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7 hours ago, Taxguy said:

figured most have seen this CYDY press release this morning.  Surprised the Phase 3 in Mexico only going to have 25 people enrolled...maybe going thru the motions for approval?
 

 

CytoDyn and NIH of Mexico Complete Memorandum of Understanding to Conduct Small Covid-19 Phase 3 Trial for Severe and Critically Ill Patients

June 29, 2020, 3:00 AM PDT

VANCOUVER, Washington, June 29, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the Company and the Coordinating Commission of the National Institutes of Health and High Specialty Hospitals of Mexico (NIH) have entered into a Memorandum of Understanding (MOU) to conduct a COVID-19 clinical trial with leronlimab for severe and critically ill patients, with the potential to collaborate on additional COVID-19 trials. The NIH of Mexico is an organization that coordinates the main institutions of medical care and public research in the country. 

The MOU provides CytoDyn will supply leronlimab at its expense to the NIH and both parties are proceeding forward expeditiously to complete the mutually agreed protocol for this clinical trial.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented: “We are very pleased with the confidence demonstrated by the NIH of Mexico in our drug, leronlimab, and we are both very motivated to initiate this trial quickly to help mitigate the devastation of the COVID-19 pandemic on the citizens of Mexico. The anecdotal data received by CytoDyn (from over 70 COVID-19 critical patients who were treated under EIND in the U.S.) has impressed the NIH of Mexico and we believe with a small Phase 3 trial of only 25 patients, leronlimab could receive approval in Mexico very quickly. This Phase 3 trial is similar to our Phase 3 trial protocol in the U.S., with the exception of the number of patients.”

So much good news for CYDY. NP said the stock was very undervalued. 

Only negative on horizon is potential dilution and if so to what degree. Stock runup blunts investor concern for now regarding this.

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I will make a wager. If this stock hits $420.69 before this earnings call on March 31st, I will pass out 100 FBG subscriptions to the gents in the stock thread.

sponks

First reference.  Brings a tear to my eye. $CYDY #notselling

5 minutes ago, cubd8 said:

Are we looking at $20-22 a share for CYDY? How optimistic are we on their upside and what do you think it may be? It's been a great success so far.

was wondering the same.  I know everyone has their own #Chetmademillionairenumber, but once it actually uplists, is it reasonable to expect a pop into $20+ 

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@chet I’m a toe dipper but want to thank you for paying for my next taxidermy bill. The marital bliss that comes from having another dead buck head in our living room is a free bonus. 

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6 minutes ago, unckeyherb said:

was wondering the same.  I know everyone has their own #Chetmademillionairenumber, but once it actually uplists, is it reasonable to expect a pop into $20+ 

I remember a conference call a few months ago where NP said something along the lines of the stock is not worth double digits, not worth triple digits, but worth in the high triple digits.

maybe he’s on to something 😂 

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11 minutes ago, Taxguy said:

I remember a conference call a few months ago where NP said something along the lines of the stock is not worth double digits, not worth triple digits, but worth in the high triple digits.

maybe he’s on to something 😂 

As long as it gains 25% for 11 more days in a row we will hit triple digits 😂

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10 minutes ago, Taxguy said:

I remember a conference call a few months ago where NP said something along the lines of the stock is not worth double digits, not worth triple digits, but worth in the high triple digits.

maybe he’s on to something 😂 

Ummm, so if we say he means $750 a share that means he's valuing CYDY at double the market cap of Pfizer.

Let's just say that's unlikely.

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3 minutes ago, Sand said:

Ummm, so if we say he means $750 a share that means he's valuing CYDY at double the market cap of Pfizer.

Let's just say that's unlikely.

Not after Leronlimab makes Viagra unnecessary.

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12 minutes ago, Bob Sacamano said:

Not after Leronlimab makes Viagra unnecessary.

Well, it will for me, but I'm not sure N=1 will count for much.

(Though, as all the girls say,  it's one hell of a 1.)

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1 hour ago, ex-ghost said:

My stock app. says down $1.32 (-15.05%). Must be wrong.

 

EDIT: HAS to be wrong. CYDY will never be red again.

Can’t trust AH prices on OTC. I’d imagine the delays would be long and it’s very small volume. It was red a few days ago and it popped at open.

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11 minutes ago, Sand said:

Ummm, so if we say he means $750 a share that means he's valuing CYDY at double the market cap of Pfizer.

Let's just say that's unlikely.

This is why I asked the question earlier as to what is the right value if/when things go right.

seems like the thread consensus is if they announced favorable results and the assumption this was a shoe in for FDA approval a 15B valuation wouldn’t be out of line.  That’s $22 a share.

If they are able to forecast Annual sales of what they already have on order that would be reflective of a 30B valuation or $44 a share.

needless to say if things went parabolic to the 40’s it might be time to start thinking..... let’s hope we have that conversation someday.

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What's funny is 90% of FBGs have no idea what's happening in here.... :lol: 

 

If this thing hits those numbers discussed earlier, this thread could profit $50-75MM off this damn stock. Might be an Fantasy football forum thread record. :lmao:

 

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On 6/26/2020 at 9:26 AM, chet said:

In terms of the vote, I am initially inclined to vote no.  They haven't given any specific reasons for the increase and to me, it seems likely that they will pay themselves in stock.  I am all for executives getting rich but I think they should do it more by increasing the stock price rather than paying themselves stock bonuses.

We have just about a month to decide.

Chet

I would appreciate it if you kept us updated as we go along regarding your thoughts on the stock increase (dilution) proposal. I haven't voted yet on it and certainly would to hear the latest as to your thoughts before voting. Thanks

Do they really need the money? How much stock will be actually issued? Projected effect on SP? Other consequences of the dilution? These things are on my mind.

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2 minutes ago, [icon] said:

What's funny is 90% of FBGs have no idea what's happening in here 😂

I didn't until last week.  I didn't really have anything set up and i know very little, so I thought I would come in here and see how things were.  I read through a bunch, but a lot of it was a foreign language to me.  I saw all the excitement for CYDY and dropped a small deposit into an old Roth account I had to call a phone number to recover.  I now own a whopping 100 shares of CYDY which I got today at 7.60.  I tried to buy Friday for a buck less, but funds didn't go through until this morning.  I even tried to buy first thing this morning, but had to wait for the damn central time bank to open.  That cost me about $ .50 a share.

So,  I will not realize the millions that I hope some people in here get to, but I will have a small stake in the ride and we will see if I can put that money to good use in the next big stock that comes through these boards.  If it is even half as exciting as CYDY, then I would be thrilled.

Its been fun to just see everyone doing well.  

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56 minutes ago, fantasycurse42 said:

One serves a gross grease bomb with some chipotle dipping sauce accompanied by a mediocre steak, the other is going to save the world. 

Oh.....YOU!  

That steak is entirely decent and that onion thingamajig is downright delightful!  

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7 minutes ago, Moonlight said:

Chet

I would appreciate it if you kept us updated as we go along regarding your thoughts on the stock increase (dilution) proposal. I haven't voted yet on it and certainly would to hear the latest as to your thoughts before voting. Thanks

Do they really need the money? How much stock will be actually issued? Projected effect on SP? Other consequences of the dilution? These things are on my mind.

He’s been giving us tons of updates everyday!

#allhailchet

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24 minutes ago, The Ref said:

This is why I asked the question earlier as to what is the right value if/when things go right.

seems like the thread consensus is if they announced favorable results and the assumption this was a shoe in for FDA approval a 15B valuation wouldn’t be out of line.  That’s $22 a share.

If they are able to forecast Annual sales of what they already have on order that would be reflective of a 30B valuation or $44 a share.

needless to say if things went parabolic to the 40’s it might be time to start thinking..... let’s hope we have that conversation someday.

I think many of us want a crazy robinhood 400% gain so we can sell sell sell............then buy again when it drops from 30 to 10

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Thinking out loud, a bit like buying lotto tickets when it's $500 million.

COVID is the play that allows CYDY to get some revenue traction in the next few months. $50 share with uplisting?
HIV is the play that demonstrates its safety, and provides some revenue generation opportunity. $75/share?
mTNBC - Metastatic Triple-Negative Breast Cancer is what we're here for. $1,000/share?

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CytoDyn and NIH of Mexico Complete Memorandum of Understanding to Conduct Small Covid-19 Phase 3 Trial for Severe and Critically Ill Patients

 June 29, 2020 Stock Day Media 3700 Views conduct, covid19, cydy, memorandum, mexico, NIH, phase3, understanding

VANCOUVER, Washington, June 29, 2020 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the Company and the Coordinating Commission of the National Institutes of Health and High Specialty Hospitals of Mexico (NIH) have entered into a Memorandum of Understanding (MOU) to conduct a COVID-19 clinical trial with leronlimab for severe and critically ill patients, with the potential to collaborate on additional COVID-19 trials. The NIH of Mexico is an organization that coordinates the main institutions of medical care and public research in the country. 

The MOU provides CytoDyn will supply leronlimab at its expense to the NIH and both parties are proceeding forward expeditiously to complete the mutually agreed protocol for this clinical trial.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented: “We are very pleased with the confidence demonstrated by the NIH of Mexico in our drug, leronlimab, and we are both very motivated to initiate this trial quickly to help mitigate the devastation of the COVID-19 pandemic on the citizens of Mexico. The anecdotal data received by CytoDyn (from over 70 COVID-19 critical patients who were treated under EIND in the U.S.) has impressed the NIH of Mexico and we believe with a small Phase 3 trial of only 25 patients, leronlimab could receive approval in Mexico very quickly. This Phase 3 trial is similar to our Phase 3 trial protocol in the U.S., with the exception of the number of patients.”

About Coronavirus Disease 2019
CytoDyn has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and enrollment continues in its Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) and BLA Submission for the HIV Combination Therapy
The FDA has granted a “Fast Track” designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the FDA deems a BLA submission complete, it sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA. The Company filed a request for Priority Review designation for its BLA to shorten the FDA’s review time from 10 to 6 months, an FDA goal for BLA applications given Priority Review designation.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. 

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted “orphan drug” designation to leronlimab for the prevention of GvHD.

About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients, and submitted additional FDA requested clinical datasets on May 11, 2020. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.

Forward-Looking Statements 
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict.  Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company’s forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company’s cash position, (ii) the Company’s ability to raise additional capital to fund its operations, (iii) the Company’s ability to meet its debt obligations, if any, (iv) the Company’s ability to enter into partnership or licensing arrangements with third parties, (v) the Company’s ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company’s ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company’s clinical trials, (viii) the results of the Company’s clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company’s control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTS
Investors:
Cristina De Leon
Office: 360.980.8524, ext. 106
Mobile: 503.214.0872
cdeleon@cytodyn.com

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Cramer's COVID 19 Underperformers

not the gospel, but a bunch of strong names to consider. Maybe not value, but not as over-valued as most

Crown Castle

Campbells

Verizon

Walmart

Centene

Johnson & Johnson

AMD

Barrick Gold

Conagra

Proctor Gamble

Pfizer

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Kinda thinking I should take a day trip up into Vancouver, WA as the official FootballGuys.com field reporter on stonks and kick the tires on CytoDyn since it's right in my backyard.  

I mean.....I am a shareholder.  

Also maybe our hedge fund is curious.....maybe even bi-curious, I dunno.  

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Another article

One drug that has shown promise in early trials has proven successful against another deadly virus, HIV. It is called Leronlimab, or Pro 140, and studies have revealed that it can stop the inflammatory reaction that overwhelms the lungs and makes breathing impossible.

“This is an interesting drug, it’s one that I’m very interested to see more of what happens. It seems to block that cytokine storm and it seems to temper it down so that people can get through the viral infection and not have their own body attacking itself,” says Dr. Manisha Juthani, Yale Medicine Infectious Disease Specialist and Associate Professor at Yale School of Medicine.

 

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1 hour ago, The Ref said:

The stock was $4.16 a week ago.

No ####. I sold all my crap LK and just decided to use it to buy 100 shares of CYDY in the 4s. I’m sitting on a lot of shares and haven’t added since 2.90s except for that little buy only because I was tired of seeing LK. I do wish I bought more but it’s still a risk so comfortable with it. I crossed the $100k in profit line today. That’s ridiculous and I probably shouldn’t say crossed, maybe blew through or exploded through would be better.

Thanks @chet you’ve effectively paid for the rest of my oldest’s 3 remaining years of OOS tuition. I’m all for CYDY paying for the other two as well!

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1 minute ago, stbugs said:

No ####. I sold all my crap LK and just decided to use it to buy 100 shares of CYDY in the 4s. I’m sitting on a lot of shares and haven’t added since 2.90s except for that little buy only because I was tired of seeing LK. I do wish I bought more but it’s still a risk so comfortable with it. I crossed the $100k in profit line today. That’s ridiculous and I probably shouldn’t say crossed, maybe blew through or exploded through would be better.

Thanks @chet you’ve effectively paid for the rest of my oldest’s 3 remaining years of OOS tuition. I’m all for CYDY paying for the other two as well!

I'm now rich, but I'm still afraid. :confused:

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16 minutes ago, General Malaise said:

Kinda thinking I should take a day trip up into Vancouver, WA as the official FootballGuys.com field reporter on stonks and kick the tires on CytoDyn since it's right in my backyard.  

I mean.....I am a shareholder.  

Also maybe our hedge fund is curious.....maybe even bi-curious, I dunno.  

You gonna wear dark clothing so that they can see you?

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18 minutes ago, General Malaise said:

Kinda thinking I should take a day trip up into Vancouver, WA as the official FootballGuys.com field reporter on stonks and kick the tires on CytoDyn since it's right in my backyard.  

I mean.....I am a shareholder.  

Also maybe our hedge fund is curious.....maybe even bi-curious, I dunno.  

Be careful, those Couvtucky streets are rough.

 

15 minutes ago, Bob Sacamano said:

Is it P/E?

:lmao:  Excellent Forrestmail call out.

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22 minutes ago, eaganwildcats said:

Another article

One drug that has shown promise in early trials has proven successful against another deadly virus, HIV. It is called Leronlimab, or Pro 140, and studies have revealed that it can stop the inflammatory reaction that overwhelms the lungs and makes breathing impossible.

“This is an interesting drug, it’s one that I’m very interested to see more of what happens. It seems to block that cytokine storm and it seems to temper it down so that people can get through the viral infection and not have their own body attacking itself,” says Dr. Manisha Juthani, Yale Medicine Infectious Disease Specialist and Associate Professor at Yale School of Medicine.

 

Manisha Juthani

I ALWAYS want to know who these people are. Excellent credibility..

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16 minutes ago, Sandeman said:

We must be getting on some radars this week. I would not be surprised to see a flurry of media mentions for LL's effectiveness. The stock price must be bringing more attention to the story.

symbiotic

 

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2 hours ago, kevzilla said:

When is not until leronlimab finishes kicking Covid's ###.

Where is the lobby bar in the Waldorf-Astoria on the Vegas Strip, just before sunset.

I think a part of this party would have to take place at the onion .

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Add this to the FWIIW talk on price..... seems like most of the sensible people on yahoo finance (grain of salt) have sights set on that $15B/$22 share numbers that we have kicked around.

 

 

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3 minutes ago, The Ref said:

If it wasn’t God love you

Tomorrow might be bigger.

Quote

Institutional Investing End of Day Update 6/29/2020: Ok, trying again. Close was $8.77 up 26.55% from Friday's $6.15 on a hefty total volume of 18,050,864. But what about institutional trading?

Well, it was an equally hefty 5,142,949 shares constituting a nice 28.49% of the trading volume similar to Friday. Interestingly, in the last 1/2 hour, institutional block trading rode the price up from $8.25 to $8.81 (4 cents higher than the ultimate close. The acceleration from $8.25 to $8.81 was kicked off at 3:31:02 pm with a 200,000 share purchase at the Ask price of $8.25 (for $1,650,000) and concluded with 3:58:39 pm20,000 share purchase at $8.81 ($16,500). There were 24 trades in between of which 17 were at the Ask price, 2 were in between, and only 5 were at the bid price. Looks like the institutions are very bullish just like us.

Of course, all this is preliminary. The party is just getting started and won't get really serious until the "expected" materially successful results of the 2 trials are published in the next week or two. At least "expected" by the retail investors who followed Dr. Patterson's analysis and all the clinical study results closely since the Montefiore results were first reported if not earlier and have been buying the stock since then. 

The rapid 26.55% acceleration of the share price growth today suggests that more investors, including the "professionals", have figured out that leronlimab is a slam dunk to be a safe and effective treatment for Covid 19 and HIV and likely to be successful with some of the other indications listed in the Cytodyn Pipeline page.
No one wants to be left behind!

Price Prediction: I know, I was wildly off with my last prediction on Wednesday when I predicted a jump from $6.15 to $8 or $9 on Thursday. But looking at it longitudinally, which I now prefer to do, I was only off by 2 trading days, Thursday and Friday. So, I will take another shot at it. For tomorrow, since the word appears to be spreading and FOMO before the trial result announcement is still operative motivation, I will predict $9.90 to $11. You can take that to the bank (but don't try to deposit it yet:)).
Less

 

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9 minutes ago, chet said:

Pretty sure today was my biggest one day gain ever. 

 

Watch it. They'll be setting up guillotines in your front yard before you know it.

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7 minutes ago, chet said:

Where's Melly?

Twitter, instagram and my text messages. I forgot to tell him about this. 
lucky guy distillery on insta, he is opening his own distillery in MN.  Guy whitehead on Twitter.

if covid mellows at the end of November I will get you a private tour of the Xmas ship when it pulls into navy pier. I may even fly out to do it myself.

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