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His right-hand woman Melissa DeRosa has been responsive to me on Twitter (regarding a separate matter). May be a good way to reach out... https://twitter.com/melissadderosa
Cuomo 100%, Newsome doesn’t have the backbone to do something this wild.
If Cuomo thinks this can drop the death rate down to 0, he will make it happen yesterday. I’m a New Yorker. 100% has this guy been doing everything he can to get that death rate to 0. We have some of the toughest restrictions right now. Every traveler flying in has to do a mandatory 14 day quarantine. You do not step off an airplane in a NY airport without filling out forms of where you came from and where you are going. Trust me, he is the guy you want to get his hands on this. Don’t let up with the phone calls and emails. Give him all the DD you have. He will make this happen.
Did you also catch where AF hijacked Dr. Yo's thread? Adam seems to be trolling anyone who's seemingly pro-CYDY. I'm dying to know what precisely is behind AF's absolute obsession on CYDY. 8/23 thread her where AF trolls Dr Yo twice:
Wow. Old man Adam plunks himself on Dr. Yo's feed w/ the sole purpose of being obnoxious. Dr. Yo doesn't punch back but replies in a classy, measured way. Adam isn't even sophisticated enough to reply. Douchebag personified.. and that's prob his only path into the promised land
— sara jaye (@sarajaye212) August 26, 2020
Everyone... Adam Fraudstein responded to one of Thomas Landstreet’s tweets challenging him about Leronlimab... I re-exposed his interference with an FDA clinical trial. If you’re on Twitter, please go to Fraudstein’s post and shove Leronlimab straight up his ass!!!!!!!!
Uplisting being driven/handled by Mike Mulholland and attorneys, not NP... not to say that's foolproof but I don't expect dropped balls on the nasdaq application
Amatuer17
Post # of 110802
M2M EUA is gone.
Uplisting - this is 5th week and if there is no news this week - that is not happening. They possibly did not meet prerequisite or like NP style, he did not file right paperwork.
The only news of importance is 195 patient enrollment - supposed to be completed by Aug end.
He is also an advisor to the FDA, and has been a medical advisor for Cytodyn for years.
Massimo Cristofanilli, the lead researcher listed in the Abstract is solid validation that Leronlimab is a real possible game changer when it comes to mTNBC. A google search will tell you all you need to know about him.
IF this rumor is true, I'd think that Bruce has many more direct and indirect contacts to the OWS group and subgroups. Would make total sense that a Bruce person strung the meeting together - if that's the case, BP+NP both attending would make very good sense. Either way, true or not, it'd be nice to see the boys in the band back together.
Since this possible meeting is out of left field, I am not surprised with BP being invited. Nader is not the medical professional and the people making the decisions probably want to better understand the mechanism. BP after the Ted Talk has the reputation. Considering all of the consternation expressed at previous government hand outs from OWS, they might be crossing a few t’s.
Appreciate this a lot more Monroe1. Thanks.
Mellisa Dodd, Cytodyn's new PR person has some studying to do like some shareholders unfamiliar with what is going on.
An update today from Olive re: Holly
(from https://www.gofundme.com/f/HollysCancerDrugTrialCampaign)
by Olive O'Sullivan, Organizer
Good morning from West Cork.
Here is the news!
Our Holly is meet her Oncology team today in St James hospital at 0900 to discuss her Chemotherapy plan .
Her consultant Dr Kennedy is going to plan her future chemotherapy schedule with Holly .
Holly messaged me yesterday to say she is making progress, slowly but moving forward.
Her twice a week #leronlimab was administered yesterday as per her scheduled protocol.
She is researching a European Specialist for another supportive opinion and exploring other supportive treatments we can get our hands on.
For now, we will keep the fundraiser opened to help her in her decision process and to support her in whatever decision she makes - so that it’s one less thing for her to worry about.
She loves being home, with Derek and her little boy Andrew.
She wants to express on here, her profound gratitude to everyone who have stood by her .
She also wanted to reach out and express dismay at the doubts that Adam Feuerstein attempted to undermine in me/you and her decision to choose #leronlimab as her trail drug of choice.
Thankyou again from the bottom of our hearts.
Big hugs from beautiful ( but wet) West Vork today.
Olive x
Sorry but 3x is right on with tonight's posts. NP is charismatic, passionate and works very hard. But come on - he's learning on the job as a CEO and as a biotech player in a very tense world pandemic that is touching on every geopolitical nerve. NP's errors, blabbering and putting of carts-before-horses have made the company lose time, credibility and probably significant dollars. Glad someone has knocked some sense into him regarding tossing out hopeful timelines and relaying nonsense which fuels the Adam Fibbersteins of the world. Were it not for this amazing molecule, I would've walked long ago.
So, yes, they may have a plan, but do they have the mental tools to execute it? I tend to doubt it. My wish is that the current CD10 data and the midpoint of CD12 are enough to spur licensing offers from experienced players who know the drill.
Do you realize that your entire post is speculating?
Could you please discontinue this type of reflective reasoning?
It’s all based on what if and that CYDY management is not experienced enough.
I think they know what they’re doing and they have a plan.
Try to let it unfold.
It could very well be ( something I've believed for a while) - they're hoping to time this with other news, whether it be uplist, BP partnering, or data on CD12. There's a reason that they're sitting on this. Behavior change in sputtering out piecemeal news has shifted. Something's up. And I think it's really good.
chuck29 Monday, 08/10/20 08:07:03 PM
Re: scatdad2 post# 104068 0
Post # of 104089
you mean to tell me that its been almost 3 weeks after the safety results came out and still no efficacy results. nader is hiding something bigtime
Adam Feuerstein's bosses on twitter; tell them how you feel: @GideonGil @rickberke
I am demanding answers as to why this is allowed to continue. Started with a tweet. Emails and phone calls are next. If I'm not satisfied, it's on to STAT's advertisers.
Wrong. Patterson is a shareholder. Jay Lalezari is not.
Grip it and Sip It Monday, 08/03/20 05:41:32 PM
Re: lostmyballs post# 101690 0
Post # of 101706
He doesn’t own any shares! He’s emphatically declared that previously.
That's a convo that needs to happen. I've also tried to link NP up with PR's I work with. Crickets. May I suggest sending to Scott Kelly and Mike Mulholland? NP may take the suggestion personally as he is a passionate and emotional guy.
I got an ex-Amgen VP Comms to listen to BP's TED talk and she is psyched. Would be a perfect fit for emergency comms leadership - from broad comms strategy to mgmt coaching to writing press releases.
Pls contact me if you can confidently reach NP - I've sent an email and a linkedin message.
Thanks but as a shareholder I'll take action whenever I feel like it. Especially when said ideas could raise the company's profile or encourage a climb in SP. GLTU!
Stop pestering NP with unnecessary emails. They said on the call they will PR the advisory board in next week or so.
Superb - let's amplify this idea...
I sent an email to Nader and told him they should submit a press release regarding the Scientific Advisory Committee’s newest members.
Plainly and simply, any company who communicates to the public should have a Public Relations or Communications department - or at the very least, a paid consultant or an agency of record. Not only do those people strategize the communications policies and schedules, they know how to write from the lens of putting the company best-foot-forward in an understandable, translational and concise manner. They also know how to media-train their execs who may be consumer-facing on live television. They also have longstanding media relationships they can leverage on behalf of their clients. Not that deep. It's one of the most important investments that Cydodyn could make.
Here’s the rub. Nader is a gun slinger and shoots from the hip w no fear. He’s dangerous but he’s effective in selling the story. I’ve watched him do this gig for a long time.
The issue is the company PR’s are very important in terms of accurately and unambiguously representing the facts. CYDY gets an F for their performance on this front. That’s on Nader and the BOD. Why would anybody with half a brain want to piss on there hard work. No excuses — get it right.
The author of the article should write CYDY's PR's. Look how clean and concise this is.
https://www.targetedonc.com/view/limited-toxicity-seen-with-leronlimab-in-mild-to-moderate-covid-19
Here's my political solution: Patterson/Landstreet 2020.
That is all.
Here is the 2nd half of what Thomas Landstreet said on OAN
"Depends on how this news out of this little company CytoDyn comes out tomorrow with this drug Leronlimab...if it's really what I think and what I read it's gonna be a game changer and I think the market might rally and the COVID trade will somewhat unwind...where basically people are buying stocks like zoom that are all based on us being locked down again...I think any minute you could come up with the dark horse solution like a CytoDyn...I do not think it's coming from Astra Zeneca, Moderna, Gilead...just a little note...out of the 20 some people on the NIH panel that is set up to review vaccines...8 of them work for Gilead...so when I say there is an inside game...when I say these companies are politically connected...that's what I am talking about"
Mike m said it
and did you hear NP say it could go to $3 and not prevent the uplisting?
Plus, if early results can be provided from CD12 to FDA - and if all datasets showed similar promise - could that collective result call for a smaller pool for M/M P3? Is this a possibility?
Phase II trials are usually about assessing dose-response. That's the main point I'd add to your summary.
Typically there will be 2 or even 3 dose levels given to subgroups of the treatment arm. The objective is to set the optimal dose for the much larger, more costly Phase III trial.
Leronlimab's Phase II is logically like a a Phase III, with only one dose level. For that reason, I could conceive of the FDA extending this trial into a II/III, but not likely requiring a start-over.
Do you really need, say, 400 patients? Not if the result is pronounced and consistent. Statistical precision only increases with the square root of patients: 4x patients ==> 2x precision.
Put another way, if a drug's underlying effect is twice as large, a 100 person trial has the same chance of being significant as a drug with the lower effect in a 400 person trial.
Patterson to appear on DrBeen - roll to 16:14
https://www.facebook.com/watch/live/?v=1071598326576194&ref=search
Excellent. That makes all the difference. His initial tweet seemed a bit harsh and not at all like his usual enthusiasm for Leronlimab. THANK YOU Smiley Riley
I have a few personal friends - a heart surgeon, a psychiatrist, and a family friend who's a senior exec at a small US Pharma co. In general terms, they told separately me not to be surprised if any promising drug was delayed or suppressed in favor of big Pharma. Not new news, of course, but interesting to hear from people closer to the facts than me. Carry on.
All I'm saying is not to expect any favors from the FDA. In fact, we shouldn't even expect fair treatment from those hacks. And the Gilead report, likely bogus, still gives them even more reason to string us along with request for another trial at least. I don't like it one bit, but none of you are even allowing for the possibility of this happening.
I don't disagree! But if you read the OP again, what I am pointing out is the fact that many weeks ago, NP touted and rambled about the BP paper and how it would be published "next week." FF to today, and he won't touch the topic and says only BP can comment since he is the lead author. Is that not a little strange?
What’s the big deal? BP doesn’t work for CytoDyn and has nothing to do with business updates. They utilized BP to explain the MOA and what he discovered. He did that multiple times. How many more times do we need to hear that? Should BP still be on the calls to talk about the MOA that we have already learned? BP has nothing to do with business updates. His company is contracted by CytoDyn to analyze the blood samples, which I’m certain he is busy doing
Sorry if my conjecture ruins your ticker tape parade. But it happened, and if you can't find the original video where NP first announced that BP's paper would be published "next week," I will try to find it for you. But it doesn't matter because he owned it, and now won't comment on it. All I expect is a little consistency.
Exactly. Plus, why did he shrug off answering about the Dr. BP preprint? NP said that since BP is the primary author, only he would be attributable to giving an update. But, around 8 weeks ago, it was NP who was directly touting that the paper would be published "next week." Y'all remember that?
Actually I suspect something is not right between NP and Dr BP.
NP has stopped mentioning his name - even Dr L is out of picture.
NP promotes those 3 other Dictors
Not really a win, sorry. Lenzulimab, not Tocilizumab, is who we need to worry about as a competitor.
I own both. Glad to hear about the spinoff.
This is the post I didn't know I needed today!! Actually laughing out loud to myself.
More importantly Yi Chen's success rating for his overall recommendations is only 49%. So he an experienced analyst that has a worse track record than the weather man, your local weather man.
I'm taking it back to bbcbro's post a week ago as to Trump's forthcoming 'therapeutics' announcement; IMO of course:
ACTIV is planning five master protocol trials, the first of which will test three host-targeted immune modulators against TNFa, CTLA-4 and CCR2/CCR5. The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) consortium is led by NIH and managed by the Foundation for NIH. Its members include 18 biopharma companies, FDA, CDC and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR). BARDA is part of ASPR (see “ACTIV Coming into Focus”).
“Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn't describe the study in any further detail because, they said, its disclosure would be "market-moving”
https://www.google.com/amp/s/www.nbcnews.com/news/amp/ncna1232884
Oh boy... Dr. Pourhassan's going on Dr. Been's facebook live on Saturday night. Dr. Been is incredibly smart and was an early Leronlimab supporter so no shade whatsoever - but how is this appearance going to be helpful to the SP? Ughhh why??? Silence would be so much better for now...
https://www.facebook.com/drbeenmedical
I signed up for Tim Sykes' daily email. We are one of five stocks he mentioned today:
CytoDyn Inc (OTCQB: CYDY)
CytoDyn Inc. is a clinical-stage biotech with several drugs in the pipeline. During the coronavirus pandemic, much of the PR focus has been on leronlimab. In April, the drug showed positive results for treating COVID-19 patients.
On June 19, CytoDyn presented on the Wall Street Reporter’s “Next Super Stock & Investors Discovery Day” livestream. On June 29, CytoDyn and the NIH of Mexico announced a small phase 3 trial for severely ill COVID-19 patients.
The stock kept going. But then the inevitable happened. I was watching this one, waiting for a big morning panic. It came literally as I was writing this. Check this out … It’s a tale of two charts, just minutes apart...
Take a look at the CYDY three-month chart on the day of the panic, before the panic:
Alternate text
CYDY chart: 3-month, daily candle, top penny stocks to watch July 2020 — courtesy of StocksToTrade.com
And now … after the panic…
Alternate text
CYDY chart: 3-month, daily candle, after a big morning panic — courtesy of StocksToTrade.com
That big red candle on the right is the panic. Now take a look at the June 30 intraday chart. Memorize this chart! Study it like crazy.
Alternate text
CYDY chart: June 30 intraday, 1-minute candle, perfect morning panic dip buy — courtesy of StocksToTrade.com
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Students report crushing it on this panic both short and long. For me, I bought the dip and made $23,220.*
(*My results are not typical. I have exceptional knowledge and skills developed over time. Trading is risky and most traders lose money. Do your due diligence and never risk more than you can afford.)
So why is this stock still considered a top penny stock to watch in July 2020? Two reasons: first, you need to study this panic. It was PERFECT! Second, the CYDY bounce was huge — back to $8. Plus, it has a history of multi-day runs. I’m watching for another big dip buy opportunity.
Now for the last of our top penny stocks to watch this month...
NP, BP, et al are privy to the data as it comes in. They are NOT privy to whether each dataset comes from Leronlimab pts or placebo pts. NP would never ever have brought this up if be believed that the SAEs came from the dosed pts. This is Nader being Nader.
ut5678 Wednesday, 07/01/20 02:45:32 PM
Re: Amatuer17 post# 89648 0
Post # of 89742
I went back and listened on the severe/critical data. He stated that “quite a few deaths reported as SAE’s”. It doesn’t sound like there were any other SAE’s besides the death. My question is this...does the company know if the reported deaths/SAE’s were actually from patients taking Leronlimab or could some/several be reported from the placebo leg? Info is at the 4:54 mark on the video.
For our purposes, Tocilizumab is a non-starter since it's an IL-6 inhibitor only. Leronlimab targets IL-6 and the CCL5 (Rantes)/CCR5 pathway.
__________________________________
Borel Fields Tuesday, 06/30/20 11:41:01 PM
Re: bobshmob post# 89359 0
Post # of 89432
Some good outcomes on tocilizumab, but not randomized, as paragraph 2 of the Lancet paper notes: "a non-randomly selected subset of patients also received tocilizumab."
No question, the list of possible storm-treating drugs is narrowing to leronlimab (first with randomized trial results), tocilizumab and lenzilumab. And everyone understands we need storm-treating drugs.
Jimmy667, the original post was also mine. I am doing my own DD and was simply digging in after reading the post which said BARDA has a focus on a "CCR2/CCR5" MAb. Prior to this, I was unaware that such a MAb existed. A quick google search led me to the BMS trials. I asked for feedback on my finding. With all due respect, there is no other agenda for me except to become knowledgable on what is my most sizable investment in 10+ years of stock trading.
Count on this - if I find something relevant (good or bad) - I'm gonna post it.
jimmy667 Sunday, 06/28/20 02:43:29 PM
Re: SaraLovesYou post# 88192 0
Post # of 88225
Two reasons the prior BMS trials were discontinued. Safety and Efficacy. One or both. Meanwhile CYDY is hitting on all 24 cylinders for safety and Efficacy. The original post is typical for naysayers to invent some supposed competition to incite FUD. Many many loser drugs and companies have been posted about in such a manner over the years to oppose strong contenders and they have all proven to be pretenders.
The Defense Production Act could fast-track the process and eliminate the usual roadblocks.
Chuckles759 Sunday, 06/28/20 02:00:59 PM
Re: Scooter McCabe post# 88199 0
Post # of 88204
No doubt the line to partner with CytoDyn would suddenly be a mad scramble.
But I recall NP saying that it took over a year to get the tech transfer and processing with Samsung Biologics up to FDA standards. I'm not sure how much of that "process" you can waive or shorten if using another CMO.
It's certainly not like finding that your normal machine shop's lathe is broken and you have to go down the street to their competitor with your blueprints to keep production going. I really wish it were that easy.
Actually five trials are currently recruiting for BMS813160 for various cancers as a combo therapy. Medical folks - can you speak to how this compares to Leronlimab? To recap, BMS813160 targets CCR2/CCR5. Certainly there will be other comparable such as 1L-6 inhibition, etc.
Active trial links: https://clinicaltrials.gov/ct2/results?cond=&term=BMS813160+&type=&rslt=&recrs=a&age_v=&gndr=&intr=&titles=&outc=&spons=&lead=&id=&cntry=&state=&city=&dist=&locn=&rsub=&strd_s=&strd_e=&prcd_s=&prcd_e=&sfpd_s=&sfpd_e=&rfpd_s=&rfpd_e=&lupd_s=&lupd_e=&sort=
>>>>>
The only active clinical trial for BMS drug is scheduled for completion in 2015. The other two trials were closed out a few years ago.
Clinical Trial
NCT Number Sponsor Condition Start Date Phase
NCT03496662 Washington University School of Medicine|Bristol-Myers Squibb|Barnes-Jewish Hospital|National Institutes of Health (NIH)|National Cancer Institute (NCI)
Pancreatic Ductal Adenocarcinoma
August 31, 2018 Phase 1|Phase 2
NCT01049165 Bristol-Myers Squibb
Accelerated Intimal Hyperplasia
February 2010 Phase 1
NCT01752985 Bristol-Myers Squibb
Diabetic Kidney Disease
March 18, 2013 Phase 2
Thanks bbcbro for this deep dive which I inhaled last night - the thing that throws me is that they specifically mentioned "CCR2/CCR5." You correctly state that the only listing on the excel sheet for any chemokine receptor is Leronlimab (line 181). I wanted to see if any CCR2/CCR5 MAbs were in trials and see the Bristol Myers Squibb is actively in five various cancer trials with BMS-813160 (as a combo therapy).
Can someone smarter than me comment as to whether this is a competitor to Leronlimab (as far as Covid indications at minimum)?
trials listed here:https://www.cancer.gov/about-cancer/treatment/clinical-trials/intervention/ccr2ccr5-antagonist-bms-813160
bbcbro's post:
BARDA no longer funding immunomodulators as support for the therapeutic class to treat COVID-19 grows
According to BioCentury’s COVID-19 Resource Center, there are more than 100 immunomodulators and immunosuppressants in the clinic to treat COVID-19. New entries this week include therapies from Evelo Biosciences Inc. (NASDAQ:EVLO), Theravance Biopharma Inc. (NASDAQ:TBPH) and Fulcrum Therapeutics Inc. (NASDAQ:FULC).
HHS’s Biomedical Advanced Research and Development Authority updated its website early this month to reflect that it is no longer accepting funding proposals for immunomodulators to treat COVID-19, or therapeutics targeting lung repair for the disease. It did not give a reason for the change.
The about-face follows the U.K. approval of anti-inflammatory steroid dexamethasone, which reduced mortality by 35% in ventilated COVID-19 patients (see “Master Protocol Shows Survival Benefit”).
The change also comes as ACTIV -- a COVID-19 consortium that counts BARDA’s parent agency as one of its members -- readies to launch a master protocol of immunomodulators this month.
The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) consortium is led by NIH and managed by the Foundation for NIH. Its members include 18 biopharma companies, FDA, CDC and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR). BARDA is part of ASPR (see “ACTIV Coming into Focus”).
ACTIV is planning five master protocol trials, the first of which will test three host-targeted immune modulators against TNFa, CTLA-4 and CCR2/CCR5
CCR5 (CD195) - CC chemokine receptor 5
C-C chemokine receptor type 5, also known as CCR5 or CD195
https://www.biocentury.com/article/305582/barda-no-longer-funding-immunomodulators-as-support-for-the-therapeutic-class-to-treat-covid-19-grows
The only CCR-5 inhibitor (there are no CCR-2) in clinical trials? You guessed it.
https://www.biocentury.com/clinical-vaccines-and-therapies
Policy nerds: Can the Defense Production Act be instated for drug manufacture at this time? If they did it for ventilators, could they do it for pharmaceuticals?
Hi all - nice to finally be here rather than lurking only. There are some great minds on this board.
I've been in and out of CYDY for about 2 years but have been unhealthily obsessed with it since March 2020. 26,500 shares across 9 different buys. Cautiously hopeful. GLTA!