New Investor as of July 2013, but small biotech Investor.
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We all know that we don’t actually need “approval” for NASH for the company or stock to “succeed”. The 700mg NASH data could very well be the beginning of big momentum for the company.
The potential for Nash results and potential partnerships is huge. NASH is a Behemoth indication.
Good news is good news regardless of the share price. The goal is approval, not PRs.
Nice rise in sp. hopefully we get new this week! We are due soon!
Lol! We are at $10 on nothing. Now $17 with Nash data?
I have oceanfront property in Oklahoma for sale!
He’s obviously good enough to attract the attention of big Pharma individuals joining the team.
Webcast from yesterday.
“With an Impact Factor of 6.429, Frontiers in Immunology is the 5th most cited Immunology journal in the world.”
I believe it was granted through something similar as right to try, but I’m not 100% about that.
Posted by Spencer on YMB
“Soooo. For all you ***********, *** people and ****** **** that are on this **** here is the real story of the Canadian Cancer Patient. She has been taking Leronlimab since September 2020. She started on Leronlimab as part of a trial and when the trial ended she and her oncologist had to apply for the Canadian Special Access Program to stay on Leronlimab. If she was in the US the application would have been under Right to Try. The approval for the SAP was granted one month ago. She has been on Leronlimab for 14 months and she has been No Evidence of Disease - NED for exactly one year now. This is the first time Leronlimab has received this type of approval in Canada. This does potentially open the door for other cancer patients to apply under the same legislation as the first approval is definitely the hardest. It took Health Canada 6 weeks to make the decision. I know these are the facts because I know her personally.”
Again, totally overlooking the clear and explicit [for manufacturing] that anyone would see.
Actually, it’s blatantly dishonest.
That’s because the full transcript reveals they were only speaking g about the manufacturing portion of the RTF, which is conveniently and disingenuously ignored. The transcript goes on to talk about the clinical aspect after they specifically talk about the manufacturing issue. Nothing to see here.
We’ve heard these insinuations time and again. Unsubstantiated claims of legal woes that amounted to nothing. BTD submitted! Tick Tock!
BTD submitted. Tick, Tock. Tick, Tock! 60 days maximum for a response from the FDA!
Brazil about to put the smack down on doubters with data. Just biding my time.
“Consequently I would advise investors to be VERY careful with stories and opinions.
And focus on facts on only facts about Cytodyn.”
We hit $10 on zero news really. And why did it tank? Because of a short attack letter that was later retracted. Last time I checked, Nader wasn’t much responsible for the drive up, but he certainly wasn’t responsible for the letter or the sp fall that followed.
I’m not here for a $10 sp. I’m here for the approval of a phenomenal drug. That alone will bring its own rewards, both humanitarian as well as monetary.
I’m no legal expert, but it does appear that the 13D will award themselves 3 Million dollars of the company’s money without a vote of shareholders if they ‘win’. Page 17, paragraph 2.
https://d1io3yog0oux5.cloudfront.net/sec/0001104659-21-104441/0001104659-21-104441.pdf?fbclid=IwAR34J85XlmCv4du6jl3mLaZ7rdtrq0kR707FFEKY1vdpIde7Zc5c3dKhbpQ
Other legal expenses I cannot speak of. I am no law expert, and I’m sure that Cytodyn would have to seek that reimbursement when the time comes. Whether they can or can’t, do or don’t is more a matter of time, and a matter out of my realm of knowledge.
All in my opinion of course.
From Another source:
Aaron:
CYDY SUING 13D POINTS PT 2:
1) We now have the answers from 13D. As I stated in my last post about the chancery court case, the accusations by Cytodyn against 13D were of a binary yes or no nature.
I will go through some later but basically 1) Are the facts stated by Cytodyn true? 2). Did 13D leave them out of their submission to investors?
The answer is yes and yes. There was no way for 13D counsel to deny it. This has left them with the only possible avenue to explore. While everything asserted is correct, it's not important or out of the hands of Patterson whose company made the decision without him (more on that later).
Many posters have noted these are horrible answers but under the circumstances it was all they had.
2) CASE WAS EXPEDITED.
Generally a case like this gets expedited because the judge has seen the preliminary evidence and believes that the decision is a forgone conclusion. If so, best to not waste the courts time and make a ruling.
Had the 13D response been to refute the facts that may have swayed the judge. But saying the facts are true but insubstantial I don't believe will cut well with this judge
This judge apparently has decades of experience in corporate law decisions and corporate bylaws. She saw something (the binary conclusion I mentioned before) that caused her to expedite the case.
The 13D response is basically, your eyes aren't deceiving you, it's your brain. None of those material facts are important!
I don't think that's going to hold much water.
3) NEXT STEP?
Most likely the next step is the judge is going to now throw the ball back to Sidley for a response/rebuttal to 13D's answer and she will make a judgement from that.
4) PATTERSON TALKS TOO MUCH
For all BP scientific knowledge he doesn't seem to know what most every American citizen knows. When involved in court proceedings, just shut up.
The argument that BP wasn't part of a buyout offer for Incelldx is practically refuted by BP's own tweet. He discusses it openly even mentioning a confidentiality that was broken so he can talk about it implying he was directly a party to the actions (This tweet was only last week SMH).
Cytodyn is suing for an injunction to silence the 13D and there is Patterson saying he is free to openly discuss matters now. He's practically making the case for Cytodyn that he needs to be muzzled.
But wait there is a lot more.
5) DID BP GET PAID FOR ASSAYS?
BP tweeted that he withheld the Assays because he didn't get paid. (I will link to it separately in the reply section so it doesn't pull this main post down).
It's been stated as fact in the Sidley documents submitted to court that BP was eventually getting $20,000 per month for his services. It seems BP felt the Assays were a separate deal
One can surmise where this went off the rails. BP demanding payment for Assays, NP asking what the hell he is paying $20K a month for?
So were the assays supposed to be separately billable?
The Assays would have been months of work. If BP felt he wasn't paid for months of work, one wonders why he didn't sue in court for non-payment of contracted work?
Ask yourself if you would have sued the company after performing months of labor and didn't get paid?
NP certainly has evidence of the monthly$20K arrangements. It looks more and more like BP simply withheld the Assays.
6) BP TIMELINE
A) BP getting paid $20K a month from Cytodyn
?? BP hyped Leronlimab even doing speaking engagements
C) BP tries to sell Incelldx for $350 million to Cytodyn and is rejected.
D) BP gets caught trying to patent Cytodyn tech.
E) BP withholds important Assays that will affect BLA submission.
F) BP doesn't sue for non-payment of Assays work even though he claims he is owed money
G) BP starts playing up Ivermectin and Maraviroc and downplaying Cytodyn.
H) BP signs onboard to 13D proxy battle.
I) BP involvement from the timeline above left out of 13D submission
Now how does this timeline look?
7) BP SP AFFECT
The OWS comments by BP may also be submitted in the Sidley response.
They caused a positive spike in the stock price as well as generating a number of articles. The info was incorrect as well but that's besides the point.
The point will be to show how the stock price jumped just on the single comments of BP.
Why is this pertinent? Cytodyn is claiming the 13D and BP need an injunction because they are affecting the SP. BP's OWS comments and the resultant SP spike go towards proof his words matter and the need for the injunction.
CONCLUSION:. None of this looks good for 13D. As this is simply to decide if an injunction is warranted I don't see this court battle taking too long to conclude.
BP saying he can talk about confidential agreement pertaining to sale of Incelldx
A joke-they offered to buy us and because they didn’t have a banker (remember) asked for a proposal. Happy to share since they broke confidentiality but not this number! Info@incelldx.com https://t.co/CZbssZiktP
— Bruce K. Patterson MD (@brucep13) August 3, 2021
One other-didn’t give them the validation for non-payment! We used PRO140 so you are saying the antibody is bad and doesn’t work. Last we had less than a third of samples for mono. As FDA said-incomplete! https://t.co/FnFPYxgmmT
— Bruce K. Patterson MD (@brucep13) July 17, 2021
You’re welcome! And yes, the days are about to get even crazier!
http://www.io.nihr.ac.uk/report/leronlimab-in-addition-to-antiretroviral-therapy-for-treatment-experienced-adult-hiv-1-patients/
http://www.io.nihr.ac.uk/wp-content/uploads/2021/07/17194-Leronlimab-in-addition-to-ART-for-HIV-Infection-V1.0-JULY2021-NON-CONF.pdf
Leronlimab in addition to antiretroviral therapy for treatment experienced adult HIV-1 patients
Posted by Diligent Cause on Reddit:
Facts Asserted in the Complaint support CytoDyn as owner of all rights to Leronlimab to treat Covid.
I'm not sure if anyone has posted the entire Complaint filed by CytoDyn against the 13D group (if so, I apologize for the redundancy), but here is a portion of the Complaint that is extremely relevant and specific to the issue of patent rights to the use of Leronlimab to treat Covid. I'm only including the most-relevant 3 paragraphs:
On October 10, 2018, Patterson and CytoDyn entered a consulting agreement (the“Consulting Agreement”) pursuant to which Patterson would aid CytoDyn on certain projects as an independent contractor. Among other things, Patterson agreed in the Consulting Agreement that he did not have “any right, title, interest in or ownership of Proprietary Information” and that any work product “conceived, made, reduced to practice, or discovered” by Patterson “in the course of any work performed for [CytoDyn]” would “be the sole and exclusive property of [CytoDyn].” The Consulting Agreement was later amended three times, each to raise Patterson’s compensation – ultimately, to $20,000 per month.
On July 17, 2019, CytoDyn and IncellDx entered a license and supply agreement pertaining to non-commercial grade quantities of the Company’s drug and related materials.
From October 2018 through May 2020, Patterson assisted CytoDyn with certain assay tests relating to HIV and COVID-19. In this period, Patterson also appeared in a number of interviews with CytoDyn executives to discuss CytoDyn’s ongoing research. For example, on December 10, 2019, Patterson appeared in an interview with CytoDyn CEO Nader Pourhassan regarding an ongoing breast cancer clinical trial. On April 2, 2020, in another joint interview,Patterson spoke about the results from a study involving patients that were experiencing severeCOVID-19 symptoms, and the impact of the Company’s drug, leronlimab, with reference to treatment of “cytokine storm.” And on April 30, in another joint interview, Patterson again described patient reactions to ongoing research using leronlimab. These interviews evidence Patterson’s ongoing role in CytoDyn’s clinical trials through mid-2020, and his role in helping to communicate with the Company’s investors regarding those projects.
?
For those who may question the veracity of the statements in the Complaint, I would assert from my perspective as an attorney that the attorneys at Potter Anderson & Corroon LLP and the Of Counsel attorneys at Sidley Austin LLP would not file a Complaint quoting a document as saying something unless they had actually seen the document and pulled the quote directly from the document. So, I trust that the Consulting Agreement says exactly what is stated in the Complaint. There will still be issues to litigation though, such as whether or not the use of Leronlimab to treat Covid was within the scope of the Consulting Agreement. Still, the agreement appears to cover work product conceived "in the course of any work performed for [CytoDyn]." There may be room to argue the matter, but I'd rather be on the side arguing that the Consulting Agreement means what it says rather than the side arguing that the Consulting Agreement doesn't cover this specific situation.
So, did I miss anything regarding those subpeonas?
Again, refusing to comply with a subpoena is not the same as having a subpoena request. Your previous statement can be bolded, underlined and font resized, but it still doesn’t make them equal. A subpoena does not equal guilt, not matter how hard you try to make it. Facts.
Reason does not equal guilt. Facts.
What’s NOT said is that probable cause is different than a subpoena. A request for records does not indicate guilt towards either party. It’s just a request for info. Glad to inform.
A legal dispute is hardly “lying”.
And that still doesn’t mean the company is dying.
By the way, how was the call?
So the company that just stated it has enough funding for the rest of the year is about to die?
This is not a trial meant to determine ststistical significance. It is to determine trial outcomes, where they best improve long hauler symptoms, along with markers that are effected by it.
Hence why it is “Exploratory”. Yes, personal testimony has to be taken with some grain of salt, but the negative view of this trial needs to be tempered with reality… this was Exploratory. And given the results, just with Leronlimab alone, there seems to be great benefit for Leronlimab, and even more so if combined with other treatments. But the mere fact that reported benefits we made with Leronlimab alone is very encouraging. I’m not expecting the stock to rocket with this news, but to dismiss the positives knowing it was merely exploratory is also clinically short-sighted.
I wish the best for your daughter in regards to long covid. It was uncertain in your post… was she in this specific trial?
I personally have a friend who is a long hauler. I highly doubt that if he had 18 out of his 24 symptoms improve, that he would consider that a failure.
Exactly.
“Prior to the commencement of this trial, the FDA advised us that our long-haulers trial is considered an exploratory trial;”
It did what it was designed to do: Explore the areas where and if Leronlimab would benefit in long hauler’s.
It was exploratory. It’s a shame that has to be reiterated.
The long term perspective of Leronlimab is staggering to say the least. The headway’s Cytodyn is making will only grow as positive patient outcomes continue to be reported.
Great ready.
“useless in a human” denies the trial data of HIV, Cancer, and the inability of the fda to concede the positives of the latest trial, while conveniently focusing solely on the negatives.
The fda would not allow the hiv trial nor the extended monotherapy group if it was a failure. aid you have proof it is a failure, show it. Otherwise, inaction fo the fda to stop Leronlimab in Cancer or HIV is proof enough that it works. Just because a small biotech has difficulty getting the paperwork of the bla correct doesn’t make the drug not work.
All IMO DURR
There is so much riding on the Mechanism of action in terms of its potential that makes Leronlimab a potential Big Pharma disruptor. But a cure here and there means a loss in revenue from those that profit from ongoing disease burden. This is why the cure for Hep C was such an unabated thing. There really was no cure or viable treatment for it. Unlike what is happening with Leronlimab.
Revenue coming sometime this week!
And they all go nowhere.
Ex President of the Philippines, Estrada, set to get a second dose of Leronlimab tomorrow.
True. But the these are effectively two distinct arguments. I was merely focusing on the fact that an EUA needs to be applied for. IF the fda then denies, we have an even greater problem that ‘suggesting’ they not apply, or recommending additional data. One is more heresay, the other is traceable, and verifiable.
But your point is taken too.