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Time to jump back in here....
2021 will be a new phase for longs that have been dedicated to the company/tech
Remind me again what we are anticipating from them? Would they announce an approval before unblinding and FDA making their position known??
Good volume and movement here. Been a looong hold but maybe it’ll pay off.
It sure is...in 30 days this will be closing in on a massive cash injection as we hit $3.44 warrant strike. Glorious days ahead.
Agree with the sentiment. I still am long on the prospects of the company...the technology is essential and commercial applications are huge. However, it’s dead money right now and there are too many opportunities out there. The company needs to generate real news and real investor interest
Everyday I want to buy more...and keep watching it go up.
Guess I’m fortunate with what I accumulated months ago..
So the 91 weeks wouldn’t need to be obtained before phase 3 initiated? I’d imagine the phase 2 will fill quickly
Absolutely. The duration is completely necessary but it sure slows down moving to/through phase 3. Lots of people impacted along the way..
91 week study duration. Dang....
I pray this is an inaccurate assessment of the process undertaken to get these vaccines to the general public and the risks associated (detailed in this publication) do not manifest.
With that being said, the fact we have zero RNA virus vaccines should tell people something. Historically they have been either unsafe or ineffective. And now, without any animal studies or long term human observation studies, we are vaccinating the masses. It’s still unclear to me how long immunity is maintained and what the effectiveness is with the genetic variants of Covid that have been reported on. This could be an epic disaster...or not. Time will tell if the “cure” is worse than the disease.
Why are people so down on a potential financing? I’m not saying the run is a lead up to that or it isn’t, but additional financing to pay for the next acquisition (Q1 2021) is perfectly fine IMO. Growth is good...continue to buildout for the eventual buyout.
I miss the days when it was you and scumbag bantering...at least there was information being exchanged that was informative about what the company was doing.
I’m high on the tech. It’s a multi multi billion dollar industry that requires safety enhancements to bring it to commercialization. This company may be one of the answers...who knows??
That’s a good question, I’m not sure how that works with a move to the big board.
My biggest concern is buying again now or expecting a coordinated attack before the uplist occurs?? I anticipate this will move to Nasdaq before EUA granted
$4 bid at time of listing.
Recent influx of traders would be a good start...
Couple quick questions and a statement...
1. If the primary endpoint is met at the end of this final evaluation period, is there anyway the FDA approval could be denied?
2. Could the FDA evaluate the data before the end of the 28 day evaluation period is complete and approve with the existing data now that the study is filled?
If/when approval happens, I sure wish we’d be sitting on one of the big boards...institutional money would launch this thing
No other therapeutic option has even come close. This one has completed its study enrollment and is on the verge of meeting its primary endpoint (mortality!) and already boasts an impressive safety profile. All this plus the clinical indication is for relief during a worldwide pandemic.
If the unblinded data proves statistically significant results, there is zero percent chance this isn’t approved by end of Q1. IMO
Thanks. I guess it would be nice to have a definitive date to project the final endpoint analysis. I suspect we don’t see approval in another country prior to the FDAs decision on it. Being this close and contracting with another country to receive a limited stock pile of drug wouldn’t sit well.
Is CD12 completed enrollment a PR worthy event? I don’t really care either way honestly I’m just curious how something of that nature is handled press wise
Think about where this company is right now. They’ve completed phase 3 enrollment with mortality as the primary outcome! For a therapeutic that would be first in class for a worldwide pandemic....
If this isn’t the most undervalued biotech out there I’ll eat my socks. I cannot believe that this is headline news for the next 30 days. Cytodyn needs to focus on major media markets for the next couple weeks as this could easily be 10x the pps it is now in short order. Think about what they are on the verge of reporting and offering in the fight against Covid
Thank you so much. I mentioned the compassionate use angle to him and his wife. Hopefully he qualifies for something. Appreciate the response CTMedic.
Have a close friend with non-operable refractory glioblastoma. Thought it would be worth a shot to have him reach out to Dr Lalezari. Couldn’t find a direct email but I know others have posted it previously. Would someone be willing to share that address again please??
Fundamentals are a bitch to argue against...
An OTC biotech on the verge of FDA approval of a novel therapeutic for a world wide pandemic...um, I think I’ll hold for the next 60 days just to see what happens.
And this indication isn’t/wasn’t even the most likely indication 12 months ago. I’m here for the HIV and various autoimmune indications. If people aren’t accumulating right now, that’s on them.
Is this significant in some way?
This is turning into dead money as other securities make record gains. My need to cut bait and reevaluate next quarter
This. Thank you...
I’m not trying to be negative here, believe me. I’be been accumulating here as the technology is interesting and will certainly have applications to result in expanding market share. Most OTCs are horribly mismanaged and attempts to uplist prematurely would be devastating. Maybe there’s something to warrant that level of talk though...??
I’m fully aware of what the ultimate objective would be and the advantages of getting off the OTC
However, this company is a looong way from having a product or service that institutional investors would look at and feel comfortable putting money into. Additionally, a reverse split that isn’t appropriately timed with the uplist would result in a declining pps that would prohibit uplist in the first place. Unless a company supports a reverse split with substantial growth or partnerships signaling growth, the reverse split would be a gross miscalculation
Why would they do that? They don’t meet criteria for uplist and there’s no other advantage to do so.....at least none that positively impacts shareholders
Financials reported this week?
This is really important to understand as a viable treatment option for so many autoimmune related disorders and others that aren’t but the mechanism is immune/inflammatory cascade related. The key to many of these is early intervention.
I think Leronlimab will become a standard of care in a number of diseases as part of early treatment algorithms
Good post...appreciate the clarity on pros/cons. It seems management is comfortable with their current course. Funding is an issue...we’ll see
If they say to continue as is and keep enrolling patients to meet the primary endpoint, that’s a good thing. It means they are on track for statistically significant data and approval.
If they opt to unblind and take a penalty, if the data shows that they are not on track for a statistically significant endpoint, essentially the study is terminated. There’s no upside to doing especially if the recommendation is to enroll 60 some additional patients.
If they request to see the data and it looks good, they FDA is still going to recommend continuation but now the penalty for unblinding makes it more challenging to hit the primary endpoint. I’m just not sure what the advantage would be to asking to see interim data unless you want a reason to terminate early due to funding concerns or some other motivation to terminate the study.
I probably did a poor job explaining but it’s how I interpret what he said and the strategy around the decision
Anyone care to discuss the difference between here and NEXCF? I’m curious about the tech differences and the target applications. I’m surprised in the difference in pps movement between the 2 over the past 3-6 months, however, revenue generation is clearly a factor.
From a long term investment perspective, is there a preferred stock or do they both offer solid opportunities in a rapidly expanding market?
2018 was a company built on a theory. It’s taken years to get it to this point and it’s just the tip of the iceberg. My fault for not taking gains more aggressively during that stretch. Live and learn....
My position is 10x what it was in 2018...I’ll be ok
Soooo....buy more?
Oh, don’t worry
It still boggles my mind the way Remdesivir was handled. The fact that no other therapeutic is near completion of phase 3 studies, and with an established safety profile, I find it almost impossible that leronlimab isn’t approved. Even if FDA doesn’t, the resurgence of cases around the world will prompt some country to approve and have available for use. The next week will be interesting to watch science/politics/pandemic all factor in.
Nope. News is what moves OTC stocks run by shorts. Revs are needed here to move the needle and give institutional investors some confidence that the tech is being adopted.
There is no more difficult patient population to conduct studies on. Period. It’s why new therapies for severe sepsis and similar clinical settings have been lacking. Improving the survival rate on a critically ill patient is a monumental task, and typically the enrollment numbers are massive just to power them correctly. I am eager to see these interim results. I expect the trial will need to continue to its endpoint before the FDA decides the fate of leronlimab for this indication. However, if it shows clinical or statistical significance in this critically ill population, we are sitting on an absolute gold mine.
That was a really solid interview. CEO is confident, enthusiastic, and extremely articulate in what’s happening with the company. I’m rarely a fan of OTC level CEOs getting out there like this but he definitely did the company well by doing so.
This is pretty significant news. Becoming the leader in this massively expanding sector...this company will be a monster in years to come. Or be bought out at a healthy price for its coveted technology rights