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Dr Rahman not listed as participating, and no BLA for HIV update listed either. I hope this doesn't mean bad things. I so want this to not be another CC like we've had in the past.
That's the point. If NP had kept the original CC date and time, there wouldn't have been much expectation. However by postponing it for a day, and if it is only "another update" it feeds the narrative that NP is giving false hope that there was something substantial and lends credence to the many lawsuits. I do hope that there is something meaningful, like a partnership for covid, or even a limited EUA with a phase 4 in Brazil or Philippines, although I doubt that. Otherwise I think sp will go down to the $2's or lower again, and will stay there much longer as nobody will have any faith that NP knows anything about being a CEO imo.
Do you think other countries who haven't had a bad experience with NP might give EUA?
C-20 do you think anything other than a EUA of some kind will prompt shorts to jump in hard to push sp down? If EUA of some kind I can see a lot of manipulation being tried, but a lot of buying pressure as well imo.
I did not realize it is illegal for FDA to have vaccine if there is a treatment, what does this do for leronlimab?
https://www.bitchute.com/video/i3rlgX5MtyfK/
I'm afraid anything short of EUA announcement in morning PR, it will fall imo. If no pr, I fear it will fall hard back into the 2's. The shorts will jump all over the stop loss limits and push it down. I'm still here until we receive revenue from somewhere, as it may take 6 months to a year, but I can wait. I still don't think that NP understands what the investment community is looking for, and his idea of news has not coincided with the expectations. I pray I'm wrong, but I don't expect so, either way I'm here for the long haul.
I believe if there is a EUA from FDA with phase 4 trial it goes higher than that imo. I believe that orders will flood in from other countries and Samsung will be busy making more leronlimab.
I was blessed this morning. I had intended on adding 10k shares, but I was able to add 11k.
I think that with a IO from Canada, it won't move much. However if Philippines or Brazil use that as a justification for them to ok it, then look out because many more will follow and sp could hit $40-$50 in a few months, depending on how many countries place orders. Then of course you have US FDA if they give EUA, no telling then imo.
I will buy 10k shares more Monday morning. All the negativity has convinced me great things are about to happen, and since what I have is "on the house" since I sold enough just under $6 to cover costs, I cannot afford not to increase my position.
Dieselpro I agree. This has been circulating long enough, that if there was some false information included in the letter, the congressman would have issued a statement refuting it.
If he was able to say that now, I have a feeling we see some kind of announcement before Monday morning. I think unless a time frame for a public release had been set, that this would not have been communicated to him, imo.
If this is true, and I expect it is, would other countries be limited to s/c patients as well? I believe leronlimab would be best for recovery if administered a lot sooner.
I sincerely believe the moa and efficacy is the main hang up. I know the FDA is just starting to understand precision medicine, and I think leronlimab will be given EUA, but with phase 4 confirmatory trial requirement just for future approval, all imo
It's the efficacy of the drug.
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-inmazeb
There were less than 400 total in trial, yet they got approval. If the need is great, I believe FDA will consider it.
C-20 outstanding argument!! There will be many here who will try to refute what you stated, but it is the truth imo. I think the results have shown to be so much better than anything else, that perhaps the FDA is just trying to wrap their heads around the implications. If the FDA doesn't give EUA, something is wrong imo.
I think that 82% is great, I just think because of sample size, a phase 4 will be required for future approval. I also think it would be good for other countries to see this, so they would be more willing to give EUA, knowing that there is this confirmatory trial ongoing.
Thanks Dieselpro. EUA with phase 4 confirmatory trial with additional 2 shots should be the next course of action for FDA.
Could FDA realize their mistake and give EUA along with phase 4 with 4 shots to cover their behinds, so people will be saved? Or do you think leronlimab gets the runaround again and is told to do cd16 and cd17 with 4 shots and placebo arm?
No placebo mentioned in pr extension. Just additional 2 doses, for total of 4 over 28 weeks. Hmmm.
Will FDA withhold EUA until cd12 extension with 2 additional doses is completed? The pr states immediate EUA is being pursued in multiple countries, what is the possibility that they get it with trial ongoing. Who would be willing to enroll in trial unless you knew you would get leronlimab?
Is the DSMC independent of the FDA? If the CD10 trial was initially proposed with 2 doses and CD12 was proposed with 4 doses, why would the FDA push back. I would think that it if you're in the hospital on ECMO you would need more medication than those who possibly are close to recovery. To me that is disturbing that the FDA said no. Then during the Oct 20 CC it was revealed that it again was proposed to the DSMC to adjust the dosing, and they said no, just have a read out at 75% of enrollment. I thought that the object was to save lives and what dosing it took to do that. I really hope that the FDA is not as biased as this appears, if so then a EUA will be very difficult to achieve imo.
https://www.upi.com/Top_News/World-News/2021/03/28/coronavirus-brazil-record-setting-deaths-cases/7761616938253/
We all know about Brazil, I would hope that people in charge of healthcare are given the opportunity to give leronlimab.
https://www.foxnews.com/world/france-to-close-schools-ban-domestic-travel-as-virus-surges
Leronlimab is needed all around the world, I would hope the FDA would see this, and give EUA, perhaps even if they think USA doesn't need it right now, but the rest of the world does.
So question arises. If BLA for HIV is filed this year as mentioned, how much will will be asked for? Can Samsung keep up with demand? Then there is cancer and NASH.
How would approval for long haulers factor in?
"Would be a huge benefit" I would think that it imposes a condition for the future and not the trials. Remdesivir was allowed to dictate the dosage levels, and leronlimab was not. Isn't that said when I said they were allowed to dose as much as they wanted?
I didn't say unlimited, I said what they wanted as they saw fit. They first said 5 then said up to 10 days. Leronlimab was not given the option for more than 2 shots, even though they asked. It seems obvious that if you are given a shot that when the 1/2 life expires, and it is of benefit, then you should be allowed to receive more. Again the object is to get well, and what dose allows that.
I didn't say people in a trial, just those in the hospital now. The trial indicated that taking more than just 2 would be of more benefit, as the 1/2 life was substantially shorter than 28 days. If you can't see that, then you are denying the obvious and have an agenda of enriching yourself at the expense of people's health. I feel sorry for you if this is the case.
“Remdesivir was allowed to dose as much as they wanted.
So with 5-10B what would sp look like? How much of that would be actual income? How hard would he shorts try to keep it down?
I'm just very concerned that FDA may want us to jump through hoops in the CD16 and CD17 trials. I have always felt that FDA had the better good of the people in mind, until I became a biotech investor. Now I realize that like everything else money reigns imo. People on this board have said that FDA will approve because if they don't, many people will die needlessly. I now realize that it doesn't matter because many people have already died needlessly, and all that is screamed is they didn't meet primary endpoint. Don't people care? It's very plain that leronlimab would be a huge benefit to those who took it, especially if they were allowed to receive it until well. I work in the electrical contracting field, and it's all pretty straight forward. Either you get the job done or you don't, you can't lie about it, and if you do a poor job, you're fired.
If multiple countries give EUA, what could be income and where will sp go?
Dieselpro, you mentioned $18.50 as the price target after EUA. What do you think happens if multiple countries do the same in just a matter of weeks?
I'm not saying "dicing samples" I was responding to djjazzyjeff who stated that the sample set couldn't be relied on because it was only a subset. I feel that all of the critically ill were under consideration, just that it didn't include the severe, which probably were less likely to die anyway. I plan on buying more as I tomorrow as I sold other shares today to free up some money. I believe this will take off in less than a month imo.
Again I would like to ask why would FDA not let CytoDyn give shots for the 3rd and 4th time, if the 1/2 life was known, up until day 28? I would think that saving an individual from death would be part of the protocol imo.
The pr just said for those "critically ill". It doesn't "dice" up any numbers age wise, or those who are diabetic or have other issues. Why do you say dicing the samples?
Thanks, so for those who say it didn't meet any endpoints, this proves them wrong. Would this put extra pressure on FDA since meeting a mortality endpoint with such numbers, I would think they would have to notice, especially since it is so safe.
Was mortality at day 14 a secondary endpoint? It is not clear in the pr and I just heard that it was. Is there someone who can clear this up for me?
Yes, it will work for a while when the volume is low, but I believe once the 10q comes out for the 1st quarter, I think that there is net income. As the pr said, they expect over 2 million in cash reserves at the end of the quarter, and I am expecting them to say they plan on having more next quarter. I think that will increase the volume substantially, as people will have FOMO and shorts will have to cover and run to another company to short imo.