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Completion of Phase 3 study of Bucillamine in Q2, 2021
As I recall that discussion was for 42 days, not 60!
The delay is so long that it has to be because they are looking at the 60 day mortality data. The 28 day mortality data likely isn't optimal. They would have pr'ed it weeks ago if there was stat sig with mortality at 28 days. There might even be a higher percentage of mortality in the treatment arm than in the placebo arm. That is what happened in RLFTF's trial despite amazing anecdotal evidence from their eINDS. Their trial ended up with 34% mortality in the treatment arm and 30% mortality in the placebo arm at 28 days. So now RLFTF is looking at 60 day mortality and praying that trend reverses. I avoided RLFTF's binary event and CYDY's upcoming binary event by going into HGEN. HGEN is starting that honeymoon period before trial results where the stock price melts up. The same gains as a binary event without the downward risk of a binary event.
He’s well aware of the Blockbuster potential of Leronlimab
Has management said how many people are enrolled? If we haven't even had the interim analysis at 210, it is going to take forever to get to the full enrollment of 1,000. It seems like it should be a super easy trial to enroll since you can just give someone a pill to take home. I'd take it. I wonder why doctors aren't encouraging their patients to take it?
Hoping it ok with Nomis that we get back up to the yearly high or better soon. Just a matter of when.
Is it Monday, yet?
I came here for the Psychadelics
Next week is going to be fun! $30 for sure. $40 possible. $50 in the realm of possibility.
The release of the study results and how it was hodgepodge at best as it was so discombobulated!
the inability of Dr. Pourhassan to balance his checkbook in the 1990s!
In the release by neurorx & relief therapeutics, the mean Hospital stay decreased by 11 days. Instead of 26 days, patients were discharged at day 15. You can read the release on relief therapeutics website. If you haven't read the release, then you should to learn the facts from the clinical trials.....
Among the secondary efficacy endpoints evaluated in patients treated with High Flow Nasal Cannula (HFNC) therapy and with Mechanical Ventilation, ZYESAMI showed an advantage in 15 of 16 comparisons and demonstrated a 40% or better advantage (hazard ratio <0.7). The likelihood of this magnitude of advantage being seen by chance alone is about 1 in 2,000 (P=.0005). This difference includes at least a five-day median reduction in hospital stay. (P=.043). The largest difference observed was among those treated with HFNC who experienced a median of 11 fewer days in hospital (15 vs. 26).
Dr. Javitt said: “The data provide preliminary support for ZYESAMI as a drug that may help get critically-ill patients home to their families sooner. The hospitalization data further suggest that patients treated at an earlier stage of illness (i.e., those who can be managed with HFNC) may have a better response to treatment. We have launched a phase 2/3 trial to explore ZYESAMI’s inhaled use in patients who are not yet in respiratory failure.
Big Pharma might have a bad reputation but I have gained respect for them since investing in Small Pharma. Big Pharma does trials with a lot of patients and does them quickly. When the results aren't good, they move on. Small Pharma never moves on. They always lie or misrepresent when trial results are poor. If RLFTF did tell the truth, they would go from being a company with a one billion dollar market cap to worth virtually nothing. So they continue the charade. They released a confusing pr that cherrypicked some of the good data while ignoring or dismissing the bad data. They will keep dangling a different carrot to keep you invested. There are CYDY investors who are still claiming that their mild-to-moderate trial was a success because a secondary endpoint or two out of 60+ secondary endpoints had stat sig. Cherrypicked topline results were released in July. They still haven't released full data. Many CYDY investors won't accept that the trial was a failure even after 7 months. How many of you will still be claiming this trial isn't a failure in 7 months?
The trial, despite it's size, reached a statistically significant reduction in hospital stay with a p value of 0.043
GL To All of Us! Big or Small, All in or 10% in lol!
So what makes the most sense is to expand the trial for only those treated with HCNC and change the primary endpoint to reduced hospital stay. The trial as is has zero chance at an EUA. The trial would have needed spectacular results to get an EUA with only 195 patients.
where do you see that "It decreased hospitalization by 10 days for one subgroup" ?
https://www.neurorxpharma.com/press-releases/neurorx-and-relief-therapeutics-report-initial-phase-2b-3-study-results-demonstrating-significant-benefit-of-zyesami-in-reducing-hospital-stay-among-patients-with-respiratory-failure-due-to-c/
The largest difference observed was among those treated with HFNC who experienced a median of 11 fewer days in hospital
HGEN is a stock that can be up $30 to $50 in a day!! IMO
When are HGEN trial results expected?
Any doctor will want zyesami. It worked better than the standard of care. Plus decrease hospitalisation by 10 days!
I would be a little more cautious than that my friend. Never go 100% anything.
Even when I say all in, it's really like 50% at the most.
Be careful bro but I do like it a lot here...
Zyesami will be in the I-spy covid trials. a clinical trial ordered by the department of health and human services & defense department. It was posted by dmsrz on this forum today. Read his informative post & learn more about this drug.....
mine which are based on facts and DD
You clearly don’t understand statistical power. The point that it DID show significance on such a small number is not a problem, rather that with more people it is almost likely to become even more statistically significant
I think the odds are very much in favor of them receiving EUA based on the EUA history with Remdesivir.
Since you announced today that you now have 100% of your portfolio in HGEN, your bearish tone on RLFTF is to be fully expected!
Once/If a EUA is granted
Already have. Many others, like MWM, are heavier than all of us and it's still not everything!
Back in the green. This stock sure does test one's mettle. But the one thing I learned is to not sell when things get bumpy because that is when it explodes. This stock will skyrocket as some point before results are released. It is just a question of when.
COMMON STOCK 2021-02-11 S 550 d $21.01 5,871,593 direct
COMMON STOCK 2021-02-13 S 16,423 d $19.68 5,855,170 direct
I will be disappointed if the share price doesn't go up at least 50% before trial results. RLFTF and CYDY both tripled in stock price in the leadup to trial results. HGEN is next.
With EUA, what's the pop? 50%? More? Less? Looking at other stocks, 50% seems about right.
Dr Javitt sounds like a man defeated in the Dr Yo interview
The anecdotal evidence is what tells you that a therapeutic works
Or HGEN is selling $100 million of stock, day by day, in an ATM offering where they are not allowed to smooth out the stock price effect.
Today's drop is probably because of Eli Lilly getting an EUA for its mab cocktail. Eli Lilly's drug is for moderate cases so it isn't in competition with lenzilumab. But a lot of investors don't know the difference. This is a nice opportunity for people to buy sub-$21. It will likely be the last time it is possible.
Both are very cult like. Some may die with their shares.
It's going to be interesting to see how many ex-RLFTF and ex-CYDY investors switch to HGEN as their trial results are less than optimal. While RLFTF investors just lost a lot of money and CYDY looks like it'll soon be losing a lot of money, both groups have made a ton of money before their poor trial results. I don't think they'll be afraid to invest in another Covid play. However, they might sell before trial results are released due to their previous bad experience.
And I mean everything and there is still no negative side to this drug.