It shows a rapid uptake after injection to 1ug/ml within first few hours with further increase to about 10ug/ml by 24 hours and max levels of 10-11 ug/ml by day 3-4. So I would conclude that total absorption make take 50 hours but that you achieve almost max serum levels by end of 24 hours.

I tried to post a picture of the data but was in able.

Misiu, I would love to see this article, as a physician, I have never heard of any subQ injection, especially one that can cross the blood brain barrier, taking 50 hrs to be absorbed into the blood stream. Surely there are bioavailability studies from the HIV trials that show this. It is reported that LL is a large molecule and perhaps that could slow the absorption rate, so these bioavailability studies would be helpful. Also, there were patients who showed positive results as early as 12 hours. Perhaps the calming of the cytokines storm and restoration of the immune system may take up to 50 hrs. But I am curious to see the articles you reference, if nothing else but for my own continued education. IMO

https://www.philstar.com/headlines/2021/04/14/2091139/erap-moved-regular-room-after-testing-negative-covid-19-jinggoy

“He added that Estrada is still on oxygen support but “no longer high flow and only by nasal cannula.””

Please put this to rest!

He is out of ICU and on regular flow nasal cannula oxygen.

mldillon, couldn’t agree more. As a physician I have watched Fauci tell misleading info and blatant lies over the last year. From “masks don’t work”, to moving the Heard immunity goal posts. And back in the ‘80’s, while he was concentrating his work on HIV, he was very narrow minded in his studies. To me he clearly has a Political motive to his agenda. While his “bend the curve” plan was correct in my opinion, his desire to mitigate everything until there are no more Covid cases is moronic. The damage that his mitigation has done to the country is horrific and will be felt for years.
IMO

If anyone needs another reason to pray that LL helps for the Long Haulers, go look at some of the posts on a FB page set up by LH: “Survivor Corps” (over 150k members) These are real people and OMG, their lives have been turned upside down. I hope LL is the drug that helps them, but I would still be happy to see ANY drug bring relief to these folks. Prayers for them all!

Hindsight is 20:20. Maybe we should have unblinded at 50%, would have cost us some in p value but then maybe we could have tweaked the trial and endpoints. We would at least have had a realistic ideas of what the results would be.

Rock, that’s a damn good question! Furthers my belief that the FDA is yanking our chain. If we have valid proof that LL suppressed viral replication by entry inhibition, why do we need to show receptor occupancy when Mavoric did not?

Absolutely agree! Would love to see a well written PR about our TNBC and Basket trial updates every now and then. We have so many things going on with LL and need to PR the great progress we are making. PR the NASH updates, the Long Hauler trials, etc... Positive news pushes SP up! (Hint, hint NP)

I agree Jimmy, we haven’t crossed the goal line yet but I believe we will. We should be able to hit our end points in this next trial based on the numbers from CD12. I also think it would be prudent for NP to make a deal with Philippines, Brazil, etc... and sell LL at a discount for being the first country to approve us. But beyond Covid, there is nothing working in TNBC and to have the results we have is just remarkable! I know we have multiple indications we are shooting for and eventually HIV will be lucrative, but I agree that we may become best known in oncology because we will be the only drug making a difference. I bought more today and look forward to when the test results start coming in and this thing takes off. IMO GLTA

I watched the newscast on KOIN tonight. Not much info given, NP basically said “we are determined to get this drug to market for the indications......”
Was very matter of fact, sounded confident but not exuberant.
Perhaps tomorrow KOIN will post more of the video.

Emergcy, you are correct that LL would help to prevent you from getting HIV as it blocks entry to to the cell. As for Covid and Cancer, it doesn’t work that way. You could still get Covid, the inflammatory response would be mitigated, so you would recover more easily. As for cancer, it doesn’t prevent cancer, nor does it kill cancer, it helps to prevent metastasis of cancer cells. But obviously those benefits would come to any one taking LL for which ever reason.

SmileyRiley, I have thought this all along and hope the company has collected the data. Many patients are in the hospital for weeks/months before they succumb to the virus and its inflammatory effects. Carrying out to 42 days will only help prove LL’s worth IMO

Don’t know if you have been answered yet, but the BLA is for full approval. What we are looking for with Covid is an EUA. The Emergency Use Authorization is not a permit approval. For that you will need BLA. IMO

Great news, but why wait until market close to put this out? It’s a Friday, this great news will have little impact on stock price come Monday morning. Midday release could have given the SP
A little more of a boost. Just my opinion

Short squeeze happening to Dillards, Bed Bath and Beyond, and Ligand Pharm.

Your logic is flawed. You assume that the placebo group stays within their (your) defined group of mortality rates. In fact, the critical/excluded group with the higher mortality had passed thru the lesser mortality rate group on their way to the more critical group. They obviously would have been part of the sever/critical group that could have been inserted into the trial if they had the chance to. The placebo group no doubt had recoveries but they also had progression into a more critical/excluded group, and then unfortunately would have the greater than 32% mortality. Leronlimab’s challenge is to keep the severe/critical group from going into the more critical group that would have the higher mortality. This is where the results will either show LL works or doesn’t.
So your inference that the Plcebo group would have a lower mortality rate is clearly flawed.

As both of us know, the vaccine will mitigate the progression of the disease, not your ability to catch it. Even though you get the vaccine you can still get and transmit (although at a much lower viral load) the virus. So those 12,000 tested positive, I didn’t see that they became terribly symptomatic. I do have reservations about the virus and believe we will learn a lot more after millions get inoculated. I wasn’t going to get the vaccine but when some of my colleagues got very sick with the virus I went with the Pfizer shots. Now I have peripheral neuropathy in both feet. Not progressing so hopefully will resolve. Much to learn bout these new vaccines!
GLTA hi

Bwolfy, I disagree about time line on CD-12. The DSMC asked for the 42 day evaluation on Interim analysis. The original trial was for a 28 day evaluation. I don’t think we are obligated to wait 42 days to unblind the Data if the trial is over. And we shouldn’t! Unblind the data at 28, while still collecting data up to 42 days, and let the world know about it. There shouldn’t be any “point” deductions for following the original trial guidelines. IMO

My 2 cents: the Board of Directors and Nader have blown it. The ridiculous Press Releases that fluff the situation and then never deliver, the incompetence of filing BLA with FDA and then to lie about it and say it was only three things that were easily fixable, then to hold a vote to line their pockets (whether they thought they deserved it or not) has all led to loss of faith from the investors. My physician colleagues have had it with the promises, lack of delivery, and delays from Nader and most have sold their shares and took their losses. He has been played by the FDA/DSBM probably at the behest of Big Pharm.
The FDA giving Lily EUA for mild to moderate is a perfect example. Perhaps if we had an aggressive PR firm that gave the public our results in a strong positive way, we would have been the EUA MaB for M2M.
And now Nader and the boys are being played again by FDA. If our drug is any good with Severe to Critical, that data needs to be released. People are dying and if we can decrease mortality by even just 20% we would be saving thousands of lives. And the Public needs to know it. They will put pressure on the FDA for EUA. On the other hand, like RockLeo has said, if Leronlimab does not have a positive effect on S2C and does not decrease mortality, then rip the bandaid off and quit the charade. Move on to concentrating all efforts into HIV, cancer, and NASH. UNBLIND the damn results!!! For 1 point deduction? That’s a no brainer, take the point loss. If the drug works like we all think it does, we can withstand 1 point. If we can show 30-50% reduction in mortality, with a good PR push, the world will DEMAND the drug be released, if only at EUA status.
Nader has flubbed up a lot, but now he needs to man up and push the drug across the finish line or drop the whole Covid idea and start lining up trials for Cancer and NASH. With the Ridiculous requirement from DSBM to track pts to 42 days post treatment, we are being played and the FDA will find one or two other MaB to give EUA to. UNBLIND NOW! In my humble and upset opinion!

I agree completely with you Rock! If you look at what is going on across the World, the infection rates are going up but the Mortality rate is actually going down. Is this due to better care (maybe) or is it likely due to the virus attenuating (more likely). Therefore, the most significantly significant difference between Leronlimab and the SoC will have been seen already. The longer this trials goes, the more people will survive SoC. That’s great news for the world, not so great for Leronlimab. So losing a point in the p value now means nothing compared to getting the drug data out now and pushing for approval. Not only will Leronlimab save lives now, but will hopefully prove effective in Long Haulers. I think NP and the BoD are making a grave mistake in not unblinding the Data now. If we have a 20-25% improvement in mortality (and that is a low ball estimate in my opinion) no one is going to care that the p value was increased just because we unblinded the data to get to the truth.
UNBLIND NOW!!! IMO

Sounds like he got 8mg “cocktail” monoclonal antibody. That lines up with REGN-COV2
Hope it works! Wish it would have been Leron

Regeneron CEO just finished interview on CNN talking about was basically their Mild to Moderate study of 295 pts. This is how you get your name and brand out there. NP has failed us in this respect. I don’t think Regeneron is anywhere closer than we are in testing but they will probably get a nice bump tomorrow and we won’t. The FDA will probably favor them just because of the publicity IMO. VOTE NO!

Unbelievable: approval for EUA for mild/moderate was never submitted, just asked about??? If we are waiting on Severe/critical Interim then WHY waste any more money to run a Phase 3 for Moderate??? If it gets accepted for S/C it will be used for Moderate at the discretion of the physician. Why pour more money down that Rabbit hole when we won’t get any results until well after S/C interim is done. IMO

Maybe best it wasn’t Leronlimab. Trump wanted this as a political win, Mainstream Media will do everything possible to keep that from happening. Especially since Trump slammed FDA for slow rolling