Capella
Footballguy
I thought last we heard, they haven’t even filed for that? Is that bad info or is this a new development?
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***OFFICIAL CYDY/Leronlimab Thread*** (7 Viewers)
- Thread starter This_Guy
- Start date
chet
Footballguy
I don't think so. This is the first I've heard of an EUA application. Now the pressure is on the FDA--the application implies there was some sort of discussion with the FDA where they either encouraged CYDY to apply or said something like it can't hurt. I believe there have been other instances where the FDA has actually said, we don't think you should apply for approval.
Capella
Footballguy
I guess until I see the proof I won’t believe it. Guy has lied/manipulated words the entire time. I’m hopeful though.
Steeler
Footballguy
dkp993
Footballguy
What are you talking about? He said major news from the Philippines within 48 hours. That was only 10 days ago.
Chaz McNulty
Footballguy
Is there such a thing as a Conditional EUA? I thought an EUA was already a conditional approval.
BassNBrew
Footballguy
J doesn't allow train wreck threads in the Shark Pool so all Cowboys discussion gets sent here.
chet
Footballguy
Optimistic view:
FDA encouraged conditional EUA for ethical reasons. Forcing CYDY to conduct CD16 would cost lives because the OLE and eIND usage would be stopped. CD16 and conditional EUA cannot be conducted at the same time because no one would enter the trial and risk getting placebo--they would make use of the EUA and have 100% certainty of receiving drug. I think the FDA might have said we will grant the conditional EUA but will watch performance of the first 100 patients to ensure their recovery is inline with the critical patients in CD12. The continuation of the conditional EUA approval is dependent on how the patients fare.
FDA encouraged conditional EUA for ethical reasons. Forcing CYDY to conduct CD16 would cost lives because the OLE and eIND usage would be stopped. CD16 and conditional EUA cannot be conducted at the same time because no one would enter the trial and risk getting placebo--they would make use of the EUA and have 100% certainty of receiving drug. I think the FDA might have said we will grant the conditional EUA but will watch performance of the first 100 patients to ensure their recovery is inline with the critical patients in CD12. The continuation of the conditional EUA approval is dependent on how the patients fare.
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dkp993
Footballguy
Chaz McNulty
Footballguy
I really hate the word play in the title of the press release.
Why is the word 'expected' in there? It pisses me off that they haven't filed yet.
And then in the body they use the word recent.
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chet
Footballguy
From the body of the PR:
It seems like they have filed in the UK, Canada and here.
ILUVBEER99
Footballguy
Has Dr Yo written a letter yet?
chet
Footballguy
Yo, yo, yo, Dr. Wood.
It's Yo here and it's time you focused on rantes and not your panties.
The Gator
Footballguy
chet
Footballguy
OMG This guy is trying to explain the new rules around shorting which come in effect tomorrow. I have no idea if he explained them will because I couldn't stop staring at his wolf headband and his zit which is next to his philtrum and partially covered by his cheesy mustache.
Chaz McNulty
Footballguy
This was posted on the Cytodyn facebook site. Would love to hear a response.
BassNBrew
Footballguy
Dear Dr. Kelly,
What price did you and your wife get for your shares during the review period?
What is the shelf life of the the LL in your warehouse?
Have did you beat NP to the offices supplies before the bankruptcy filing?
Will your company handle the bankruptcy filing better than the BLA filing?
chet
Footballguy
Dwayne Hoover
Footballguy
Dwayne Hoover
Footballguy
chet
Footballguy
Just posted this to reddit:
P-value vs.trial power--CYDY vs. Woodcock
Woodcock in her webinar yesterday implied that any trial needed to have 400+ participants for the trial to be powered enough to be statistically significant. She has also said that p-value shouldn't be an impediment to saving lives.
CYDY showed statistically significant results for the critical cohort in more than one endpoint with total patients far below 400.
The FDA has chosen 0.05 as the bright-line test as to statistical significance. If any trial shows a p-value less than 0.05, it should be recognized as statistically significant. If an endpoint shows a p-value of 0.10 or below, it means that the result was still overwhelmingly likely to be because of the drug but that there weren't enough patients--i.e. it was probably under powered or in other words, not enough participants.
That being said, any result that shows a p-value below 0.05 proves the drug's efficacy per the FDA's guideline. It's much harder to achieve that result with a low number of patients but it doesn't invalidate any result that is significant simply because there were a low number of patients. A statistically significant result stands regardless of the number of patients.
We have a wonder drug with a management team that is incredibly incompetent. We have to help them achieve conditional EUA approval.
P-value vs.trial power--CYDY vs. Woodcock
Woodcock in her webinar yesterday implied that any trial needed to have 400+ participants for the trial to be powered enough to be statistically significant. She has also said that p-value shouldn't be an impediment to saving lives.
CYDY showed statistically significant results for the critical cohort in more than one endpoint with total patients far below 400.
The FDA has chosen 0.05 as the bright-line test as to statistical significance. If any trial shows a p-value less than 0.05, it should be recognized as statistically significant. If an endpoint shows a p-value of 0.10 or below, it means that the result was still overwhelmingly likely to be because of the drug but that there weren't enough patients--i.e. it was probably under powered or in other words, not enough participants.
That being said, any result that shows a p-value below 0.05 proves the drug's efficacy per the FDA's guideline. It's much harder to achieve that result with a low number of patients but it doesn't invalidate any result that is significant simply because there were a low number of patients. A statistically significant result stands regardless of the number of patients.
We have a wonder drug with a management team that is incredibly incompetent. We have to help them achieve conditional EUA approval.
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Charlie Harper
Footballguy
If it don't make sense, it don't make dollars.
chet
Footballguy
Capella
Footballguy
Chaz McNulty
Footballguy
chet
Footballguy
Chaz McNulty
Footballguy
Most of the lawsuits are probably nuisance ones, but I could see NP getting in trouble for falsely pumping the stock right before the release of trial data.
Dwayne Hoover
Footballguy
I hope he is locked up and if that's wishful thinking, at least hope the board is smart enough to remove him.
This was the final straw with this idiot for me. I still can't believe he did that in the face of failed primary endpoints. What a jackass
dkp993
Footballguy
Capella
Footballguy
Chaz McNulty
Footballguy
Not if they announce on Monday's CC that they aren't going to apply for an EUA with the FDA.
Capella
Footballguy
There’s always buyers for this crap. I don’t think it even got into the dollar range after this last debacle.
Chaz McNulty
Footballguy
I'm torn, but I think I am going to sell tomorrow and rebuy on Tuesday. The stock price always seems to go down after a CC.Capella said:
The Blue Baron
Footballguy
Interesting post on SA that garnered 8 likes:
“This is gross. Recknor and his wife own CARE which is running the LH trial. CYDY is paying them $2.5m. Recknor invested $1m in November and got 670,000 shares at 1.50 when stock was above $2. He now is making 400k plus 50% cash bonus plus stock options. How the heck can this be legal. A man/family that has $4m tied to the company running a clinical trial.”
I see more and more of these types of notices when googling. It always bothered me with the timeline and number of studies involved for HIV. They need to clear this up.
https://clinicaltrials.gov/ct2/show/NCT02859961?term=leronlimab&draw=2&rank=9
“Kessler Topaz is one of the world’s foremost advocates in protecting the public against corporate fraud and other wrongdoing. Our lawyers regularly take on the foremost defense attorneys—and win—in class actions, shareholder derivative suits, antitrust litigation and other complex litigation around the globe. We are proud to have recovered billions of dollars for our clients.”
https://www.ktmc.com/new-cases/cytodyn-inc-1#overview
“This is gross. Recknor and his wife own CARE which is running the LH trial. CYDY is paying them $2.5m. Recknor invested $1m in November and got 670,000 shares at 1.50 when stock was above $2. He now is making 400k plus 50% cash bonus plus stock options. How the heck can this be legal. A man/family that has $4m tied to the company running a clinical trial.”
I see more and more of these types of notices when googling. It always bothered me with the timeline and number of studies involved for HIV. They need to clear this up.
https://clinicaltrials.gov/ct2/show/NCT02859961?term=leronlimab&draw=2&rank=9
“Kessler Topaz is one of the world’s foremost advocates in protecting the public against corporate fraud and other wrongdoing. Our lawyers regularly take on the foremost defense attorneys—and win—in class actions, shareholder derivative suits, antitrust litigation and other complex litigation around the globe. We are proud to have recovered billions of dollars for our clients.”
https://www.ktmc.com/new-cases/cytodyn-inc-1#overview
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Chaz McNulty
Footballguy
Chaz McNulty
Footballguy
Here is the 8K discussing this.
https://www.marketwatch.com/investing/stock/cydy/SecArticle?guid=14802042
In a normal world, I would agree that this looks to be a huge conflict of interest. And if you looked at the enrollment rate at the end of CD12, it may have had something to do with the sites run by CARE.
But if you look at this in comparison to what the rest of BP is doing, its really insignificant. If we turned over a few rocks at Gilead, you would see way worse. The same goes for the incestuous relationship that BP has with the FDA. That's even more gross.
chet
Footballguy
Please sign this petition to help get this girl's grandmother LL. The ####### doctor agreed to get LL and then changed his mind when he found out there was paperwork.
The Blue Baron
Footballguy
My issue with it is the HIV BLA being delayed for so long and then there is the delay with starting the BLA. They also have way too many trials on line for HIV. I believe they consolidated some-As I believe there were more before.
Dwayne Hoover
Footballguy
Are you sure? This seems like some major conflict of interest. Seems shady to me but typical Cytodyn
dkp993
Footballguy
It’s awful out in the open if it’s shady. They had to file and let everyone know. That’s like robbing a bank in broad daylight with no mask and a name tag. Well now that I think about it, perfectly in line with NP.
Chaz McNulty
Footballguy
It's a little suspect also, for the long hauler trial. This trial is way more subjective about how the patient feels, and there's not a whole lot of analytical data compared to most trials. Patients can be coached for sure.
unckeyherb
Footballguy
No volume today, not a single post here. I guess everyone is wearing concrete shoes waiting for this stupid CC tonight. If there is not really positively impactful info given tonight, I am not looking forward to tomorrow.
Chaz McNulty
Footballguy
They probably just need to say that they applied for an EUA last week. This will keep the stock where it is. If they haven't applied, then we all get an opportunity at cheap shares tomorrow!
Capella
Footballguy
Dwayne Hoover
Footballguy
Im a little out of pocket but am always interested in the CC, even if its gonna be a trainwreck
If anyone hears anything interesting, can you post it.
I'm 100% out of CYDY at the moment but still keeping an open mind
If anyone hears anything interesting, can you post it.
I'm 100% out of CYDY at the moment but still keeping an open mind
