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It was dropped without prejudice which means they can take the case back up at any point. So no, NSF and Amarex are not off the hook necessarily.
Again..."they" did. Doesn't say it has to be their own cash from their piggybank does it? No, it doesn't. It says they will have to tender $6.5M which they did through a bonding company. The cash bond has been put up per the docket.
This is not how bonding works. If I want to get bailed out of jail I have to come up with X amount of money. I go to a bail bondsman and say "hey, I have to come up with (let's call it) $1,000 to get out of jail today" and the bondsman says "okay, you give me $100, I'll post your bond". Voila, the $1,000 that I have to tender to the court to get out has now been posted (the court doesn't care where this money comes from) which is what the court docket says as of yesterday. This is a very simple concept that happens literally everyday.
Put another way, if I go to the bail bondsman, pay the 10%, and he gives it to the court on my behalf, they don't care where the money came from, it's the same to them as if I paid it all myself.
Why would they need Argonaut in this case? They can just give the bond amount to the court directly.
Yes...the cash bond has been posted but bonding companies don't make you put up the full amount yourself. That's literally what they're there for. A bail bond company puts up the full amount of the cash bond for you to be release from jail and you pay a percentage of that amount that they keep as a fee once you show up to court and the bond is returned.
Argonaut (who allegedly does not exist) put up the $6.5M minus the 1-2% that CYDY had to put up. If the full amount is awarded to Amarex then CYDY will have to pay the full $6.5M plus the fee to the bonding company. If it is found that CYDY doesn't owe that money then the cash will go back to the bonding company and they will keep the 1-2% fee.
Can you prove that the court actually publishes the details/specifics of injuction bonds that you're looking for? If they don't then this is a moot point. The first website below shows that the $6.5M bond was posted. CYDY doesn't have to put $6.5M up in cash...that's not how bonds work, read the link from my last post.
Funny that you pick $10 just because that was a high based on speculation of the CD10 and CD12 trails. Before that though the CYDY share price was in the 30 cent range so it's still up from there by quite a bit.
Argonaut Insurance Company is shown on AM Best's website which is a company that gives ratings to insurance companies (these ratings are relied on by Fortune 1000 companies) and it has their domiciliary address listed as...Illinois. DEBUNKED. See second link below. It appears their parent company is Argo Group Holdings International, Ltd. based out of Bermuda. Doesn't really matter if they are registered anywhere or not though because the court said the bond is posted. Status of the company doesn't matter as long as they posted the bond...which they did.
https://www.pacermonitor.com/public/case/42127811/CytoDyn,_Inc_v_Amarex_Clinical_Research,_LLC_et_al
https://ratings.ambest.com/CompanyProfile.aspx?amb=2056&AltNum=2702056
An injunction bond is a type of surety bond. DEBUNKED
WHAT IS AN INJUNCTION BOND?
An injunction bond is a type of court surety bond. These bonds are used in court cases where one party (the plaintiff) wants to prevent another party (the defendant) from an action. The bond can pay for damages to the plaintiff caused by the defendant’s wrongful injunction. They are often called plaintiff’s bonds.
https://dblsuretybonds.com/bond-types/court-bonds/injunction-surety-bond/
Fair enough...I can appreciate that stance.
Do you believe him on how effective Leronlimab is too or just the things that agree with what you want to believe?
Wrong, the original poster that I was replying to pivoted to COV when I brought up the fact that they had shown efficacy in the HIV trial. You came in after the conversation started. Thank you for acknowledging though that they have shown that the drug is effective against HIV.
I'm sorry...are you saying that you think Covid is a bigger indication than cancer? Werid take but okay. How's that bankruptcy coming? Or the SEC investigation? LAUGHING
My guess would be because those indications are far bigger...correct? Correct?
Are you saying you think they aren't working on Covid as an indication because it isn't listed on the front page? If you click pipeline at the top you'll see what you're looking for.
I believe they have to submit the protocol first and then it has to be approved to be on the clinicaltrial.gov webpage. Like I said, I never said it had been approved just that the FDA gave them feedback that they could move forward with submitting it. I don't even know if it's been submitted.
It was...in HIV.
I have no idea. Did Nader say it because he's no longer with the company. Maybe that's why he got dropped.
Wow...what agency?
In CytoDyn’s recent discussions with the FDA regarding potential marketing approval of leronlimab for critically ill COVID-19 population, the agency stated.
Debunked. No Bankruptcy...says it all.
Yeah I'm sure the FDA would let CYDY post on their website a quote from the FDA that they didn't say. They would make them remove that in a heartbeat.
I don't know who made the statment against CYDY from the FDA either but I can acknowledge that it happened. Can you provide me with who made that statement or are you saying that's fake as well? It could have been from someone who got fired and or no longer works there so maybe that's not real either.
A statement doesn't have to be published in writing. They quoted the FDA and the FDA didn't make them redact it so yes...that's the statement from the FDA unless you can show me where the FDA said they didn't make that statement.
Zero efficacy is wrong. The fact that it didn't show statisical significance doesn't mean it showed 0 efficacy. Those aren't the same thing. At day 28 the critically ill population (which is the population the CD20 will look at) Leronlimab showed a 31% reduction in death compared to the standard of care. There were not enough patients and/or it was not enough of a reduction to show statisical significance but that still shows efficacy. It certainly shows efficacy if you compare it to days 7-21, while the drug was in the patient there was a very high reduction in death and as it wore off the benefit started to subside.
It's all here in a table for you.
https://www.cytodyn.com/newsroom/press-releases/detail/533/cytodyn-to-submit-newly-completed-topline-report-of-cd12
With this statement:
In CytoDyn’s recent discussions with the FDA regarding potential marketing approval of leronlimab for critically ill COVID-19 population, the agency stated: “While there are currently fewer U.S. patients hospitalized for COVID-19 daily in the U.S. compared to when you submitted your initial request for an expanded access protocol in August 2021, the CDC reports that 38,332 patients were hospitalized daily in the U.S. during the week of November 7th-13th, 2021. In this context, conducting a clinical trial in the U.S. that could support marketing approval of leronlimab for the treatment of critically ill patients with COVID-19 appears feasible.”
https://www.businesswire.com/news/home/20211209005635/en/CytoDyn-Submits-Protocol-with-the-FDA-for-Phase-3-Registrational-Trial-of-Leronlimab-for-Critically-Ill-COVID-19-Population
Before you go putting your spin, I never said the trial had been approved yet. I said they're letting them move forward which means submitting the protocol.
That may be but if it shows 0 efficacy then you don't move forward with a trial. If you're saying that the trial showed 0 efficacy then you're wrong and if you admit that it showed potential efficacy then it means the trial wasn't a failure. It didn't hit it's primary endpoint, sure, but the point of a trial if you don't hit your desired target is to learn from it so you can set up a next trial that will or realize that it never will. They aren't to the point where they can say it will never be effective for critical covid yet so nothing is failed.
It sounds like the opposite of what you said is what it sounds like. You said they failed ALL trials and did not qualify it with Covid trials only. The FDA is also allowing them to move forward with another, larger phase 3 covid trial for critical patients. If you fail, you're done, you don't move forward. All the FDA has said is give us more data that is more compelling because right now you don't have enough. They didn't say "yo this drug sucks, we're stopping your trial." That's a big difference and an important distinction. Take a look at all of the companies that did not move forward with Phase 3 trials in NASH after their Phase 2 trials. That is failure. Now, will the phase 3 work? Who knows but the data from CD12 is compelling so maybe. I don't think anyone would be acquiring this company based on Covid anyway...they'd be acquiring it for either NASH or Cancer and the data in those indications looks promising as well.
Companies acquire companies with debt all the time so it's very possible that would happen. I'm not saying it's going to, I have no idea what's going to happen.
They did not fail their Phase 3 for HIV. They're literally working on the BLA for it because they DID NOT FAIL it. Also, you don't go on to a Phase 2 trial if you failed Phase 1 so anytime they went on to a phase 2 trial it means they DID NOT FAIL their phase 1. Same with anytime they went on to phase 3.
Not getting the BTD on mTNBC doesn't mean they failed the trial, they can still move on to a phase 3 trial as the drug does in fact work on cancer. They will have to compete with the other drug that is currently the standard of care if they succeed in a phase 3 but if the pitch is "our drug works the same as their drug but we've shown no serious side effects" then I'm taking that drug to market despite the competition.
Over on one of the other boards someone said they reached out to Nader and he said he couldn't say anything for 3 weeks. If that's true, the PR came out on 1/25/22 so that would mean we won't hear anything until at least 2/15/22 which is Tuesday of next week. Who knows if that was true but if it is then we probably won't hear anything until at least next week or the week after.
So because Nader hired Amarex it's his fault they were negligent?
So let's get this straight...Carlos Slim, former richest man in the world, as well as other billionaires invested a ton of money in Theranos, therefore it's somehow his/their fault or they should have known that the company was committing fraud?
I hired a contractor to do a bathroom in my house. They did a great job. A year or so later I hired them to do another bathroom in my house and they did pretty shoddy work. I complained and they came back and fixed it. If they hadn't, I would have taken them to small claims court. Somehow it's my fault that they did a bad job after my experience with them said that they do good work?
Nader hired what appeared to be a reputable company, they did a terrible job, and he's taking them to court. That's how the real world works. Maybe Carlos Slim should have hired a consultant to make sure Theranos wasn't committing fraud or I should have hired a second contractor to watch over the first contractor I hired who had already done a good job for me previously.
Primary hit stat sig in both PPP and ITT. Secondary hit in PPP but not ITT.
Per Nader's Proactive Video today, 0.057 was the p value for the ITT secondary endpoint. Yeah, that's near stat sig. It was around 0.02 in the PPP which is stat sig on the secondary end point.
The question is, was it near significance in the ITT group or the PPP? Nader's statement at the bottom of the PR said that they did hit stat sig in the PPP which would mean that they were near stat sig in the ITT group which makes sense. The PPP group is a better representation of how the drug actually works.
The only thing to glean is that management is predictable? Right...let's ignore that they hit their primary endpoint. I love how everyone who posts negatively is focusing on the secondary endpoint. I don't care if they missed their secondary endpoint if they hit their primary endpoint which they said they did.
Stats should be given with 700mg data as that was the trial, a double blind placebo with one arm getting 700mg and the other getting placebo. Recknor added the OLE arm at 350mg but (my assumption is) because it wasn't actually part of the trial the stats don't matter to the FDA other than comparing for dosing justification. The FDA wouldn't accept them, they'd want to see the 700mg data. Is there a single study where the 350mg doseage has outperformed the 700mg doseage? If not then it should be expected that the 700mg will at least mirror the 350mg here and hit the primary endpoint and that's the one we'll see the data on.
That's a "they said they hit stat sig which means the p value is below 0.05". Unless you can find another example in a PR of them saying a p value over 0.05 is statistically significant then I don't need to know what the exact number is because it's below 0.05.
Umm...what about this press release do you think contradicts what I said? First of all, I said "I think" so it's possible that I'm wrong but not from this example. Secondly though, nothing on there had a p value above 0.05 which meets my comment "I don't think they've ever claimed in any of their trials to have a statistically significant result in a primary end point when the p value was above 0.05".
Also, anytime they were talking about a subset of data in the PR you provided they called out that they were looking at a subset which meets my other comment "They've also always called out if it was only in a subset of the population which they didn't do here".
What this PR does say though is that they hit a secondary endpoint with statistical significance.
I don't particularly care if they hit the secondary endpoint if they hit the primary. So because they didn't provide the data...does that mean they didn't hit the primary endpoint with statisical significance, yes or no?
Oh yes...if they stated what the p value is I'm sure you'd believe it.
No P or N value but they do say it was statistically significant which everyone knows means p < 0.05. I don't think they've ever claimed in any of their trials to have a statistically significant result in a primary end point when the p value was above 0.05. They've also always called out if it was only in a subset of the population which they didn't do here.
Not sure why you'd have to justify using the same placebo group for the 350 mg patients. Group A is getting a placebo, Group B is getting 700mg, and Group C is getting 350 mg. As long as the criteria were the same for people enrolling in the 350 mg group as the placebo group you should be able to say "look, the group over here that got no drug only improved this much, and the group over here that got the drug improved by more".
If you're going to get hung up on them using the placebo group here then it doesn't matter if they give a p value because the data isn't comparable so it's either one or the other.
The only real question is going to be "did the 700 mg group have better results than the 350 mg group or were they similar?" It's doubtful that they were worse but I will grant that it's possible. If yes then all of this is moot because that means they'll hit the primary endpoint of the trial with statistical significance and we'll move on to phase 3 with the potential of BTD.
"may" have. lol So no guaranty but definitely spend the money assuming the CRO isn't going to do their job. But that begs the question...do you have to get a 2nd consultant to make sure the first consultant does his job of making sure the CRO does their job?
No, you go to court like they're doing. Next you probably sue for damages, recoup money that you lost, and then go get the BLA submitted correctly on your own.
Can you imagine if Nader hired a QC firm or consultant and Amarex did nothing wrong? The spin would then be "Nader wasted shareholders money by getting a QO consultant to watch a perfectly capable CRO. lol
CYDY didn't pay the $15M because, against the MSA, Amarex didn't do what they were contracted to do. No one is even debating that Amarex didn't do the work they were contracted to do. They clearly didn't complete the BLA.
The $6.5M bond is only put up in the case that they lose or are found to have to partially pay Amarex based on arbitration. There is still the possibility that the arbitrator says they don't have to pay anything additional and the $6.5M bond is returned to them. Cydy was the ones who offered to put up the $6.5M in the first place though.
Okay...what would a consultant do if Amarex clearly isn't following the MSA and is lying? They would not allow an audit which CYDY had a right to per the MSA. They back dated documents according to the lawsuit. In order to sue for damages, you have to have damages so all a consultant could do is say "they're not allowing me to see what they're doing" which is shady but it's not proof of negligence.
And I hope Sidley backs up the truck for damages...
This is a ridiculous response. Can you explain to me what you think Nader was supposed to do to make Amarex do their job? Amarex, against the MSA, denied an audit which was well within Cytodyn's right to conduct (which is why it just got granted by the judge).
We've seen like 3 emails total...you have no idea if Amarex was telling Nader "oh yeah, we'll have it done by this date" which Nader relayed to the shareholders and that's why he pushed for them to submit on the date in question. There's a lot of context left out of the emails that Amarex conveniently submitted to the court. For example, how far along did they tell Nader that the BLA was? Did they make it seem like it was further along than the absolute piece of trash that they submitted?
Honestly, what do you think his option was other than to take them at their word? Maybe a lawsuit...like he just partially won? Maybe he knew how bad the BLA was but needed to submit it to have a case against Amarex for not doing their job. Seems to be working so far.