Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
looks like EUA - 25usd
This is the most frustrating stock. But the one thing I've learned over the last 9 months is that the stock price will rise as soon as all hope is lost. It truly feels like weak hands are being shaken out intentionally.
Nader is bashing HGEN because he fears HGEN.
An EUA will solve everything. And nothing has changed on that front. Covid trials in general have done poorly. Covid trials have done especially poorly with the advanced stages of Covid. There is currently no good treatment for severe patients. No other severe drug is close to finishing a p3 trial. With a trial meeting its primary endpoint and no other good options on the horizon for severe patients, an EUA is automatic.
The FDA will love giving an EUA to Small Pharma. HGEN was also the token Small Pharma to get government funding for trials early on.
Searched around Health Canada on it's drugs under review and approved links. CYDY's drug is no longer on the under review page, and it's not on the approved drug list page.
Meanwhile HGEN is getting together an EUA that will sail. Hold on to your butts.
This would be a good time for a short attack.
95% of all those securities class actions are nuisance suits fishing for a settlement. They rarely amount to anything.
$4.00. I can't believe it. Congrats.
Majority of the patients in the Lenzilumab study , I believe about 60% had about 94% oxygen ,
on low flow on oxygen , thats it
These are moderate to severe .. those are not the “ very sick “
Lenz is used at the beginning of the severe stage. It is when a patient is going to stay in the hospital in the ICU. That is "very sick". Criticals are more than "very sick". Criticals are on the brink of death.
And only lenz is going to be talked about in a few weeks. Leronlimab is starting a new trial.
The below quote is from Nobel Prize winner Dr Robert Gallo. He co-discovered HIV. The interview was published in the Baltimore Sun 2 days ago. It sounds like he is talking about lenzilumab since lenz treats severe patients right when the inflammatory stage is starting. But it is possible that he is talking about aviptadil. But yeah, it's lenzilumab.
https://digitaledition.baltimoresun.com/infinity/article_share.aspx?guid=6282634a-ad9c-4a67-ab51-92801115a6f9
There’s a new anti-inflammatory drug coming. It will be a breakthrough, and I don’t say the word breakthrough often. But this is something that will be lifesaving for people who are sick with the inflammatory part of [COVID-19]. It’s a few weeks away from being openly talked about, but I promise you it will be a lifesaving therapy. It’s going to help a lot of very sick people.
The below quote is from Nobel Prize winner Dr Robert Gallo. He co-discovered HIV. The interview was published in the Baltimore Sun 2 days ago. Since he gave a timeframe of a few weeks, I think he is talking about lenzilumab. But I have to admit that it is possible he is talking about leronlimab. But yeah, it's lenz.
https://digitaledition.baltimoresun.com/infinity/article_share.aspx?guid=6282634a-ad9c-4a67-ab51-92801115a6f9
There’s a new anti-inflammatory drug coming. It will be a breakthrough, and I don’t say the word breakthrough often. But this is something that will be lifesaving for people who are sick with the inflammatory part of [COVID-19]. It’s a few weeks away from being openly talked about, but I promise you it will be a lifesaving therapy. It’s going to help a lot of very sick people.
That Dr Robert Gallo quote has to be about lenz. The timeframe and description match perfectly with when lenz is used and when an EUA is expected.
please explain why HGEN has your confidence and CYDY doesn't?
Ceo and cfo already parachuted
Well actually maybe the same study was done with Remdesivir .,
How otherwise Gilead will know to change in the last moment primary endpoint to length of hospitalization , the ONLY positive finding in this study ..
How did they know ???
https://www.nih.gov/news-events/news-releases/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19
Preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery than those who received placebo (p<0.001). Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (p=0.059).
because HGEN did adaptive design of their study , where management knew results of the trial , during the trial..
To meet Statistically Significant primary endpoint in this situation has no value ..
It only show how nicely they followed the results by changing primary endpoint to accommodate their real life results..
It tanked BEFORE the offering.
just knowing what little i do about you from this board
There is no reason for HGEN to tank after announcing ground breaking news
Hgen has nothing except a small hope for a IV use in covid-19, if they fail at that back to .20 cents. It’s already been proven today’s hospitals and DR’s barely use IV infusion drugs as they are complicated need extra staff and hospital rooms, 80% of infusion MAB’s sitting on shelves
CytoDyn has not released their CD10 data. They will not release their CD12 data either. My guess is that there was a higher mortality percentage in the treatment arm than the placebo arm for the whole trial. But we will never be given that information.
HGEN has STATISTICAL SIGNIFICANCE with their PRIMARY ENDPOINT for the WHOLE TRIAL. The primary endpoint they ended with is the same as they started with. They haven't released any data on subgroups. Because their data is superb on the whole trial.
For those starting their due diligence on HGEN, the below links explain how GM-CSF is the cytokine responsible for the cytokine storm, severe Covid and death. HGEN's drug, lenzilumab, is a GM-CSF inhibitor.
https://www.bbc.com/news/health-56352128
https://www.dailymail.co.uk/news/article-9346955/Blood-test-spot-Covid-patients-high-risk-dying.html
https://immunology.sciencemag.org/content/6/57/eabg9873
2 PRIMARY ENDPOINTS , not one from the beginning
, and missing the second one
management knew the results of the study all the way..
Just listen to the last CC , I did.
Easy to find the primary endpoint , if one know results of the study ,
I am really surprise they needed to change primary endpoint 3 times..
they need very little to get EUA , they know Gilead and Dr Fauci personally.
I really don't understand how people can believe that leronlimab will get an EUA at this juncture. It is literally a 0% chance. That 14 day mortality for critical patients is reason for optimism. It easily justifies another trial. The FDA already told CytoDyn to do another 140 patient cohort. No EUA right now. Anyone who says otherwise is either a paid promotor or daft.
Remdesivir's interim analysis started on April 22nd. Fauci's press conference saying rem would be the standard of care came on April 29th. Sometimes things happen quickly.
There are some GREAT treatments....just not FDA approved.
HGEN getting EUA in two weeks ??
You have absolutely 100% no idea who this congressman's connections are.
Did they release the 60 day mortality numbers for the whole trial?
whether or not the FDA recommends a 60 day mortality endpoint for the critical population
CytoDyn's 1.3 million vile inventory
Stat sig is harder to show lower the n
https://www.ama-assn.org/delivering-care/public-health/fda-experts-discuss-covid-19-therapeutic-clinical-trials
I think at the beginning of this pandemic, we didn't know enough about the disease and its heterogeneity.
For example, monoclonal antibodies, which I was very involved in getting them developed and studied, we took all-comer outpatients and we should have realized that most of the people get better no matter what you do. Treating them with a monoclonal antibody was a dumb idea because it's very hard to treat people. It's expensive and yet they were going to get better on their own and make their own antibodies and they do just fine.
We did very large trials, and yet we only had a very small event rate of hospitalization, and so more trials had to get done and those didn't get into the clinical guidelines and everything until later because of those definitive trials. I think many of the smaller trials were because people naively assumed this was kind of a monotonic disease and we could study like 400 people and that would be really a lot of people to study. That was completely wrong.
use of the drug only for severely ill COVID-19 patients
Philippines, Brasil, Hungary. Duterte, Bolsonaro, Orbán. It's a rogue's gallery of corrupt authoritarians.
Sounds like he spoke to someone at the FDA that knows Leronlimab well.
Representative Rodney Davis has zero influence with the FDA.