While we await up-list for CYDY, this is another Paulson PIPE graduate in the monoclonal antibody space uplists next Monday. RZLTD (RZLT after Monday). This is a phoenix out of the ashes.

This is the PR I want to see from CYDY:
https://www.rezolutebio.com/news/press-releases/detail/268/rezolute-announces-uplisting-to-the-nasdaq-capital-market

CYDY: Back to $2.25 Friday unless there is real news. I may buy more if NP hires Chief Marketing Officer to un-f*%k the branding and communications blunders.
Perception of value= SP.
Updates= I am gonna ask that guy/gal out next week.
News= we eloped last weekend.

This is great news for LL- one more competitor moved off the field. Not so good for the S/C pt.s that signed up for the clinical trial- Godspeed to them.. But maybe, just maybe, some MD's can add them to the LL trial?

"The partial study hold indicates that the promising class of monoclonal antibodies might not work in hospitalized patients with the most severe cases of Covid-19. On Monday, a study of Eli Lilly’s monoclonal antibody in hospitalized patients was terminated after it was determined the drug was unlikely to provide a benefit."

https://www.wsj.com/articles/trial-of-covid-19-antibody-drug-regeneron-is-halted-in-sickest-hospital-patients-11604071118?mod=hp_lead_pos6

Just to hedge my bet on CYDY I bot stock in J&J, makers of Visine because there definitely demand for those of us trying not to blink.

Dr.  Nesheiwat mentions LL  at 5 min point in this video

Oh, ya. And more COVID:

Today a peer review publication in the journal Clinical Infectious Diseases: "Clinical Characteristics and Outcomes of COVID-19 Patients Receiving Compassionate Use Leronlimab". Commenting on this article, Dr. XYZ, an infections disease specialist at ZYX Hospital stated: "Leronlimab, as a treatment for Critical COVID patients, appears to be saving lives. I am pleased to here that the clinical trials are well underway and the DSMC recommendations to Cytodyn on their interim analysis of the Leronlimab data was positive".

Rant and the PR edited:

Some useful information, but again, poorly executed PR & CC. NP boasting and bullcrap on top of lack of organization and missing focus and the objective- which is to get this drug to market for COVID- today! For gods sake hire some competent marketing professionals to help you stay focused. Cost ya about $5-10k a month. Incompetent Marketing will kill- CYDY would have had a EUA months ago with a C-Level Marketing Director to create the laser focus on value creation on COVID. Most scientists just don't get that Brand Assets are worth more than patents or data.

CREATE A SENSE OF URGENCY! FOCUS!

NP cannot stay on his own script and forgets the point: The objective of this PR & this CC is to stimulate participation in and completion of this trial-ASAP! AND GET THE DRUG TO MARKET. It is not educate the public about DSMC minutia, or what your fuzzy timelines are or what your doing about anything other than COVID. COVID. COVID.... COVID.

Its telling a story that people are desperate to hear: a potential solution to COVID. Period. COVID. (Oh, oh, but what about NASH, NASDQ, XYZ? "Dr. Lazri/Dr. Kelly/Dr. XYZ will have a NASH/NASDQ/XYZ update on or before November X. Next question please.")

CREATE URGENCY: Write a headline and run a CC with news a media outlet can use verbatim:

Primary Headline: "Excellent COVID-19 Interim Analysis on Mortality Prevention Study for Novel Monoclonal Antibody Drug: Leronlimab."

Secondary Headline : "300,000 Doses of Monoclonal Antibody Leronlimab in Stock with 800,000 more to ship based on Phase 2b/3 trial results"


(Vancouver, WA) Cytodyn, Inc., a small biotech company, announced today excellent Interim Results Analysis recommendations by the Data Safety Monitoring Committee (DSMC) on their lead product Leronlimab, a monoclonal antibody. The interim analysis was performed on data from the first 195 (50%) of 390 planned patients in a Double Blind Phase 2b/3 clinical trial.

Safety and efficacy data led the DSMC to recommend the trial continue without modification to achieve the primary endpoint of mortality reduction. The DSMC also requests another interim analysis when enrollment reaches 75% level, as patient mortality and other clinical outcome data may be sufficiently positive to conclude the study early.

Enrolment for Severe and Critical COVID-19 patients is currently available in 14 hospitals throughout the USA. Patients in the UK will soon be able to participate in this study at seven hospitals.

To meet potential COVID-19 demand Cytodyn has 300,000 doses of Leronlimab in stock now. Over 800,000 more doses are on order and in process in anticipation of potential FDA Emergency Use Authorization. Cytodyn is seeking approval for Leronlimab for patients in these most dire of circumstances, people that are severely and critically ill such as on a ventilator, with multiple organ damage or septic shock.

COVID-19 mortality has reached 220,000 U.S. citizens and authorities project this to reach 400,000 deaths by year end without treatment. Given that that the CDC states vaccines will not be widely available until the middle of 2021 potential treatments like Leronlimab are urgently needed.

ACCEPTED MANUSCRIPT
Clinical Characteristics and Outcomes of COVID-19 Patients Receiving Compassionate Use Leronlimab

Click on "PDF" at

https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1583/5932277

to read full paper...

deamon: what is a "make order"?

spot on

(Reuters) - U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly and Co pharmaceutical plant ...But the findings by the U.S. Food and Drug Administration inspectors at the Lilly manufacturing facility, which have not been disclosed previously, could complicate the drugmaker’s bid for a so-called emergency use authorization (EUA) from the federal agency, two of the sources and two outside legal experts told Reuters. That’s because U.S. law generally requires compliance with manufacturing standards for authorization of a drug.

https://www.reuters.com/article/us-health-coronavirus-lilly-exclusive/exclusive-fda-faults-quality-control-at-lilly-plant-making-trump-touted-covid-drug-idUSKBN26Y30C?il=0

Some folks in sourcing at Lily are having a bad day.

Take some action - submit comments on Cytodyn & Leronlimab and the challenges of small companies being heard.



The Reagan-Udall Foundation for the FDA Meeting has a call out for 3 minute public comment/speakers.  (I learned about this foundation from correspondence with the FDA.)

DUE  10/09/2020 at 5 PM EST

Public comments are strictly limited to three minutes per speaker. Comments should be submitted to Ngozi Amaechi via email at namaechi@reaganudall.org by 5 pm (eastern) on October 9, 2020. The email should include your written comments along with your name, affiliation, address, telephone number, and email address. You will be notified about your request to speak by October 12, 2020.  


https://reaganudall.org/news-and-events/annual-public-meeting/2020-annual-public-meeting

Also: You can look up comprehensive lists of COVID treatments under investigation here:
https://covid19.reaganudall.org/covid-listings

For newbies/review for us old gals/dudes that forget details:

Next week an announcement of interim evaluation of Leronlimab efficacy at the 50% mark is being made based on 195 patients in a Phase 2b/3 trial.


Official Title:
A Phase 2b/3, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)

Primary Outcome Measures:

All-cause mortality at Day 28 [ Time Frame: Day 28 ]
Day 0 refers to the data of randomization/first treatment.


Secondary Outcome Measures :
All-cause mortality at Day 14 [ Time Frame: Day 14 ]
Day 0 refers to the data of randomization/first treatment.

Change in clinical status of subject at Day 14 (on a 7 point ordinal scale) [ Time Frame: Day 14 ]
A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Change in clinical status of subject at Day 28 (on a 7 point ordinal scale) [ Time Frame: Day 28 ]
A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. [ Time Frame: Day 14 ]
The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine





https://www.clinicaltrials.gov/ct2/results?cond=Covid19&term=leronlimab&cntry=&state=&city=&dist=&Search=Search

Wrong. NP just spent $7.5M to acquire CYDY stock.

He just outright bought 500k shares.

He bought 2M shares by exercising option to BUY at $3.12

Nader Pourhassan just

1) Showed confidence in the company: NP bought 500,000 shares of CYDY 9/30/20 - which would show confidence in the company by investing $1.5M in CytoDyn. After taxes, that's his last 2 years salary.


2) Adding $6.24M to Balance Sheet, increasing CytoDyn's cash by exercising 2M options at $3.12

https://d1io3yog0oux5.cloudfront.net/sec/0001807094-20-000017/0001807094-20-000017.pdf

POTUS heading to hospital. Welcome to the reality of science.

Wear your d*mn masks. Wash your hands. Stay home and watch TV.

My bet on CYDY continues. Unlike betting on election:

https://www.cnn.com/2020/10/02/investing/uk-bookmakers-suspend-trump-bets/index.html

International Society for Influenza and other Respiratory Virus Diseases

Wednesday, October 7
15.35-15.50 GMT
(10.35-10.50 AM EST)

A Phase 2 Study of Leronlimab for Mild to Moderate Coronavirus
Disease 2019 (COVID-19)
- Harish Seethamraju, Montefiore Medical Center, Bronx, NY, USA

https://isirv.org/site/images/conferences/AVG_COVID_mtg/Programme%20%20-%20updated%2030%20September.pdf

E-Rabbit: Gotta agree. Accumulation is happening. I know cause I am adding a bit, cause, you know, I like BOGO sales. This thing is worth at least $6 by this time next year. Maybe its BOGT - buy one get two. We already saw $10, an easy valuation just on HIV. COVID is icing.

I'd bet we'd see $4 next week if NP & SK just announced they hired a Communications Director.

CM: Id like to add an edit :

1. Stop the trial you are unsafe < a) for all participants or b) because it is unethical to not be treating the placebo group >

My brain stopped working and I forget how many of the 70 or so compassionate* use pt died- I don't remember seeing anything after the April 30 PR notice. but looking at just the 23 pt in CA I am quite convinced that the fatalities in the LL arm of the S/C are low.

*Emergency Investigational New Drug (EIND) status by the FDA for use in COVID-19 patients.

"Twenty-three (23) patients in Southern California hospital: Six patients were in critical condition (intubated) and 17 patients were severely-ill, needing oxygen support. No death was reported. Out of 6 critical patients, all were intubated patients, 3 were extubated (taken off ventilator), 2 patients remain relatively stable and still breathing with the assistance of a ventilator and one patient has shown deterioration in respiratory parameters. Of 17 severe condition (but not critical) patients, 11 patients demonstrated improvement in respiratory parameters (8 of them were discharged from hospital, including one patient in the news, Samantha Mottet), 2 patients remain relatively stable, 2 have shown deterioration in respiratory parameters and information is pending for 2 recently treated patients."
https://www.cytodyn.com/newsroom/press-releases/detail/424/cytodyn-reports-strong-results-from-eind-covid-19-patients";

PS. IMHO tilted way in favor of wanting this COVID thing to be over and SP to be higher

presentation at :
https://d1io3yog0oux5.cloudfront.net/cytodyn/files/pages/cytodyn/db/256/content/CytoDyn+2020+Virtual+Annual+Meeting+of+Stockholders+%289-30-2020%2C+930amPT%29_To+website.pdf

Did not think I'd get the chance to buy more at $3! This sucks and is good.

Well, here we are again- another fantastic opportunity. In May, June, July, August, Sept: hitting a $3 range price. If your looking for a good entry point in this speculative stock, here it is.

ST Triggers:
09/30/20 SH Holder Matting
10/6-8-20 ISIVR - Virology Conference Presentation
10/15/20 - Data for 195 pt for S/C Phase 3 trial to FDA and MHRA
NADSQ: On approval thousands of vials become doses of inventory with qualification for NASDQ balance sheet requirement.

LT Triggers:
Multiple large market indications
No SAE's

PS. Ya, as a long it hurts to see these bounces. As a trader- wooppeee!

Whoever posted this- THANKS!

If your here, grab a drink or a cup of tea and listen... This is the MD with THE MOST experience with LL.

Excellent interview with Dr. Jacob Lalezari from Cytodyn and Quest Clinical Research. Long, but very informative if you want to learn something.
https://soundcloud.com/user-615722623/full-interview-with-dr-jacob-lalezari

Go to minute 46:
"We know leronlimab works in COVID-19"
"When we see CD12 we will know if its a Double, Triple or Home Run"

Nader: HIRE A COMMUNICATIONS DIRECTOR!!!!! You have so much good stuff and you keep failing to build trust with your audience.

Upcoming PR: NO NEWS IS GOOD NEWS UNTILL THERE IS NEWS.

This is the news I want from CYDY:
https://www.voicetube.com/videos/28367

Re: NASDQ Uplisting. CYDY is competing for attention at NSADQ offices with a lot of other companies. They apparently have a LOT of companies wanting to uplist. We are not the only shareholders waiting for management to execute... Proactive vid from CEO Evan Gappelberg (NEXCF) who is in the same position as NP... waiting and explaining to his shareholders after they applied in early July...

Rant for the DAY....

Don't forget CYDY has a PR event opportunity coming out next week DURING TRADING HOURS!!! Sept 30. 12.30PM EST

If I were the much needed COMMUNICATION DIRECTOR I would test every microphone, video connection and do a full run through 2 hours ahead.

I would hire an MC for the event (a TV or Theatre actor). And with a pleasant smile and a clear and well modulated voice, they would:

1) call on CFO to run the SH Meeting, present business at hand, open, vote, close meeting.

2) then call for a VERY SHORT NP speech with 4 slides about how amazing it is and how far we have come from last Sept and his vision of where will be next Sept. ( Last year he was really good at this. This NP speech is why I bot a LOT more, even tho it was like 33 cent and I was down 60%, and have stayed long. Clear, succinct, passionate, detailed. Not defensive AT ALL).

3) then they'd call on SK to provide a very nice welcoming introduction of the Scientific Advisory Board members.

4) Then would ask three of SAB members to speak for a few minutes to answer the question: "What is it about LL that excites you most?"

5) Then they would READ questions from Shareholders:
NO OPEN MIKE BULLCRAP
10 WRITTEN QUESTIONS SUBMITTED 24 HOURS IN ADVANCE
Then they would then read the questions and ask CEO, CFO or CMO to answer.

Preliminary Prorgamme for ISIRV Conf where LL M/M P2 will be presented does not show any of the Oral Abstracts ( yet!), but one key speaker:

ERICA OLLMANN SAPHIRE, PH.D. is presenting at the ISIRV Conference- Not a slouch in the virology area ( and she likely can kick your a$$ as she is nationally ranked rugby player)

"Monoclonal Antibodies"
Erica Saphire, La Jolla Institute for Immunology, CA, USA
https://drive.google.com/file/d/1ECGUNUm1Um6lYsICJGYCaGtPDkD40oli/view


LJI PROFESSOR ERICA OLLMANN SAPHIRE AWARDED $6.4 MILLION FOR INTERNATIONAL EFFORTS TO BEAT COVID-19
https://www.lji.org/news-events/news/post/lji-professor-erica-ollmann-saphire-awarded-6-4-million-for-international-efforts-to-beat-covid-19/

(Caps are not mine- from cut & paste)

Onion: Dude, ya gotta pitch in, just a couple mil, the CYDY race team, we need ya. It'll only be a 23 minute flight from PDX once we put the airstrip in. Tell ya what, I'll ill go in on this tropical if you join us in the race track
https://www.zillow.com/homedetails/9-Bay-Dr-Lahaina-HI-96761/2088332790_zpid/.

All: Per ZZ Top: The Future is so bright I gotta wear shades. LL indications will roll out when they roll out. Either the science is true or its not. NP is an AWFUL communicator, and has lead to banker mistrust, major delays and flat-out disbelief by many. BUT he has gotten this thing from $120M to $2B while I've been watching- one tenacious bstrd. AND, if a BP offered $21B Monday in a hostile, I'd take it in a second.

Fingers crossed on COVID Rx mid-October data release of 195 pt. in S/C trial. (count on at least 3 weeks for data security/gathering/analysis and sign-offs.) Would relieve a lot of suffering and the deeper economic damage we will have as vaccines will not be US public ready till Q3 at best. So, as I have said before: GO HELP GET PTS for S/C-P3- less than 180 needed!

Anyone want to go in on this place when CYDY hits $50?
https://www.loopnet.com/Listing/93811-Blagg-Ln-Grass-Valley-OR/17919063/

Can someone provide a coherent description of this company with some externally verifiable data sources?

I don't think its reasonable, no. CYDY stated the schedule based on the fact that there are multiple institutions involved and maintaining study integrity (double blinding) is FAR more important than getting a fast interim answer. Don't want to have to start over again cause your data was compromised.

It's called "Pay to Play". BP can pay.

DCA: He could be referencing Lysol or Clorox, as he has in the past suggested these be investigated. Maybe they skipped to secret P3 trials and have good news.

Nice find Bio

Totally stoked for the Hamsters! Or LL could save thousands of hamsters, perhaps mice, too!

Johnson & Johnson (JNJ.N) said on Thursday its experimental coronavirus vaccine prevented hamsters from getting severely ill, as the drugmaker seeks to begin large, late-stage studies in humans later this month.

https://www.reuters.com/article/us-health-coronavirus-johnson-johnson/jjs-coronavirus-vaccine-candidate-prevents-severe-disease-in-hamsters-idUSKBN25U2UA

And, someone just sold 500k shares.

Quick rant for the day: CYDY is a small biotech with little political juice, limited communications skills and a management style that is different, but has a great multi-indication product, great opportunity and crazy-tenacious CEO and BOD.

1. Financial. A great buy opportunity, still. I am here as I think this thing has a good shot at $10 in 6 mos and $20 in 12 months. Risk? Absolutely. But 25+ indications and some interesting science- worth a shot. (then again, TSLA)

2. WH knows of LL for COVID: P2 M2M study hospitals included Novant in NC. Who is the WH-COS? Meadows is human, has kids, parents, friends, partners at risk. There are WH eyes on LL. Sure the Biden crew is aware as well.

3. OWS is nearly 100% focused on VAX. Big barriers to entry for small companies; vax focus, grant resource management and regulatory requirements are prohibitive. Big Pharma gets access cause this is win at all cost thing and BP & US Gov is playing hard. They have proven their excellence in science, finance, marketing and management - these folks are far smart, tough and proven. OWS door is open to CYDY- just not on the need-to-do list today.

4. Treatment is needed no matter what. The hope for a vaccination by 12/31/20 seems far fetched and for US implementation by this time next year - meh, I have serious doubts. I just don't see how FDA is going to clear safety. I am skeptical of "accelerated science". Vax development is a huge crap shoot to begin with. Participation is huge issue: 45% vax rates for the normal flu. https://www.cdc.gov/flu/fluvaxview/coverage-1819estimates.htm I get flu, tetnus, shingles and my kids the full series, but apparently a lot of folks don't.

5. WSJ coverage- excellent! Just that it is happening! Eyes on! More reporters and editors now have validation that CYDY has potential. And real journalists now have permission to dig into this Cinderella Phase 3 S/C COVID story, to spend time on the opportunity to dig into CCR5, Rantes, cytokine MOA and maybe, just maybe, see this treatment coming out of "left field".

CYDY still up over 10x since December. The hypothesis for this investment is still true: HIV, NASH, GVHD and multiple cancer. COVID has always been an added bonus. Nice day for $3.10 buy! Thanks!

Nice synopsis of the current state of affairs on the biomed/virology MOA for Leronlimb... well done.