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KMPH completed a 1 for 18 reverse split and then raised 50 million dollars selling stock the same day.
That is a pretty big percentage of market cap.
At least CYDY CEO is attempting to get a market ( Covid ) before going this route.
NP also said there were 25 sites on the last CC.
Where did those extra sites come from ? CD12 supposedly had 18.
Yup ours shows it works, and though they had to dig out where it worked best, it did work, that will be proven out with the new trial.
The FDA does however, award approvals with less then stellar results and it does allow use for expanded indications that were not trialed and it does award approvals when things may bot be so certain and even then under accelerated conditions.
According to the FDA these BP trials were "FDA Accelerated Approval" and were approved by the FDA and yet the Phase 4, doesn't look so good.
Yes, a Phase 4 is a Confirmatory Trail after a drug has gone through the FDA accelerated approval process and been allowed to commercialize. It does look as though the FDA is still paying attention to results though.
"Six indications for immune checkpoint inhibitors (ICIs) granted under the FDA’s accelerated approval process that later failed confirmatory clinical trials are being reassessed as the agency continues an industry-wide evaluation of the pathway."
Uhhm, it also appears that when given the opportunity Leronlimab will blow the doors off these drugs in the TNBC.
Dilute us badly yes. But a new CEO building a war chest would also do what other experienced Biotech CEOs also do regularly.
Once they have diluted to the point where we are currently at , they Reverse Split to make the company look investable . They continue to dilute until one day they finally start earning revenue or get bought out.
I have seen this happen with every pre revenue and even some early revenue companies that I have followed in just the past year.
So, everybody who wants a guaranteed reverse split this year , raise your hands.
I think Dr Jacob Lalezari put it in these terms in his interview last summer.
In the early stages Covid is in its viral stage, that is when antivirals will work, however with most people. They are not aware that they have it yet.
But the time they are aware, it is usually too late for the antivirals.
Not really , it will be a different Phase 3.
What was learned on CD12 will allow tailoring the protocols in the new trial to show where this can really help and succeed.
Keep in mind, that the FDA did not slam the door on Leronlomab/CYDY. They left it open a crack .
They are not modifying the Trial.
This is a new trial with different protocols .
I think they called it CD16.
They said same sites as CD12. But I also heard them say 25 sites .
Priority Review is given by the FDA after the BLA is completed turned in and accepted by the FDA.
" Priority Review means that FDA aims to take action on an application within six months, compared to 10 months under standard review."
Sounds like you googled or got the answer to " After the BLA is submitted"
In order to make a bundle you had to have covered.
Why did you cover now if its going to .25 ?
Looks like you left a lot of meat on that bone.
25% percent isn't significant.
According to "facts" I have read in the last few days.
This stock could easily go 25% in the opposite direction on any given day.
I tweeted at CMS.
Medicare , AARP, someone had tweets about Joe Biden and his great Covid response so I jumped in there about his wonderful FDA throwing seniors under the bus.
Woodcock is tweeked and getting lots of emails.
Now if she was approached by the groups representing over 65 population about why they are being thrown under the bus would be good.
Who foots the bill for all that extra hospital care for patients 65 and over?
Medicare and Medicaid. If you want to get past the gate you need a lever.
What the numbers don't tell.
There is a hidden story here that everyone is missing.
What is the current quality of life of the SOC patients vs the LL treated patients ?
18 Hospitals in the trial. The latest PR states and/or Maybe more.
They now have data in hand to say, you have a good opportunity at recovery and less time in the hospital.
It always takes longer. 1 month fastest to 2 months. Is my guess.
Yup, who pays for those extra days in the ICU ?
That is the pressure point.
Yes cheaper drugs.
Medical Cost = Drugs + Hospital Costs per day.
You tell me, what was accomplished in the past ?
Sorry, but Big pharma is not likely to give you what you think your shares are worth.
They would use current non FDA approval to low ball a buyout price.
Heck, you could probably sell your shares tomorrow for more than a Pharma will offer.
Leronlimab has promise but it is not a Blockbuster yet. You don't get Blockbuster prices for potential .
I did not mean to insinuate that you do not have a right to voice your opinion.
I have never told any of the shorts that they don't.
An investor does not have to do anything other than their own strategy whatever that may be.
My opinion is that he should sell all existing Leronlomab to a different country or countries. If they want to buy it, sell it.
He has results in hand. For the US FDA and the Phase 3 with it's endpoints set in March/ April 2020. P value not met.
However, they will have data based on the subgroups that show where LL helps. Some countries may just have their people's well being in mind.
That is what the CEO should do, to ensure the success of this company.
He claims he got the results Friday let's give him a little time to see what he does with them.
You can always hedge your position by shorting .
I am in this for hundreds of thousands of dollars also.
Well, every other company in the world doesn't have him as it's CEO.
Seems like there are many choices .
I will ask this question, where was Cytodyn when another person was the CEO ?
Courting for funding ?
People exchange money for ownership in this world. Nobody gives away money for nothing.
Big investors get big ownership.
It sounds like you believe Cytodyn will fail, that's a pretty good reason to sell, if you own stock.
It is also a reason not to buy stock if you don't own it.
You are correct, the quickest path currently is to get the 140 done with the new easier to meet protocol and ensure EUA.
That gets the ball rolling in Leronlimab usage.
Getting the BLA submitted with corrections and complete data as the FDA has requested, still puts BLA acceptance into Q3. PDUFA into Q4 or 2022 Q1.
You can hurry up and submit a BLA but that just gets you more delays. Take the time submit the BLA and then hurry up and wait..and wait..and wait.
NP is multitasking trying to get to a point where Cytodyn can survive without selling stock. The only way to do that is to take the shortest path to sales.
The shorts aren't scared, they are opportunistic.
They will spin the legend of the failed trial. They will pile on Monday morning and on many mornings after this. They will bring the price down and scare many weak hands into selling.
The supposed longs who have it in for the CEO will help them in this.
My hope and my bet here, is that one morning we will see a sale of Leronlimab to a country that is not the USA. That Cytodyn is in the black.
Whether people admit it or not, there are special interests that want to see Cytodyn fail.
For those interests it is a waiting game, which is why Cytodyn needs to sell into markets that don't tie in anywhere with them, make money, pay debts, have hundreds of thousands of doses out there showing it works.
Thank You also misiu143 !
I appreciate all your posts, and to see a doctors perspective is always encouraging.
It takes time to do things right. Cytodyn is moving forward and adding layers of Covid19 knowlegde an showing it works each time.
Each time zeroing in on a tighter target to acceptance.
Blame the FDA.
You say it is NP's fault top to bottom that there is no EUA.
Okay, so what is your thesis on this ?
Right,
NP is quiet and everybody cries.
NP speaks and everybody cries.
I take this to mean people are crying because NP didn't make them rich in 2020.
I prefer to know what is going on.
I agree with you.
Covid is not over.
There are way too many cracks where Covid can spread, antivaxers, mask haters, timelapse between immunities, lack of antibody testing or a comprehensive antibody testing strategy anywhere in the US and in other parts of the world.
Covid testing is down immensely, thus reported Covid cases are way down, nobody speaks to that little fun fact. However, vaccinated people are losing the fear of Severe and Critical Covid as they have been conditioned perhaps rightly so, that the vaccines prevent that.
But then all you have to do is look at the number of un-vaccinated population and state governments thinking they have an all clear to open, for another wave to happen.
I watched the Youtube last night, I think NP has the urgency and recognizes that Cytodyn needs to sell some LL to be able to deal from a position of strength in the future.
Yes and that would still be a gamble as the SOC can keep people alive and that is reason for the endpoint failure, not the ineffectiveness of Leronlimab, but the effectiveness of the SOC in keeping people alive. The way this trial was designed a husk on a ventilator and life support has the same scoring weight as a patient walking out of the hospital. While one is living and getting on with life, the other is just technically alive. Huge differnce, same score.
The FDA will allow Cytodyn the new protocol which they require a larger population for, but with an endpoint that Leronlimab has already beaten with a smaller population.
This company is in a very different position than it was a week ago.
While the Trial was not enough for the FDA to grant EUA if they stick to the guidelines. The trial showed effectiveness, it showed it works.
The FDA did not slam the door, they left it open a crack with allowing them a new protocol with an achievable number and a very achievable endpoint.
They also have data that they can use to market Leronlimab in other Countries who clearly have need.
There is no valid comparison between now and the past, they now have Phase III data in hand.
I have another Bio-Tech stock that took a year to complete the CMC module for their drug candidate. They submitted a rolling BLA and completed the BLA in Dec 2020, a PDUFA date in August. Unfortunately these things take time.
Yes, and he also said after that , that he was holding initial stock for the US.
The trial is not a "test" that he failed. It was a drug trial that was constructed with set parameters. They kept it simple.
Alive or dead.
The SOC improved, it started keeping more people alive.
They have been given a chance at a protocol that should be easy to reach. The hardest part will be getting the patients.
The advantage is that now, when speaking with potential trial participants they have solid data with which to make claims
His comments did not say no dilution , he was speaking to the point that possible financiers were ready to hand over modest money in return for Massive amounts of shares .
Nader held back from selling to other Countries because he did not want to come up empty for the US and the hospitals that supported the trials.
I do believe he has learned his lesson and will shop the treatment to other Nations.
He has also been given a chance at a protocol that should be easier to make. However, it will take time, I am sure the FDA hopes that this closed the door on Leronlomab.
The BP lickspittles at the FDA appear to believe much like the ignorant populace that COVID is over. My opinion is that Texas and other states that follows it's model will explode with the variants.
My opinion is that while he jumps through another FDA hoop, he sell all the existing LL and get Cytodyn in a stronger position . If the US wants some, they can ask nice and get some from Batch #3 and wait while it gets manufactured.
I agree that the Piecemeal release is frustrating.
The trial itself took a while and was recruiting in the 1st wave when SOC was more marginal. It was recruiting in the lull between waves and it recruited the last half on the Fall / Winter Covid explosion.
The when as well as the where all have an effect on SOC mortality as well as SOC plus LL. So unfortunately until they release actual #s we won't get a clear picture.
What if the only patients to progress from Severe to Critical were the SOC? After all we have 500,000 examples of this happening.
From the EINDs and from CD10 how many treated with Leronlimab went to the edge of the cliff and died ? Not many and the EINDs started almost right at the edge.
WE are seeing deaths still, even though the hospital rates have dropped off, and this is with the standard of care.
Reducing that by any number should be acceptable, especially with a low to no risk of side effects.
If you cause no harm and effect no improvement is one thing.
If you cause no harm and effect a significant improvement is an entirely different thing.
The Insurance companies will care a whole about the 6 days less in the Critical Care unit.