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It's common knowledge the half life of leronlimab is about 10 days meaning that the effect of the drug would have been much less at day 28. Thanks for pointing that out and why this trial will have a much higher success rate. This will leave the other failed MABs like HGEN's in the dust.
The treatment with leronlimab was only for two doses (day 0 and day 7); from day 14 to 28, the survival rate declined from 82% to 30%...
You're confusing "completely absorbed" with showing improvement. Many patients have shown a positive response within hours. It doesn't need to be "completely absorbed" before it begins working. lol
CytoDyn Receives Clearance from Brazil’s FDA (ANVISA) to Commence a Pivotal Phase 3 Trial in Critically Ill COVID-19 Patients with IV Administration of Four Doses (700mg/week)
https://www.cytodyn.com/newsroom/press-releases/detail/560/cytodyn-receives-clearance-from-brazils-fda-anvisa-to
The new clinical trial will focus on hospitalized COVID-19 patients in critical condition who require mechanical and invasive ventilation or Extracorporeal Membrane Oxygenation (ECMO). The trial will be carried out across 22 research centers with a total of 316 patients. An interim analysis will be conducted after 40% of the patients have been enrolled and have completed a 28-day trial. The first goal for this trial is to enroll 127 patients as soon as possible.
The Academic Research Organization (ARO) Albert Einstein Israelite Hospital (AEIH) in Brazil will conduct the trial in coordination with CytoDyn and BIOMM, the Company’s exclusive partner for the commercialization of leronlimab in Brazil.
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented:
“We are excited about this news and what it means for leronlimab’s potential ability to successfully treat critically ill COVID-19 patients in the future all over the world. We believe the IV treatment in this trial will have an enormous advantage over treatment via subcutaneous (SQ) injections, which was the route of administration in our last COVID-19 trial (CD12) in the US.
Absorption of leronlimab into the body occurs within one to two hours post IV administration. In contrast, SQ injection could be two to three days before leronlimab is completely absorbed. With a critically ill population, time is of the essence. In the previous trial (CD12), we believe that the 30% survival benefit (after 28 days) in the leronlimab arm versus placebo could have been much higher if IV administration had been used instead of SQ and if the treatment was with four dosages instead of only two.
Furthermore, in our CD12 study, the survival benefit in the critically ill population was 78% after the first-week post the first dose of leronlimab and 82% after the second week. The treatment with leronlimab was only for two doses (day 0 and day 7); from day 14 to 28, the survival rate declined from 82% to 30%, respectively in the absence of additional doses of leronlimab. In this trial (CD16), there will be four doses during the first four weeks of treatment, and with IV administration, we believe our chance of success is much improved. Furthermore, the primary endpoint in this study (CD16) is time to recovery. This similar endpoint in the previous study (CD12) showed the time to discharge from hospital to be 166% better than placebo in the critically ill population. This is why we are very excited to see the results of the interim analysis. We continue to be grateful to the ARO and BIOMM teams for their work in getting us to this point.”
They can't provide a link because they didn't fail a Long hauler trial. Never happened.
Why is that people are saying we had a failed LH trial but can't provide a simple link to support it. Please provide a link.
p value of .27
failed
That is your definition of a failed Long hauler trial?? Laughing...
Where is 3rd party validation of the LH trial?
Perhaps you misunderstood the question. You said there was a "failed Long haulers trial". When did we have a failed Long haulers trial??? Link please!
Same as failed HIV BLA, CD 10 and Long haulers trials.
When did we have a failed Long haulers trial??? Link please!
Same as failed HIV BLA, CD 10 and Long haulers trials.
It's not too late to get your 50% back. I expect we'll easily see it continue to climb next week following the 13D settlement announcement along with the news about the Brazilian critical trial starting. Should be a very good week next week and still a little time left (very little) to load back up before the train has completely left the station.
I’ve flipped this dog for more than 50% and only sold a few! Let it play out and see what happens next week.
When you said "head fake", I naturally assumed you were referring to the time when some dumped their shares the day before Nader announced the big Vyera deal. That was hilarious. I can't help but wonder if some didn't learn and sold again before this week's 50% increase in sp. Laughing...
I’m sitting back enjoying this head fake because the crash will be hysterical!
Already up over 10% again today. So glad I didn't flip and sell my shares yesterday.
I have a feeling the shorts won't be sleeping at all this weekend. lol
Shorts, continue sleeping well.
Yes, it speaks volumes. Nobody knows if they were invited or not, but clearly Nader and Kelly are heads down busy moving the ball forward while Patterson has too much time on his hands. Running a little test kit making company takes little effort or business experience.
Anyone find it odd that Nader or Kelly weren’t invited nor attended the Covid Summitt but Dr. Patterson was?
Hmmm, “everybody talking about Leronlimab” but no invite. That should tell a shareholder everything they need
Links are easy to post with homemade tables and values, but CYDY's financials don't support any of this. Everyone knows their monthly burn rate is less than $10m per month. If you have evidence other than your own guestimates, please feel free to share them.
So if it's not "challenged" it must be true? lol
Please show anything that supports the monthly burn rate is $20m and not $10m or less.
They had already sold $2m shares when they filed, so yes, $25m minus $2m equals $23m.
Actually, they want to raise 25m but only raised 2.2m
The only bankruptcy that needs to be considered at this time is for the shorts who can't see the writing on the walls and don't know enough to cover.
Cytodyn will not go bankrupt having a molecule as valuable as it is…..
The burn rate is less than $10m per month. If you have proof that it's $20m, feel free to share it.
They burn roughly $20 millions of cash out EVERY MONT
Sure, we'll sell $22m in shares and then claim bankruptcy. lol
I agree this will be very fun retrospectively once the bankruptcy news is official.
"Cytodyn is VERY PROBABLY" lol
No, cash burn is less than $10m per month. This is a well known fact. If they don't have shares to sell, then how did they just put up $22m of shares to sell?? lol
This was the underpinning of my bankruptcy prevision: a cash burn of $20 million a month (on average)
Looks like they just offered up another ~$22m in shares to new investors following yesterday's Emerging Growth seminar. I assume it will go fast and add enough funding to get us well past the annual shareholders conference. Big disappointment for those who were hoping for bankruptcy. lol
https://ir.stockpr.com/cytodyn/sec-filings-em...y_doc.html
Closed at $1.67 and up 23% today. Not too shabby for the start of the week.
Yeah, a mile high speed bump! The sp is tanking for a reason.
I think this is more of a speed bump than a brick wall.
I stand corrected. It's only down 56% and no longer 60%. Are you looking for more detail than that?
WOW - DOWN 60%! This is sinking faster than the Titanic!
The FDA's statement to HGEN says everything we need to know. In its letter, FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19. HGEN's treatment has known risks that the FDA doesn't like, unlike Leronlimab that has no SAEs.
Preparing to submit BTD for mTNBC
I wonder if Jeffrey will have swapped out the guitars with golf clubs this time, or if any of them will be wearing ties. It wouldn't surprise me to see Rosenbomb on a pool float with a Mai Tai. I'm pretty sure they'll include Ms. Yeager this time so they don't continue to come off as an ole boys club. And I'm fairly confident they'll replace some of Monday's missteps with a few new ones.
in between golf games and re-runs of The Golden Girls
Yeah, they should have said "very probably" listen only for the call. lol
This is a “listen only” webcast, which can be accessed via CytoDyn’s corporate website at www.cytodyn.com
"ALL Fife financings went bankrupt"?? Fife's loans went bankrupt?? Not sure how that's possible. Loans don't go bankrupt.
Game over?? LOL Yeah, that's definitely VERY probably official.
"CytoDyn is VERY probably"?? lol
This definitely looks official!
LOL - it's still NOT going to happen.
LOL - this is NOT going to happen.
LOL - OTC doesn't do trading halts except for under extreme conditions.
Because the market is what determines the sp, not the company. I'm looking at this morning's market and not yesterday's stale news. May be a good idea to cover at the opening bell before it goes much higher, but just my opinion.
If that is where the company values their stock, why do you think it won't trade there?
Now up 24% and their high for today was $1.71 in USD with high volume when compared to yesterday when at this time it was zero shares traded for the day. Something's up and I don't' think it's just general optimism.
Germany up 21%
And how were they debunked?
"The matters regarding Rosenbaum are merely allegations, recently DEBUNKED"