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My thoughts exactly Blueheel. I'm frustrated by the reset on the HIV BLA, but the P3 trial was so convincing (3 yrs ago). I believe CD12 will get the EUA in the next 30 days or so, and if we miss, I'll just have to grin and bear it for another year. It's not like I would look to exit at $2 with HIV still out there. I'm in another that won't sniff sales until 2025.
NASDAQ isn't happening before CD12 analysis. It never was despite some continuously saying it would and even trying to pin specific dates on it. We don't meet the criteria, and further, why would NASDAQ list us today when they know the price will plummet if CD12 doesn't get us approvals? They know the release of the data is imminent, so just wait it out if we gain approval, we'll meet the requirements and we'll be a hot name for the exchange. Pretty simple.
Landstreet video...between two boards, I've seen this 6 month old take posted five times. If you watch it, it's clear that he is talking about last summer's events in real time, even if you ignore the fact that he is standing around outside in short sleeves. "Guarantee we won't see a vaccine this year"
Definition of insanity: Having the same call over and over and expecting a different reaction from the market.
There was no reason for this call today. Zero. We'll have the data soon enough, and I guess that's about all I can say on a positive note.
We need to unblind ASAP. I have changed my position about going to 390 after Moderna crushed it. Out of 15,000 that got their vaccine, 11 got COVID (vs 184 placebo) and nobody progressed to severe. If the FDA allows, they can have 20M vaccines this month.
Now there's no telling how many will refuse to vaccinate- we still have folks out there who won't get polio and measles vaccines, but with the other vaccines and the ramp up in production, there is a good shot COVID is waning by end of Q1. All of that is great for the world, but it really places a sense of urgency behind CYDY trying to find a spot in the market.
Agree 3x. I wish they would have been more aggressive from the start, and certainly moreso at the 195 interim. Water under the bridge now and time to finish something, anything.
Last time we were looking for an endpoint at 28 days and it took almost 3 weeks on top of that. Now it's 42 days, so you're looking at +/- 60 days from 293 to hear from the DSMC.
Fair- poorly worded on my part.
Faith that the great science will overcome poor execution of a business model is naive/blind.
Blind faith in amazing science is still blind.
You keep missing the point despite your obvious and advanced grasp of the science. The point is right now WE don't treat S/C either in the marketplace. Just like we don't treat HIV. We don't treat Cancer/Nash/ etc. At very best, we might have COVID EUA in 5 months. We not only don't have money to get us that far, we have other liabilities to be covered and will be forced to borrow/dilute on unfavorable terms.
For the BUSINESS of Cytodyn, executing a plan that allows you to sell your product is what matters, and there are mounting failures to do just that.
Buck- seventy. Breathtaking crash I just didn't think I'd see. I'm happy I didn't exercise my warrants.
Yep. Nothing to say that isn't just a desperate cry for attention.
The idea of having a large impact in COVID ended yesterday. By the time we are able to read results (interim) and submit for any sort of approval, two Pharma giants effectively have the market cornered. I do hope we can get approval and save some lives, but I strongly suspect there will be more therapies approved, and vaccines are likewise progressing. This is obvious folks. The longhauler trial- if it ever happens- is just a grasp at straws. Time to go back to where we still have a chance, HIV, Cancer, perhaps NASH.
Nader is listed as a contributor, so maybe, just maybe, cooler heads have prevailed and they realize that together they are both better than the sum of the individuals.
He's in a tough spot. There is really nothing he can say or do that won't ring hollow to the rational investors. On the other hand, if he doesn't pull some rabbit out of a hat somewhere, we are well on the way to bleeding to pre-COVID levels. I don't really have a clever suggestion at this point.
Pfizer vaccine doesn't remove the need for therapeutics, especially for the first half of 21. However, if it (or other vaccine) works, it will reduce the long term demand. We need LL yesterday, but we won't have a shot until March or so. That's just the math on getting results- which will still be interim- for our CD12. From a business revenue perspective, we are potentially cut the market significantly, and don't forget that there are other therapeutics who will likely beat us to approval, so that pie gets sliced again. We can help, but it's not going to be a blockbuster it could have been if available today.
43,000 already took the vaccine and the DSMC didn't stop for safety. I'd take the shot without another thought. Of course we have measles outbreaks in the anti-vax communities here in 2020.
Let's be honest, Leronlimab for COVID is a 2021 event.
Study enrolled 43,538 participants...94 cases. That's telling you almost all cases were in the placebo group.
I get tired of shortsighted bravado like those wishing for (claiming) lower prices so they can "buy on the dip". For one, I think it's largely hot air, but very importantly, we are on the verge of having to raise capital. This is 90% going to happen before the end of the year. It is much better to control dilution if we can accomplish a raise at $3+ dollars than at $1.00, so if you really believe in the company and want to see it succeed for all of us, make the buy and quit acting like you're a master of timing the market.
Agree Saltz. This dance is tiresome.
This sounds like the guy who had an inside source who claimed we would be uplisted on September 23. In other words, I don't believe you. Not saying you made it up, but somebody almost certainly did.
One of these days, hopefully, I'll be wrong.
IMO, the long haulers trial is a complete waste of time right now, but much like the other 12 trials we were going to do in the second half of the year, it will never get off the ground. CD12 will likely prove out and get approval at some point, but it may be too late to be at the top of the therapy stack.
Otherwise, it's back to HIV 2H 2021.
That's not trial data, it's a repackaging of the compassionate use anecdotes that we knew about in April/May.
The “unconquerable, invincible, unbeatable Cigar (Leronlimab)”
Dr. J is always good at bringing me off the ledge.
If he is perplexed, he really is in over his head.
What's to describe? Despite claiming to adding multiple sites and countries, we clearly slowed as soon as we hit 195. Whether intentional or not, the numbers don't lie.
35 enrolled in 60 days = stalling
The paranoia around shorts is off the charts on Cytodyn boards. There are a few trolls for sure, but most are just a frustrated longs with a growing sense of doubt due to the management failures, delays, and the continued stalling of trials.
With POTUS getting Regeneron, they'll get all of the MAB trial enrollment. We'll be well into 2021 filling the 395, so I agree. Of course, we have to read the hints given to us before going that route. We don't have full access to unblinded data, but I think we should have enough to make an informed opinion if the drug is truly having a major effect on patients.
Was it the data for the 535 mg and 700mg? or was it the syringe manufacturer? or was it the occupancy test that our now estranged former partner Dr. Patterson screwed up?
PE for P3 on HIV combo was hit in the spring of 2018. We are now in Q4 of 2020 and it's 50/50 we will have an application submitted before the 3 year anniversary while continually being pumped as "any day now", "next month", "next quarter", "end of year".
The problem with going to other countries and bypassing the FDA isn't necessarily the concept, it's the execution. If we actually did it, that would be nice, although not the preferred route. However, we keep coming up with new countries that we tout as being interested in approving Leronlimab and nobody is actually doing it. Remember Mexico, UK, Israel, Brazil, et al. This is a distraction from the fact that our own FDA won't accept a half- azzed application, so we go throw a tantrum and see if we can slide it by elsewhere.
It was quite obvious that REGN (among others) were going to beat us to the line before CD10 was given another chance to fill P3. I suspect their cocktail has a lot of side effects, so the story isn't over, but we have to have success NOW in CD12, or we're just beaten here. The REGN stuff will likely work to a degree, and they'll be selling boatloads of it very very soon.
February 19, 2018...damn near 3 years ago I read this headline.
CytoDyn Inc. (OTC.QB:CYDY) reports the successful achievement of the primary endpoint in its CD02 Phase 2b/3 pivotal clinical trial with PRO 140 in combination with existing antiretroviral therapy (ART) in patients failing their current HIV therapy.
Now I know the FDA isn't easy, and I know it takes a mountain of data which is especially difficult for a small underfunded firm to submit correctly, but we are 30 months from hitting the P/E and we don't have the fracking BLA submitted and are only guessing it will be End of Year. THEY ARE FAILING stockholders and more importantly, patients who have multi-drug resistance. FINISH SOMETHING.
The only thing on this list that can keep us above $2.00 for the next 6 months is the interim CD12. I've seen enough of these discussions with Big Pharma and other countries to know they will land nowhere. I've been hearing Big Pharma buyout for the almost 3 years I've been here, and it was all a big fat nothing. Other countries aren't going to give us a serious look if we can't convince our own FDA to approve, so all that meeting/discussion does is line us up to apply for a license in the UK if we get our BLA approved in the US sometime mid-late 2021. Based on experience, when you see a slide that says EOY, you should hedge your bets. At best it's December..it just is.
NASDAQ is now DOA, especially with the price below $3.
CD12 full trial enrollment will put us behind one of the big boys, and even if we have a marginally better therapy, somebody else is going to have something approved and selling it by the truckloads. No way we have CD12 data in 90 days- zero chance. That would mean we enroll another 170 in 60 days = +/- 3 per day. Getting it fully enrolled by EOY is bordering on unlikely.
I really hate to be this pessimistic. Maybe CD12 interim data will shock the world.
Executive Comp plan passes..inside THEFT
This is seriously 6 months old- just stop. I remember the PR, which was exciting at the time. It's all water under the bridge and does ZERO to help us. Nothing new and nothing that changes anything about our chances of moving forward with anything they are working on.
Right on Scooter...the NASDAQ red herring is going to go away in a few days. Nader will frame it as Cytodyn turning them down because there were conditions, and you know ol Nader is always protecting shareholders from dilution. That is, of course, except when the dilution lines his pockets with shares.
I still hold a lot of hope in CD12 because of Dr J, Dr. Paterson, and some of the anecdotal cases from EIND that showed it works. To take a drug that works in the middle of a pandemic and not get it to the finish line is a crime against shareholders, among others. There are a lot here who want to put on the tin foil hat and blame the FDA/Mexico/ other worldwide health agencies, but for owners of a company we have to count on leadership to get us there, and the buck stops at the top.
To Nader's everlasting credit, he is the primary reason that Leronlimab is on the cusp of helping people who desperately need this drug. However, he doesn't have the skills, knowledge, connections or understanding of the regulatory approval process to push this over the line. Further, it is easy to deduce that instead of putting the right people around him, he terminates relationships that could help.
Give me a break. We have been "in talks" with 5 pharmaceutical companies for at least the last 3 years per management, yet we have deals signed with Vyera and American Regent instead of a big boy. Management is anything but reliable on this topic.
Exactly BL...if we had an approved drug, the COVID play would be exponentially stronger right now. As it is, we are trying to get Emergency Use, which by definition is a Hail Mary of sorts. If we don't impact COVID, that gaffe/failure will haunt us for quite some time, not to mention the potential life saving impacts we could have made.
Saltz- that's been my argument as well,and I've been on record as saying we'll never even go to P3 for m/m or conduct a long hauler trial because we simply don't have the time and resources in an ultra competitive landscape.
I'm quite positive based on EIND that we will show efficacy, but I'm terrified it won't be enough to halt the trial. If we're enrolling 1 per day, we'll be into 2021, and there will quite likely be others who establish themselves, even if they don't work as well. That's where I see a disconnect with the science and the business risk. We need that money to move the rest of the company forward.
I jabbed at him for posting that...nothing personal to him because the rest of his posts were fine, but there have been ridiculous claims like that all along and I get sick of those that do nothing good. The claim was "a pharma contact"...gimme a freaking break. No way a random message board poster has a pharma contact with insider info to put on IHUB.
I think people just want success so badly that they imagine things to the point of starting unfounded rumors.