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Misiu143 I hope EU gets LL. It's not getting any better and I hope and pray the people who are in position to help the world through this, give leronlimab a EUA before too many more people die.
https://apnews.com/article/europe-coronavirus-surge-cautionary-tale-for-us-051e996d5b7e31711bb741e2f9ba724f
So why don't they? DSMC is independent of FDA, so just change it and p values will demand EUA. Could NP ask this of DSMC? I thought objective is to save people's lives.
Do you think DSMC would have recommended change to primary endpoint to length of hospital stay if allowed to review at 75%?
I also implored NP to file for EUA in other countries. This evidence for life saving benefit cannot be ignored.
I also put in the body, "please read because people's lives depend on your decision". Maybe she'll think of the people who could benefit rather than BP for once.
I just emailed Dr Woodstock and NP this article. I put in the subject line, "p value not best way to judge benefit". We'll see what happens.
Why couldn't information presented in this article have been in the pr? Very explanatory and pointed. This article should be sent to all medical agencies that NP applies for EUA.
Is there any way this article would be read by individuals who can make a difference? Short retail will call this a pump and dismiss it. I think it is a great example of poor execution by FDA regarding DSMC decisions and another trial is needed to cover their tracks. Bottom line, more people will have to die because of ineptitude at every position of responsibility, sad.
I just don't trust the FDA to look again. Has there ever been any other drug that was told no by FDA that received approval elsewhere?
Misiu143 do you or Rockleo think leronlimab will get a EUA for covid19, or do you think time would be better spent focusing on HIV or cancer? Would you like to see a more medically experienced person as CEO to get us there?
I believe the key words to this are "over 5 years", which equate to an additional 9 to 25 million per year with 30-40% margin.
Share price is key, and one way to increase it is by showing growing revenue, and also having a profit. That could happen in the next couple months. Solid financials, growing revenue stream and profits will put upward pressure on share price imo. Then comes uplisting.
Rockleo, I believe if leronlimab is ever able to reach it's full potential, then NP as you say has to swallow his pride. Yes he is highly motivated as he is the one who sacrificed to keep it going, but he has reached his ceiling regarding future impact. Someone with the medical skill and knowledge has to take it from here, or leronlimab fades into the sunset. I personally feel if NP were serious about helping those around the world, perhaps a partnership for covid19 only might be the best route. If a partner was willing to handle the logistics for a cut of the covid19 revenue, then it might make it to the next level. Until then, I fear that we will listen to weekly CC's with nothing but hope and maybe's.
If revenues that come in next week are what I hope they are, along with increased revenue potential for rest of year, I think it could be soon when uplist process starts. Now with debt gone, and telecom consilidation, it's very likely profit margins will begin to show up. If that happens then institutions get on board and we take off. I think uplisting is no brainer.
End of summer before EUA application? With the time it takes to approve protocol and then actual recruitment, then trial and data analysis, without another country stepping in, would this be a reasonable time frame? How many more people have to die?
Misiu143 how can they ethically have trial? If they know 25% of critical over 65 are saved, how can they say to those on trial, "we know it works, it's just that more of you have to die to prove it to FDA".imo.
How long before CD16 protocol approved? If we have to wait for 140 critical patient trial to get done, it should get started soon. Will FDA try to work with CytoDyn or not?
It doesn't have to be FDA, perhaps NP can grow a pair and approach EU or Philippines. Let EU tell the people dying from the variants, "we don't care that leronlimab's could save 25% of critical, they didn't do the trial right". I think this was a multi-faceted screw up, don't let people die just because trial was ill designed. All imo.
I would love to see a 8k saying an EUA has been applied for. The evidence is there for it regardless of what many say. Was it poorly planned, yes but that's not leronlimab's fault.
Moneycrew, I would like this to be true. I am in the camp that NP is in over his head and his failure to see that really hurts leronlimab. I am convinced however that the science is outstanding, and if the FDA would judge just the results and not the failures of the process, then there might be a chance. I don't understand how the wording "safe and show possible benefit" doesn't apply to leronlimab
Leronlimab is needed in EU now! https://www.wsj.com/articles/europe-confronts-a-covid-19-rebound-as-vaccine-hopes-recede-11615558520
Yes, there are some who are anxious, but the slow and steady win the race. Even these last couple days I've read a few complaining, but let's be real, we are up 10% in 2 days!! Take a breather and enjoy the ride, especially since it was on low volume. When the big boys get on board, then look out. That's all I gotta say.
Again I want to thank you dh. I am a couple years away from retirement, and I believe within that time, this will become my largest holding. Your efforts regarding how much potential income from all the different subsidiaries they have really makes one wonder just what the potential sp will be, even in just a year or two. I will be buying all I can afford until I retire.
I believe you are right. However I think that until we get numbers not just pr's that this will continue. I hate it, but I ain't leaving. Once the money from these different subsidiaries become reality, then we can start climbing for real. With the different projects that have started at the beginning of this year, it may take a couple months for that to happen, and I hate it but sp may become trade bait for shorts.
I believe that something else is brewing as well, however I don't think it will be materially significant. It will be another opportunity for NP to get more "air time" as it were, but sp will still tank tomorrow. It will be months before sp gets back over $5 and only if 140 critical patient trial gets EUA.
Yes, a partnership with reputable BP would be best for shareholders and patients. NP would have minimal impact on sp, and revenue would be assured. With all the talk about potential of leronlimab, if it's not approved, it doesn't mean squat.
With FDA not giving EUA, the problem with leronlimab getting something elsewhere is NP. No matter what is said, his constant embellishments, misstatements and innuendo's give other countries pause as to whether they want to deal with us. Do I think NP has really put in an application for IO with Canada? No I don't, and neither will the investment community come tomorrow morning. The science is beyond compare, but science doesn't get into people's bodies by themselves, they need a company that has their act together and unfortunately for the needy masses, NP won't let that happen.
He said started application for IO in Canada. I wonder if we can count on that being true as the statement saying Mexico was next.
Apparently not
Apparently current FDA members don't agree. Again, more data, it seems to be always the case for CYDY. Another stall tactic.
Why not EUA and enroll 140 and look at results? It's safe and saves lives. Why not get 140 enrolled during EUA? If not satisfied with results EUA can be pulled and we move on to HIV
I have thought all along the FDA would be our biggest obstacle. Do you think that once this next trial is complete that FDA will give EUA? I think not, too much money from BP going into FDA coffers to let it happen, and FDA will try to find some other reason. CYDY is too big of a threat, not only covid19 but all other indications. If by some miracle another country gives leronlimab a chance, then we could see revenue, but I believe FDA will try to stop that as well. If we do have "stat sig" results from 140 patient critical trial, then we may get EUA from FDA and other countries will follow suit. FDA had shown they really don't care about saving lives, rather it's about the money in their pockets from BP.
I'm still holding a core position, but I'm glad I reduced my exposure at just under $6. I will make money elsewhere, and when summer comes, I may get back in if 140 critical patient trial meets primary endpoint.
All those looking to buy CYDY cheap, they will get their chance next week, possibly less than $2. It will be 4th of July before we get above $4, and then if only they have filed for EUA after 140 patient trial, and then it has to hit primary endpoint. What are the chances?
I would like to believe that, however I am very leery, and I believe that the FDA wields a big club and would use it against other countries medical communities if they give approval before FDA. I can see them telling the different countries, if you want funding and research assistance, toe the line.
So according to what Nadar said a minute ago, earliest EUA is 2 months away. 4 weeks for 140 patients to get through trial, if done quickly, then 4 weeks for data analysis, then ask for EUA, if "stat sig". Nadar has said a couple times that FDA would not give EUA because it was not "stat sig". Many people here said "stat sig" wasn't needed for EUA, however apparently it is.
All I know is every time NP talks, sp tanks. To say you know something based on what someone else says, that isn't right. I know very little, especially in the medical field, I know what I have heard from past CC's.
We don't need "color". We need data! Hopefully on severe. NP's "color" has tanked the sp every time he talks. If he would just for once be on the other side of his mouth, maybe he would put someone else in front of the mic.
So you don't know. Why put this out there?
Do you KNOW this?