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***OFFICIAL CYDY/Leronlimab Thread*** (2 Viewers)

Whyatt said:
I’m going to need to read this. If RANTES isn’t elevated in severe, isn’t that a gap in the COVID is a RANTES disease and it will work for severe?

 I’m not a virologist, my question is naive. Has this question been asked/answered  by Dr. Patterson?
Click to expand...
No idea if Patterson has seen this study. It is interesting for sure. At the very least another group has confirmed RANTES elevation is seen in mild to moderate. 

 
I was just reading about Remdesevir and the  trials.  They actually changed the primary endpoint well into the study for it to be days in the hospital.  I don't believe they would have passed the original primary endpoint.

 
Chaz McNulty said:
I was just reading about Remdesevir and the  trials.  They actually changed the primary endpoint well into the study for it to be days in the hospital.  I don't believe they would have passed the original primary endpoint.
Click to expand...
That's why they changed it. But hey, FOUR fewer days in the hospital to go with your organ damage. Woo-hoo!

 
from the CYDY Facebook group

Jeff Iorio

Cytodyn Shareholders Community

ctSpolnsorced6h

  · 

I want to let the group here know that I emailed Nader urging him to enlist a top-flight communications firm to handle upcoming press releases, especially regarding efficacy data. He replied:

"Thank you. I will take all you said very seriously and work on all of them. You are right. Thank you

With best regards

Nader

 
cosjobs said:
from the CYDY Facebook group

Jeff Iorio

Cytodyn Shareholders Community

ctSpolnsorced6h

  · 

I want to let the group here know that I emailed Nader urging him to enlist a top-flight communications firm to handle upcoming press releases, especially regarding efficacy data. He replied:

"Thank you. I will take all you said very seriously and work on all of them. You are right. Thank you

With best regards

Nader
Click to expand...
That was nice of him to respond to @fantasycurse42.

 
cosjobs said:
from the CYDY Facebook group

Jeff Iorio

Cytodyn Shareholders Community

ctSpolnsorced6h

  · 

I want to let the group here know that I emailed Nader urging him to enlist a top-flight communications firm to handle upcoming press releases, especially regarding efficacy data. He replied:

"Thank you. I will take all you said very seriously and work on all of them. You are right. Thank you

With best regards

Nader
Click to expand...
Seems someone should be proofing his emails too. Sorry, couldn't help myself.

 
So while it appears the M/M data will take some time to interpret wasn’t it expected to get the serious trial interims this week? 

 
The concept of "better therapeutics" is on the rise, whereas the vaccine story seems to be waning. Gates just said as much on CNN (regarding therapeutics). Now is the time. 

 
fantasycurse42 said:
A transaction between a seller and some buyers.
Click to expand...
Is there some distinction to be made when a single very short period of time has a spike in volume of about 20% of the entire trading day and results in significant decrease in share price?  Is there really no good name for this type of activity?

If you have 500k shares you want to sell, odds are you want to get the best price so obviously dumping them all in the middle of a low volume day all at once isn’t going to work well for you, So it seems the purpose of such a sale is not to get top dollar for the sale.  It’s why I assume the true purpose is to drive the price down, calling it a short attack (may not be the right name).  But surely it’s a tactic that is not just normal buying and selling.

in this case in a day where to that point in the day only about 2.5 million shares were traded, in a period of a minute 500,000 shares were traded at once moving the share price down about 4% nearly instantly.  
 

lots more knowledgeable people around than me so happy to be corrected, but at least from my perspective it seemed like a short move.

 
Otis said:
next week will be the big one!  Next week...
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2 weeks, it’s going to be big and beautiful. Everyone is saying this.  Lots of people tell me this.  2 weeks and beautiful.  
 

*sorry couldn’t resist the low hanging fruit.  

 
⚡DEADHEAD⚡ said:
The concept of "better therapeutics" is on the rise, whereas the vaccine story seems to be waning. Gates just said as much on CNN (regarding therapeutics). Now is the time. 
Click to expand...
This has been pretty obvious for quite some time.  Vaccines take a LOT of time, not to mention for something like COVID will be tricky.  A vaccine very well may only put a dent in the problem depending on how well it works and who is even willing to use it.  

 
From the Yahoo Message Board:

MOD (Arian Colachis, General Counsel and Corporate Secretary)
This concludes the formal business at the stockholder meeting, and the meeting is now adjourned. It is now my pleasure to turn today’s meeting over to Dr. Pourhassan, our President and CEO, who will provide a brief overview of our business and future direction.

[Question instructions]

Dr. Pourhassan, the floor is now yours.

(6:20 into the meeting)
NP
Thank you, Arian. Thank you, everyone, for joining us in this Special Stockholders Meeting.

Before I start today’s update I must say I recently have been receiving many kind emails from our shareholders. And I want to read you one that was sent to me last night that I appreciated very much. The email says, “Dr. Pourhassen: Congratulations on the good news today. I believe in CYDY and Leronlimab, and I wanted to encourage you to continue fighting with all you have for the patients who are counting on you. They don’t have a voice, but you can be their voice. Please don’t get weary or tired. God bless you.”

Please note and rest assured that I am, and my whole team at Cytodyn is, very energized. We are energized more than ever, and we will not stop working very hard until we explore every avenue and every indication for Leronlimab’s potential to help mankind. We are honored to serve you, the shareholders, and I thank you for giving us this opportunity.

We at Cytodyn believe we are very close to be able to submit some solid data from our therapy for COVID-19 to the FDA for consideration for final approval in two separate populations: mild to moderate and critical and severe. We will stay visible, transparent, and we will report honestly everything that happens in our company as frequently as possible, like usual.

So allow me to update you in regard to recent activities. First, and most important, two COVID-19 trials. We start with CD-10, the mild and moderate population. As we all know, we have unblinded the data on our Phase 2 COVID-19 mild to moderate population as Cytodyn announced yesterday the data in regard to the safety of the trials, and will be announcing the efficacy as soon as the statistical analysis of all the exploratory endpoints are evaluated.

So in regard to yesterday’s news about the safety of Leronlimab in COVID-19 trials: Usually in any clinical trial if the final result demonstrates that the two arms of the study, the placebo and the drug, have the same number of serious adverse events, same number, then you have a fantastic result in regards to how safe the drug is. However, we already know Leronlimab’s safety with hardly any SAEs in over 900 patients and so forth, right?

(10 minutes into the meeting)
So what is the significance of having almost 3 times more SAE’s in placebo as compared to Leronlimab arm in this study? Leronlimab is probably the only drug in the world right now that just announced that taking Leronlimab for mild to moderate COVID-19 can lower the risk of having an SAE that could be life-threatening by 64%. We believe this is amazing achievement.

In this population of mild to moderate COVID-19, almost all patients recover fine. Therefore the most urgent matter would be how many life-threatening adverse events you could potentially have that would make your life miserable while you recover, right? Leronlimab demonstrated in CD-10 study that it can lower than possibility by 64%. In the words of Dr. Jay Lalezari, this should be the efficacy for this population.

But allow me to let our Chief Medical Officer, who’s also Chairman of our Board, very close friend of mine, Dr. Scott Kelly. Dr. Scott Kelly could you please elaborate on this result that we just announced yesterday and its scientific significance please.

SK
Yes, thank you, Nader. COVID-19 is a very complex disease and we’re using Leronlimab to leverage the immune system to fight the virus, the restoration of the CD8 population, calm the cytokine storm, and prevent immune exhaustion through immune trafficking. This is a very complicated process without room for error. If the immune system is not orchestrated perfectly, then it has potential to show up as serious adverse events.

When you look at some of the other drugs that were used in an attempt to modulate the immune system for COVID-19, for example, recent IL-6 inhibitors, the SAEs worsened in the treated group vs. placebo. For Leronlimab to show a 64% reduction in serious adverse events is remarkable, and we believe will ultimately translate into improved patient clinical outcomes.

This also provides us with further confidence in the ability of Leronlimab to play a safe role in the orchestration of immune trafficking in the tumor microenvironment for oncology indications. Many of the traditional treatments in oncology are burdened with serious adverse events, and we believe that if Leronlimab proves effective in oncology, it will be a welcome addition to physicians’ treatment options. Nader.

Re CD-10, m2m:
-- So we can’t wait to put out the efficacy results as soon as the statistical team at Amarex completes that work.
-- As soon as we have the topline report we will send to the FDA the whole package and request emergency approval for this indication based on unmet medical need.

-- In regards to our CD-12 study, the process of approval could be even easier, as this study is a registrational study, a Phase 3 study, and FDA has agreed with us that this study could lead to approval, should the results be strong.
-- We will have the Data Safety Monitoring Committee, DSMC, take a look at the safety of the first 100 patients who have already completed the full course of the trial, which is 4 weeks. This is not an Interim Analysis, but is simply a safety look at the data by DSMC.

NP
So allow me now to update you on our cancer trials. All the cancer trials, 23 different cancer trials. A trial called basket trial, which most people don’t have, one of the few companies who has basket trial, 22 different cancers and [inaudible].

(16 minutes into the meeting)
We are planning to meet with the FDA in September for Breakthrough Designation discussions, as we believe we should have enough data to make a case for Breakthrough Designation. I don’t know if everyone remembers. Because of the pandemic everybody probably forgot. We have potential for Breakthrough Designation in 23 different cancers.

We currently have 6 patients enrolled in our basket trial, with 5 pending eligibility for a total of potentially 11 patients. In the [inaudible] main trial and compassionate we have 15 patients, and 12 are pending eligibility, for a total of potentially 27 patients.

(17 minutes into the meeting)
So I am going to ask Dr. Scott Kelly again to elaborate on mechanism of action of Leronlimab that allows this kind of indication to be potential. Is this real, is this dream, is this a miracle? What is it? Dr. Kelly, please tell us.

SK
Yes, Nader. Thank you. So COVID-19 has been a great teacher for us in regards to Leronlimab, and we believe that the safety in COVID-19 will translate into Leronlimab’s use in the tumor microenvironment. In cancer, we work by controlling the tumor microenvironment by limiting T-reg infiltration, which shuts down the anti-tumor response; conversion of pro-tumor M-2 macrophages into anti-tumor M-1 macrophages; limiting angiogenesis that enables tumor growth; and controlling CCR5 tumor over-expression, which has been shown to correlate with poor patient clinical outcomes. All of this is supported by independent research and CCR5 antagonism independent of Cytodyn. Nader.

(18 minutes into the meeting)
NP
Thank you, Scott. Now I would like to talk about the BLA submission. Lots of excitement among the
shorts reports that usually a bunch of lies and deceit that Leronlimab is not real. Well, I can tell everyone GSK, ViiV, spent over 400 million, about 400 million, on the injectable for 5 to 10 years almost. And the last day before they get approval, or last two weeks before they get approval, they get a complete response letter saying “rejected.”

Itolizumab, another antibody similar to us for HIV, had the PDUFA date and right before getting approval they got a 6-month delay because of manufacturing that was done in China, and they had a long list of items that they had to correct, which took them 6 months delay.

We have no issues with our manufacturing so far for it to have enough information to have review. We had some issues with our clinical section, which we believe we can resolve them. But in regard to BLA, we are requesting a Type A meeting, most likely next week, and after meeting with FDA we will give the shareholders timeline for new BLA submission and potential date for PDUFA. Because of all these trials and different indications that this product has, and we are just a little OTC company who just becoming $3 billion market cap size.

(20 minutes into the meeting)
So now I want to let you know that I have asked Dr. Scott Kelly, our Chief Medical Officer, to put together a list of top key opinion leaders who could get very excited about the mechanism of action of Leonlimab because top scientists when they see Leronlimab, it’s different than people who have no science background. They get very, very excited. In the words of one of the professors at [inaudible], I won’t give you his name, said that, “When the results that I got from Leromlimab I presented at the NIH meeting, everybody’s eyes just got wide open. They said, ‘Are you kidding? What is this product?’ “

This is the experience we had. Dr. Denis Burger, [inaudible] study, he had tears in his eyes when he represented it to the Board. He said, “This is amazing.”

Now, I have asked Dr. Scott Kelly to get hold of top-tier opinion leaders to form a powerful Scientific Advisory Board to help us with what -- not drug discovery. We discovered Leronlimab 25 years ago, Dr. Paul Maddon and William Olson did that. To help us to fine tune our protocol, to help us with the top experts that we have at Amarex who have done spectacular for us, to maneuver the path that we have to go through to get to approval for each and every one of these indications. With that, Dr. Kelly, could you update the shareholders where we are with that

(21 minutes into the meeting)
SK
Yes, Nader. Thank you. In regards to the Scientific Board of Advisers, we have made significant progress. I would like to share with you some recent additions to our Scientific Board of Advisors. In HIV I’ll begin with Dr. Gero Hütter, best known for his achievement of being the first doctor
to functionally cure HIV through an innovative procedure. His patient, Timothy Brown, also known as “the Berlin patient,” is considered to be the first person cured of HIV. Dr. Hütter was instrumental in recognizing the importance of CCR5 receptor in HIV cure, and will be a vital asset to Cytodyn’s Scientific Board of Advisers.

In oncology, Dr. Hope Rugo, who is Professor of Medicine in the Division of Hematology and Oncology at UCSF, where she is the Director of Breast Oncology and Clinical Trials Education.
She has experience in malignant hematology, bone marrow transplantation, with a strong interest in novel target therapies and immunotherapies for early- and late-stage breast cancer. She is widely published and highly regarded in the field of oncology.

Dr. Lish Ndhlovu. he is Professor of Immunology at Cornell, Division of Infectious Diseases. His interests include HIV, immunology, HIV and aging, and he has a strong interest in cognitive impairment and Alzheimer’s.

Dr. Eric Mininberg. Dr. Mininberg graduated from Dartmouth and University of Virginia medical school, completed his hematology fellowship at Baylor and his medical oncology fellowship at M.D. Anderson. He will be helping us with clinical trial enrollment in the Southeast region, and further exploration of indications in oncology.

Dr. Jonah Sacha. Dr. Sacha has a Ph.D. in molecular microbiology and immunology. Dr. Sacha will be helping us with our HIV cure and PrEP program.

We also have commitments for physicians in the fields of pulmonary and lung transplant, two hepatologists with an emphasis on fatty liver disease and NASH, a physician who specializes in bone marrow transplant and blood cancers, among others. We will be announcing the remaining members of the Scientific Advisory Board in the coming weeks. Thank you.

(27 minutes into the meeting)
But with that, we would like to uplist to NASDAQ. Mike Mulholland and his team have worked tirelessly. The other day I went to the office and I asked our Controller, Antonio, “Where is Mike, it’s already 8:30 in the morning?” He said, “He’s late.” I said, ‘Why?” He said, “He went home two hours ago.” So this is the kind of work we’ve been doing at Cytodyn.

MM
Thanks, Nader. Exciting time for the company. Good morning. Quick update on the NASDAQ application and review process. Think of it in terms of about a 5 to 6 week process. Last week was week #1, we are now well into week 2. Next week, week 3, we expect to receive a comment letter from the NASDAQ uplisting staff. Our team will assemble and respond promptly to any additional follow-on questions they have. And so as we look ahead, week 5 on the continuum, it’s about mid-August. And at the outside, week 6 is about the third week in August. One final note is one of the last pieces to this process will be the filing of the company’s 10-K, which is due to the SEC not later than August 14. And we are working very hard to file early so that this all comes together at the same time. Nader.

NP
So I have a question that just came in. Can they hear us? Can everybody hear us right now? So the question is, “Can you please talk about the registered CD-12 -- the registration of CD-12 trial -- and the differences of that compared to your mild to moderate trial?” Yes we can.

The mild to moderate trial is a Phase 2 that explores many different endpoints: time to get ventilation, time off ventilation. And then the main primary endpoint, which we call a primary endpoint, but in Phase 2 there is not a set primary endpoint because phase 2 is a discovery, discovering what you have, what your product can do. So you look at 11 different, perhaps, items and you say, “Hey. 5 of these we can work on. So then you do a Phase 3 and pin down those points. But in pandemic or when you have unmet medical need, you can look at those, say there is a clear difference, for example, in getting better, the time to getting better like Remdesivir had 11 days vs. 15 days time to discharge. So if you have that, then you would go to FDA and have discussions.

We believe because it is an unmet medical need and there is nothing out there that can do what Leronlimab does and has done in the emergency IND patients, we go to the FDA and request for approval. That’s CD-10, that’s mild to moderate. So there’s work to be done here.

With CD-12, that’s not the case. CD-12 is a registrational trial for approval with a simple primary endpoint: number of mortality. Now, we have had serious adverse events reported to us, so we know there are quite a bit of deaths unfortunately in this trial. And when we unblind it, we get to see the difference. A safety look at the data would allow the Data Safety Monitoring Committee only to get unblinded and look at the data and report to FDA it’s safe to continue and go forward.

The Interim Analysis would give you complete analysis of the data until the point that you do Interim Analysis. You send that to FDA and make a case that we should get approved now and not to continue.
Click to expand...

 
Last edited by a moderator:
"Before I start today’s update I must say I recently have been receiving many kind emails from our shareholders. And I want to read you one that was sent to me last night that I appreciated very much. The email says, “Dr. Pourhassen: Congratulations on the good news today. I believe in CYDY and Leronlimab, and I wanted to encourage you to continue fighting with all you have for the patients who are counting on you. They don’t have a voice, but you can be their voice. Please don’t get weary or tired. God bless you.”

Please note and rest assured that I am, and my whole team at Cytodyn is, very energized. We are energized more than ever, and we will not stop working very hard until we explore every avenue and every indication for Leronlimab’s potential to help mankind. We are honored to serve you, the shareholders, and I thank you for giving us this opportunity."

This is possibly the most ridiculous thing i've ever heard from a "shareholders" meeting.

 
Nader Trump: 

I get very many emails. Many emails. You wouldn’t believe it, takes up my whole desk. And they all say, sir,  Congratulations on the good news today. The best news. They’re in shock. They all believe in CYDY and Leronlimab, all these emails, very many of them and they wanted to encourage me to continue fighting with all I have for the patients who are counting on me. And they’re all counting on me. Me. And I say thank you. They say that they don’t have a voice, but that I can be their voice. And I am. God bless you and God bless cydy and God bless America.

 
Last edited by a moderator:
ILUVBEER99 said:
"Before I start today’s update I must say I recently have been receiving many kind emails from our shareholders. And I want to read you one that was sent to me last night that I appreciated very much. The email says, “Dr. Pourhassen: Congratulations on the good news today. I believe in CYDY and Leronlimab, and I wanted to encourage you to continue fighting with all you have for the patients who are counting on you. They don’t have a voice, but you can be their voice. Please don’t get weary or tired. God bless you.”

Please note and rest assured that I am, and my whole team at Cytodyn is, very energized. We are energized more than ever, and we will not stop working very hard until we explore every avenue and every indication for Leronlimab’s potential to help mankind. We are honored to serve you, the shareholders, and I thank you for giving us this opportunity."

This is possibly the most ridiculous thing i've ever heard from a "shareholders" meeting.
Click to expand...
Ok I’m being serious here...Do you attend a lot of them?  Is it ridiculous to be mission driven and highlight that through an anecdote like that?  

 
Don Hutson said:
From the Yahoo Message Board:
Click to expand...
Impressive list of Advisory Board Members. All can provide advise and guidance to LL application for different indications. One step forward toeach one back. But its more like 3 steps forward for each 2 back. Continuing to inch forward on an uphill climb.

 
Moonlight said:
Impressive list of Advisory Board Members. All can provide advise and guidance to LL application for different indications. One step forward toeach one back. But its more like 3 steps forward for each 2 back. Continuing to inch forward on an uphill climb.
Click to expand...
How about a press release introducing the new board members?

 
Whyatt said:
https://clinicaltrials.gov/ct2/show/NCT04475991?cond=covid-19&cntry=MX&draw=2&rank=5

A very interesting development, a Maraviroc (CCR5 Antagonist) phase 2 clinical trial is being initiated in Mexico. The fact that this drug hadn’t been looked at to date was probably my biggest red flag for Leronlimab. 

On the other hand, this might be why the Leronlimab Mexico trial hasn’t gotten anywhere.
Click to expand...
Thabks for this. It’s just being initiated so CYDY is a good 6 months ahead of the game, right? Also, is it at all concerning that it’s not a blind study? Those two things jumped out to me. 

 
Whyatt said:
https://clinicaltrials.gov/ct2/show/NCT04475991?cond=covid-19&cntry=MX&draw=2&rank=5

A very interesting development, a Maraviroc (CCR5 Antagonist) phase 2 clinical trial is being initiated in Mexico. The fact that this drug hadn’t been looked at to date was probably my biggest red flag for Leronlimab. 

On the other hand, this might be why the Leronlimab Mexico trial hasn’t gotten anywhere.
Click to expand...
Cydy is a pump and dump.  Them being in Mexico didn't matter.  But being competed with in Mexico does.

Just as bad as everything's a short attack.  

 
General Malaise said:
adonis said:
Happy to learn.  What would you call it? 
Click to expand...
Are they borrowing the shares to short it?  No borrow available in this thing. 
Click to expand...
https://www.otcshortreport.com/company/CYDY
Is this reliable? Shows that yesterday over half the volume of trades were shorts.  Am I reading this wrong?

And just to be clear, I’m not calling any drop in price a short attack.  But when such a huge volume comes out of nowhere and pushes the price lower and immediately bounces back...It certainly has all the hallmarks of what a significant short trade would look like, no?

the example above had a volume for hours before and hours after in the low tens of thousands per unit of time.  During one minute range, the volume was 50X or more than normal and the price dropped fast and quickly recovered.  
 

So again, educate me, why doesn’t this look like a short attack where someone borrows a large number of shares, hits the stock at low volume, drives price down 4% and buys back on way up at less than sale price?  Looking at this example, why is such a conclusion likely wrong?

 
Pretend a whale has a lot of shares, in example someone like Chet owns 1mm shares, he has a cost basis of $1 and the price is $5.20. Chet is still bullish but looking to take a little risk off, so he decides he wants to recoup his initial investment of $1mm. With a ticker only trading 7-8mm a day, it will be difficult for him to put a limit order in for his 200k shares where the current price is, so he may put a limit order in to sell any shares at say 10-20 cents below the current ask (all the way down to $5). The price moves down and some buyers who were waiting now take advantage 10-20 cents below, driving the price back up.

It can work the same way if someone like that was looking to increase shares.

 
Jayrok said:
10 best and worst performing biotechs amid Covid-19

We may complain about price movement and many times lack thereof, but for some perspective CYDY is 2nd best with 449% change YTD.
Click to expand...
Hey, I own another on that list Crispr and I’m up double that because I waited to buy it until March.

Back when we were bouncing in the 2-3 range, I would have been psyched to see $5.70. Funny how the run up to $10 changed things because it got people in at a way higher cost basis and makes you feel like you lost half your stash.

 
Whyatt said:
https://clinicaltrials.gov/ct2/show/NCT04475991?cond=covid-19&cntry=MX&draw=2&rank=5

A very interesting development, a Maraviroc (CCR5 Antagonist) phase 2 clinical trial is being initiated in Mexico. The fact that this drug hadn’t been looked at to date was probably my biggest red flag for Leronlimab. 

On the other hand, this might be why the Leronlimab Mexico trial hasn’t gotten anywhere.
Click to expand...
Aren’t side effects worse for Maraviroc? This is a small molecule CCR5 while Leronlimab is a large molecule CCR5, what would key differences be?

Also, I’ve asked this a few times, some of your bearishness here has to be NP, no? I can imagine people in the medical field not liking him, making it more about the messenger than the product.

Regardless, therapeutics for Covid are going to be a huge business in itself (and there could be other indications too, such as triple negative breast cancer amongst others). They’ve demonstrated safety, if we see efficacy for Covid better than the current standard of care, the risk for a price explosion is severe, IMO.

 
Whyatt said:
https://clinicaltrials.gov/ct2/show/NCT04475991?cond=covid-19&cntry=MX&draw=2&rank=5

A very interesting development, a Maraviroc (CCR5 Antagonist) phase 2 clinical trial is being initiated in Mexico. The fact that this drug hadn’t been looked at to date was probably my biggest red flag for Leronlimab. 

On the other hand, this might be why the Leronlimab Mexico trial hasn’t gotten anywhere.
Click to expand...
Thanks.  It is interesting.  Maraviroc tablets are being used with (+) standard therapy of the hospital (Hydroxychleorquine or chloroquine, with or without other antibiotics) in one arm.

Another arm is Favipiravir + ST.  

Another arm is just ST. 

Last arm is Maraviroc tablets and Favipiravir + ST.  A cocktail of stuff. 

There is no arm with just Maraviroc vs a placebo.  

Estimated primary completion date:  December 2020.  There will likely be multiple therapeutic drugs in use for covid treatment by then.  

 
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