Capella
Footballguy
I have no idea which drug is better but I sure as hell know which ceo is better.
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***OFFICIAL CYDY/Leronlimab Thread*** (9 Viewers)
- Thread starter This_Guy
- Start date
Dwayne Hoover
Footballguy
Its not a slam dunk but if you just check out how the FDA describes OLE on its site, it definitely gives the impression that approval is a strong possibility
"They are typically used when the controlled trial has ended and treatment is continued so that the subjects and the controls may continue to receive the benefits of the investigational drug until marketing approval is obtained."
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/treatment-use-investigational-drugs
This is still a strong argument in Cytodyn's favor. When you completely dismiss Cytodyn, you are completely dismissing this and I dont think that's right
I know I’ve said this before but just for the stress reduction, I’m glad I’ve been out for a while. Made way more than I would have ever expected back when we started on something I would have never known about without Chet. It also helps that most of my reinvestments have been gang busters the past half year or so. I was down 4% today, which is a lot, but I’m way less stressed about it than I was with CYDY because almost all of it is hold for 5 years because I know they’re good companies and most are growing solidly. This company has been a big ball of stress after that bear raid. Before that it was all rainbows and unicorns.
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Moonlight
Footballguy
It is my understanding that OLEs are not uncommon but usually built into clinical trial protocols to provide an option for participants to continue using the drug after the trial ends. This could occur if the participant was of the belief that the drug was of benefit and wanted to continue. I would think that this would occur more for chronic conditions than acute. Conditions such as diabetes, cholesterol etc. The OLE would permit access to the drug until it ever became available in the market.
Again I'm no expert and will yield the floor to someone with superior knowledge. That being said the OLE may have been available to CD 12 participants without any data analysis as long as the drug was determined to be safe. LL has previously had an excellent rating for safety.
But being available for OLE doesn't mean LL is being used by any participants. First, they would have to believe it was beneficial and two believe there was a need or advantage to continuing using the drug. We do not know if any CD 12 participants continued use after the trial completed and are unlikely to know based on what the company has disclosed information.
I see the distinct possibility that when CYDY says it has been granted OLE that it was built into the trial protocol from the beginning and there should be caution as to thinking that this a sign that the FDA will be approving. I haven't read the trial protocol so I cant say what was in it.
Moonlight
Footballguy
I do not know if HGEN will be approved but it seems a stronger bet based on its government and Big Pharma connections. Mayo Clinic supports it as well.
And as it relates to covid HGEN is less risky. Simply because CYDY failed on CD12. Reading the PR I cant come to any other conclusion. NP stalling with mumbo-jumbo about meeting with regulators and needing to keep things confidential. Allows him to possibly say that delays in approval are to due to the regulators and not the company and no one has data to say otherwise.
CYDY SP went down a lot after CD10 failed and it took many months to come back.
Anyway this is a CYDY board and I'm going to take a hiatus, not my intent to get into conflict. But I did like being part of the CYDY gang, it was an exciting time. But now I feel like the older brother who knows his sister is marrying the wrong fellow.
Dwayne Hoover
Footballguy
A couple of things here.
CD12 participants in this case means trial sites. These would be NEW patients that fit the criteria that the doctors at those sites can administer it too.
Secondly, I do think the data from these patients will be taken into consideration. Especially if things are close. This is my opinion only.
The one thing I don't know is how many of these are actively being used. That does make me question it a bit because I've never heard about any specific new patient anecdotals that have received this and I know NP loves his anecdotals.
Dwayne Hoover
Footballguy
I can't even legitimately argue that NP's track record with PRs that are not clear, will turn out positive. They don't.
Its the old fool me once, shame on you, fool me twice, shame on me, fool me three times, im an idiot.
I'm really skeptical too. This PR could be exactly what he says it is and everything will still be fine but he's given me no reason to trust him.
I'm willing to give a little more rope because I am playing with house money so its not going to kill me , even if went to 0. That being said, I hate giving the money back too, especially if I'm being flat out duped. Tough one.
unckeyherb
Footballguy
nosedive this morning. thanks NP!
Dwayne Hoover
Footballguy
CYDY is pretty stable today considering
Capella
Footballguy
ChiefD
Footballguy
Capella
Footballguy
shoulda been in that
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Dwayne Hoover
Footballguy
HGEN doing worse than CYDY today. I'm not celebrating this, I own both. Day to day shouldn't matter for either, aside from buying low and selling high of course. Matters more to the day traders for sure.
Anyway, I was gonna make a point here. HGEN has had no news at all today and it's tanking. People criticize Nader for being too vocal (myself included) but then Durrant not ever saying anything, is not any better for the current stock price.
I guess its a good buying day if you like HGEN, that's all.
In long run it's just as risky as CYDY though, I absolutely believe it has its own flaws. Both are still equal in that they are in the VERY speculative category.
Just kind of bugs me that you've got people that think HGEN is far superior to CYDY, they are yin and yang, just different approaches.
Will be lucky if I go 1/2 with these, both getting approvals is a grand slam. Feel like if you own one, you should probably own the other and give yourself a better chance.
Anyway, I was gonna make a point here. HGEN has had no news at all today and it's tanking. People criticize Nader for being too vocal (myself included) but then Durrant not ever saying anything, is not any better for the current stock price.
I guess its a good buying day if you like HGEN, that's all.
In long run it's just as risky as CYDY though, I absolutely believe it has its own flaws. Both are still equal in that they are in the VERY speculative category.
Just kind of bugs me that you've got people that think HGEN is far superior to CYDY, they are yin and yang, just different approaches.
Will be lucky if I go 1/2 with these, both getting approvals is a grand slam. Feel like if you own one, you should probably own the other and give yourself a better chance.
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Capella
Footballguy
Capella
Footballguy
I don’t know why it’s tanking today but the reason people feel way better about it is because it’s on nasdaq and the ceo is seemingly quite good and has connections.
BassNBrew
Footballguy
And he isn't selling fake dream catchers when he's not dumping shares of his own stock.
Charlie Harper
Footballguy
NASDAQ uplisting. HIV BLA. These are material things that NP made it seem like they were imminent.
Hard to believe they aren't stringing this along after failing to deliver.
Dwayne Hoover
Footballguy
Connections are only as good as the drug can take you, especially for a tiny company like HGEN or CYDY.
I'm not arguing that connections aren't helpful they certainly are and is the big selling point for HGEN to me as well. I just don't know that the drug is as effective, can be used for as many indications, patient populations, etc.
Feel like HGEN is flawed too and their investors never know what is going on because the CEO never talks period. If you could find the best parts of Nader and combine it with Durrant, you may have a kick ### CEO
chet
Footballguy
Capella
Footballguy
chet
Footballguy
Chaz McNulty
Footballguy
That's optimistic. It will look bad on the FDA if they end up with those numbers. 500K deaths, while an underfunded company was trying to get a drug through for the past 11 months that could have save 250K lives. There would end up being some process changes for sure.
chet
Footballguy
Chaz McNulty
Footballguy
One of my biggest problems with the last PR is that they reported that the trial was unblinded and they are discussing the results with the FDA.
The discussions are confidential. Which makes sense.
It does not say that the results are confidential (and why would they be). What advantage is it to Cytodyn to hold back great results? If they reached statistical significance, it would make sense for them to publish them. Wouldn't you want to get the word out and build momentum for all the prospective buyers out there. I don't see any advantage in staying quiet.
I believe they missed their endpoint for 28 days and are in discussions regarding the 42 day results. Still a good chance and that's why I'm still in.
The discussions are confidential. Which makes sense.
It does not say that the results are confidential (and why would they be). What advantage is it to Cytodyn to hold back great results? If they reached statistical significance, it would make sense for them to publish them. Wouldn't you want to get the word out and build momentum for all the prospective buyers out there. I don't see any advantage in staying quiet.
I believe they missed their endpoint for 28 days and are in discussions regarding the 42 day results. Still a good chance and that's why I'm still in.
Dwayne Hoover
Footballguy
Something like this for sure..hopefully they even have 42 day data to look at!
I know we don't have any real insight into what is going on but in all scenarios I have a hard time picturing the data is great and that they can't share it yet
Then I go on Yahoo and all those idiots are SURE that the data must be great.
People read into this in the manner that it makes the best sense for them
kevzilla
Footballguy
That's a pretty solid definition for confirmation bias, something we all need to be watching for
unckeyherb
Footballguy
This where I’m at. The mortality rate from 28 days to 42 days increases substantially. It’s in this timeframe that I think they are significant. I hope they kept data out that far even though they didn’t officially add it as an endpoint.
unckeyherb
Footballguy
Here is the chart from RLFTF trial. Take a look at the SOC survival rate after 28 days. It’s shocking.
Dwayne Hoover
Footballguy
Something else that Nader screwed up if they need this data and don't have it.
DSMC recommended this at the 75% interval, NP decided they didn't need a look at 75%. I really hope he got that right.
Something else I heard parroted by all those idiots at Yahoo. they assured that 42 days only mattered at 75% and that at 100% they would achieve stat sig at the 28 day.
Will see if they are right but Im extremely suspicious this is wrong
Dwayne Hoover
Footballguy
Chaz McNulty
Footballguy
When I first read that chart i was shocked. But I think I am reading it wrong. The chart seems to indicate that at day 49, only 15% of the SOC patients are still alive. I am obviously missing something.
unckeyherb
Footballguy
Agreed. It was obviously a mistake to not add the 42 day endpoint. That doesn’t mean the data wasn’t kept-frankly, it’s as simple as “at day 42, how many are dead”. Tracking the mortality rate out to whatever day you want should not be difficult to assess.
unckeyherb
Footballguy
I read it as probability of survival dropped to 15% by day 49 under SOC. Down from about 79% probability at day 28. If that is correct than it’s clear to me that they probably missed statistical significance at 28 days and are (hopefully) working with FDA on 42 day endpoint. As was said above, they should have taken the advice at 75% but if the data is there, it really shouldn’t matter. If they barely missed SS at 28 days when the SOC survival rate was 79% then it would stand to reason that they crushed it at 42 days.
ETA It should be noted that this info is from a different trial. The mortality rates in LL Cd12 are almost certainly different, but probably not much different.
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Chaz McNulty
Footballguy
But that would indicate an 85% death rate for anyone in the S/C stage. That sounds way to high from what I hear.
Dwayne Hoover
Footballguy
Is this source at all reputable? I just can't take much from a random source, anyone can post whatever they want
Don Hutson posted crazy stuff all the time, im sure someone quoted him somewhere
Dwayne Hoover
Footballguy
unckeyherb
Footballguy
The Blue Baron
Footballguy
Key takeaways on trial info we have for lenzilumab:
Mayo Clinic reported patients treated with lenzilumab had a hospital stay of 5 days compared to 11 for the untreated group.
https://www.mayoclinicproceedings.org/article/S0025-6196(20)30989-7/fulltext
Interim results reported 37% more recoveries among patients who received lenzilumab versus SOC. Why did CytoDyn not look at interim results? HGEN also has all the right partnerships along with government funding. Who knows, they may report their results before CYDY. The PR release by CytoDyn was a huge disappointment, as evidenced by the share price. They obviously did not hit their primary endpoint and are looking for a subset to take to the FDA. They will likely pivot to long haulers, HIV, and cancer. If that is the scenario, many shareholders will exit their positions. With bills to pay and no revenue likely from HIV until 2022-Assuming BLA submitted, you’re looking at a drop to $1 or less.
I have a small position in HGEN, AVIR and EDSA and larger in PFE, BNTX, RHHBY, and RGEN for stocks involved with COVID. I am completely fed up with CytoDyn management.
Mayo Clinic reported patients treated with lenzilumab had a hospital stay of 5 days compared to 11 for the untreated group.
https://www.mayoclinicproceedings.org/article/S0025-6196(20)30989-7/fulltext
Interim results reported 37% more recoveries among patients who received lenzilumab versus SOC. Why did CytoDyn not look at interim results? HGEN also has all the right partnerships along with government funding. Who knows, they may report their results before CYDY. The PR release by CytoDyn was a huge disappointment, as evidenced by the share price. They obviously did not hit their primary endpoint and are looking for a subset to take to the FDA. They will likely pivot to long haulers, HIV, and cancer. If that is the scenario, many shareholders will exit their positions. With bills to pay and no revenue likely from HIV until 2022-Assuming BLA submitted, you’re looking at a drop to $1 or less.
I have a small position in HGEN, AVIR and EDSA and larger in PFE, BNTX, RHHBY, and RGEN for stocks involved with COVID. I am completely fed up with CytoDyn management.
BassNBrew
Footballguy
They can't pivot. They are sitting on dated inventory. They went all in on covid and if they don't get approval the bankruptcy court is dividing up their $70k in printers and office TP to distribute back to shareholders.
Capella
Footballguy
Dwayne Hoover
Footballguy
Let's see what this data looks like
If it comes down to a poorly designed trial that dooms them, I still think at very least they would be a candidate for a buyout, if they even needed to go that route
The HIV BLA is looming too. Not gonna pretend I know what is going on there and how close they really are but I'll estimate at least a 10% chance that is completed soon.
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unckeyherb
Footballguy
Fidelity showing $4.37 pre-market. Did I miss something?
