Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Misiu, when you say that "efficacy in combo with 350 mg is 81% at 25 weeks,
in monotherapy after 10 weeks on 700 mg, over 90%", does that mean that the reduction in viral load is 81% for 350mg and over 90% for 700mg or do those percentages refer to the amount of patients that respond to the treatment?
So what is the collateral?
I'm very interested.
RLFTF's doctor did a Youtube interview with Dr Yo and said that they had just enrolled their 104th patient in their covid trial, they need 144 total, which means their enrollment has really slowed down in the last month and a half. 104 is what they need for interim analysis so it will take 28 days to get to that and it seems like there is no way they get an EUA off interim with only 104 patients. They are looking at well into Nov or more likely Dec to finish their trial. Most investors thought their trial would be finished within weeks so this was surprising bad news.
Cytodyn just had an investors call and every time the CEO talks the stock drops.
If I'm wrong I'll be very happy but Cytodyn's drug leronlimab has an excellent safety record also in large HIV trials.
I still think the most likely scenario is the FDA will wait for the results of the trial, which should happen soon. I'm looking forward to hearing what Dr Javitt says tomorrow.
I know but I still don't think we'll see an EUA until the trial results are in. With Cytodyn they had good results from a double blinded placebo mild to moderate trial but the FDA said they had to wait for the results from their severe trial to get an EUA. Our expanded access was not blinded and didn't have a placebo so it seems very likely the FDA will wait for the trial results.
Pretty sure there won't be an EUA until the FDA gets the results of the trial.
First we'll see a press release that the trial has finished and it will give us the topline results. Then it will be up to the FDA to make the decision.
RLFTF's drug gets public praise from DSMC member.
I have a small position in RLFTF so I follow their news and this is very interesting. A congressman, who is a physician, is a member of their independent data monitoring committee and was interviewed by a local Fox Baltimore station. He had a very positive outlook on their drug RLF-100/Aviptadil which is big because he has seen the data from the study in their interim analysis, which was probably done in late August.
They only have 144 patients in their trial for patients with respiratory failure compared to our 390. With the small size, there was no way they were going to be stopped early at the interim but it sounds like the results will be very good, as the results of their expanded access program were. Their final results are expected maybe within the next couple of weeks.
As an investment RLFTF's biggest downside is it's 2.5B outstanding shares but the drug looks like it's going to be a winner with COVID. Their doctor will be on Dr Yo tomorrrow.
link to interview. It says vaccine but that's a mistake.
https://foxbaltimore.com/morning/congressman-andy-harris-overseeing-covid-19-vaccine-trial
Cytodyn fired Red Chip last spring because they were awful at doing their job promoting the company.
It was listed as closed at least as far back as the 17th
Here is a cached page from the 17th:
https://webcache.googleusercontent.com/search?q=cache:db7xhMNvoe4J:https://www.centerwatch.com/clinical-trials/listings/245622/intravenous-aviptadil-for-critical-covid-19-with-respiratory-failure/+&cd=1&hl=en&ct=clnk&gl=us
The 51 patients are the 21 in the RLF-100 group plus the other 30 receiving standard of care, so it's nothing new.
The problem is funding.
There is still something like $30 million due to Samsung by the end of Jan and the NASH and cancer trials have to be paid for. Nader mentioned an investment bank in the CC last week and he keeps saying he's going to wait for a much higher share price to issue new shares (and if he issues them lower than 10 bucks Iliad get theirs at the issued price) so we'll see how that all works out. The company is going to be in quite a financial pickle if the CD12 interim doesn't blow away the monitoring committee and lead to a quick EUA.
The interim data is probably not going to be released next week or anytime soon.
There is an independent committee that looks at the data periodically, Cytodyn can't see it only the committee can. They looked at it once already for safety and deemed the trial safe.
They will look at it again for efficacy and could stop the trial and give Cytodyn the results because the efficacy is extremely good but this is only happens rarely and Nader said yesterday not to count on it.
The only way we get data in the next weeks is if Cytodyn decides to take a big gamble and stop the trial early to see the results themselves.
If you are going to buy for SC I'd go with RLFTF instead as a hedge.
They should have their results sooner and their drug looks like it is as close to a slam dunk as possible for Covid.
The downside is that they have a massive number of outstanding shares and don't have real upside beyond Covid but if you are thinking about buying more CYDY just for SC then I'd go with RLFTF instead. It's what I've been doing anyway and I'm long CYDY and have been for almost 2 years.
He said they are working on a deal with an investment bank but who knows. He has been steadfast about not issuing new shares until the price goes up. That's why he has done the deals with Iliad.
But the big issue from the call is that he lied about requesting an EUA from the FDA. In a conference call and in a press release in early August it was stated that an EUA had been requested. Today he said no EUA was submitted or even asked for. Shareholders are livid.
For those who are interested in CYDY they just had the worst conference call in history and it was totally unnecessary. All they had to do was stay quiet but the impulsive CEO couldn't help himself. The only news was that there was no chance they were ever going to get an emergency use for their trial on moderately ill covid patients, the trial they had crowed about, but for some reason nobody at the company figured that out so they went to the fda and got shot down. The fda wouldn't even take a submission of the data.
Then the CEO for some reason got really angry with a guy asking an obvious and vanilla question about a date for enrollment in the UK. During the rest of the call he sounded really bummed out. He talked about multiple failures when he usually pumps for all he's worth. He's cracking under the pressure. Expect a bloodbath tomorrow with major selling and shorting.
I sold my HGEN a month ago because everything pointed to Cytodyn being in the lead when it comes to getting results out first but I'm rethinking that decision.
So it's not one market maker selling to another.
How were there that many shares available for purchase?
That's what I don't understand. Were there 1.5 million shares in open sell orders lingering out there somewhere?
HGEN drop could be exacerbated by shares being sold from a private placement a few months ago.
Here are the requirements for NASDAQ uplisting under the NASDAQ Capital Markets tier, which seems like the obvious tier for us.
It looks like we meet all the requirements if we have net tangible assets of $2 million and 3 market makers. The $3 closing price footnote says:
Yeah RLFTF is dropping also
CYDY is barely holding on due to it's results PR'ed yesterday but it's very, very weak FOMO going into the conference call this afternoon.
All of this comes down to how big of a threat the virus is still perceived to be going forward and the sentiment around vaccine timelines.
I have no doubt that unfortunately we will see things worsen as the weather gets colder which will lift the covid stocks again.
It's true. The CEO Nader's antics really get the adrenaline pumping, in both exuberant and frightening ways, so it makes you way more emotionally invested. Plus you spend months or years hanging on to every confusing or contradicting statement he makes, analyzing them to the nth degree.
He did a Proactive Investors video Friday that may be the last straw for me. It was like a TV evangelist having a manic episode. I've sold enough CYDY to cover my costs and make a nice profit so I'm good with my investment no matter what happens but I do have a whole lot of shares left and am seriously contemplating selling a bunch and putting the money elsewhere. I will be adding a little more HGEN next week to get to a nice round 10K shares. As I've written before I almost got in to HGEN a year ago when it was dirt cheap but was talked out of it by a doctor heavily invested in CYDY.
There is a caveat in that article.
We don't have a flashy CEO. On balance that's a good thing but it does affect how much attention we get.
I have 47 posts total, most on CYDY but that's not the only OTC I own so I've posted on a couple of other boards also.
I've been watching HGEN for a year and unfortunately was talked out of it earlier by a doctor who is invested in CYDY, I didn't know how biased she was when she gave me that advice. So my HGEN basis is about $4 and I'm concerned holding long term because of the amount of new shares authorized. As I said, if they are authorized I consider them issued. Just being as conservative as I can in a very risky space.
If the shares are authorized I consider them issued.
Just my experience being conservative in small cap biotechs. I'm also in Cytodyn and they just authorized another 100M so I consider their outstanding to be 800M instead of 700M.
Humanigen authorizing another 525M has definitely caused me to reassess my strategy as an investor. I'm now in for the Covid results only and it's become a lot more of a gamble because I don't like the valuation long term given the amount of new shares authorized.
The short report data is not necessarily meaningful because market makers are always shorting the stock as part of their regular operating procedures.
To loan shares out in a non margin account the customer has to be enrolled in a fully paid lending program. If you don't enroll in the program your shares can't be lent out.
Unfortunately African cases are ramping up and there has been very little testing. They are only expecting to have 60,000 test kits for the entire continent by next week.
The latest 10Q says they will need $15 million for this year so something has to happen.
There are multiple drugs targeting inflammation in ARDS
I hold a bunch of Cytodyn stock and their drug leronlimab is starting trials ASAP also. Leronlimab's benefit is that it has been shown to be very safe, like Bilracidin, in extensive trials (for HIV).
At this point the more the better. Hopefully something will work.
I think it may be the rheumatoid arthritis drug Kevzara. It's a Regeneron drug.
It's a monoclonal antibody that works against IL-6. Problem is that in trials it has had serious issues with side effects.
How closely does Brilacidin mimic the rhesus theta-defensin?
From what I understand it is based on a xenopus frog defensin. Does that make a significant difference?
Covid-19 has both positive and negative surface areas
How will this affect the potential of Brilacidin to disrupt the viral envelope?
On the bottom right of the image below the virus is depicted with the blue areas being positively charged and red areas negatively charged:
https://www.biorxiv.org/content/10.1101/2020.03.06.977876v1.full
A human centipede analogy would work also
disregard
I believe it was this interview but I don't have the time right now to find where exactly he said it.
https://www.wallstreetreporter.com/2019/12/nightfood-otc-ngtf-multi-billion-dollar-upside-in-owning-the-night-time-snacking-category/
I do think it boils down to advertising, or lack thereof. I have great confidence in Nightfood's management team in general but without the funds to mount a large advertising campaign, it's going to be difficult to get customers to choose Nightfood, a relatively unknown product,in a freezer filled with different familiar brands of ice cream.
In a recent interview, Sean mentioned that he might be open to changing the product packaging if it seems warranted. I think more straightforward artwork might help sales. Without a major advertising campaign, Nightfood is unknown to most customers so it is basically being marketed at the freezer. I think artwork that goes straight to the point of the product may be more effective than the current artwork. Drop the Cravemonster and replace it with an obvious nighttime scene and the words "the perfect nighttime snack" and "won't keep you up", or something like that.
I asked Sean about this and he had very compelling reasons for the current artwork but I still think the Cravemonster confuses the message. With the way things are now, the consumer making a quick decision at the supermarket freezer is not immediately aware of the benefit of choosing Nightfood.
I emailed Sean asking about what it takes to keep shelf space
and mentioned how Nightfood is not carried by Meijer anymore. He sent me a brief reply and didn't mention Meijer specifically but did say that in the bigger chains you get 6 to 9 months to prove your product is worthy of the shelf space.
It's a very competitive environment and there are always new products vying for the valuable shelf space. I imagine it's tough for a new company like Nightfood because they are trying to keep their position in supermarket chains while not having the money to really advertise the product the way they would like. Obviously they did a great job last year of getting noticed but now that the novelty of Nightfood has worn off, they have to figure out how to keep letting people know about the ice cream. They have been running a 2 for 1 sale right now at Lowe's Foods which ends tomorrow.
Not in Meijer anymore
I opened a small position in NGTF and am closely watching the company. I noticed that Nightfood isn't listed as available on the Meijer website anymore so I looked at the Nightfood website's where to buy section and called the Meijer stores listed...and they don't carry Nightfood anymore. It's still carried by Lowe's Foods and Harris Teeter but not by Meijer.
The stock is not on the investment community's radar at all
The stock is gathering no institutional investment and even among the biotech-aware people...I've seen multiple articles on SeekingAlpha recently by authors who specialize in biotech and when those authors were asked about Cytodyn in the comments section, they said they knew basically nothing about the company.
The Proactive videos and the like are only getting viewed by a very tiny group of people. This is good news because there is a massive pool of people to get excited about the stock but for that to happen there needs to be a major catalyst. I think the best chance for that catalyst is great preliminary cancer or NASH results. That will likely increase the SP towards the level needed for uplisting.