Capella
Footballguy
I thought last we heard, they haven’t even filed for that? Is that bad info or is this a new development?Fingers crossed.
I thought last we heard, they haven’t even filed for that? Is that bad info or is this a new development?Fingers crossed.
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.I thought last we heard, they haven’t even filed for that? Is that bad info or is this a new development?
I guess until I see the proof I won’t believe it. Guy has lied/manipulated words the entire time. I’m hopeful though.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.
In two weeks.Maybe they're confident that they hope that they can have discussions with the FDA about the possibility of potentially submitting a pre-application for an EUA
What are you talking about? He said major news from the Philippines within 48 hours. That was only 10 days ago.I guess until I see the proof I won’t believe it. Guy has lied/manipulated words the entire time. I’m hopeful though.
Is there such a thing as a Conditional EUA? I thought an EUA was already a conditional approval.Management will update stockholders on the Company’s recent COVID-19 related filings for Conditional EUA with the FDA in U.S., Interim Order in Canada, and accelerated rolling review in U.K., as well as potential similar filings in Brazil and the Philippines. Management will also provide updates on its active trials in COVID-19, NASH and Cancer, along with expected timelines for BLA submissions for HIV in U.S., Canada and U.K.
J doesn't allow train wreck threads in the Shark Pool so all Cowboys discussion gets sent here.Whenever I see this thread title at a quick glance I always think it says the "Official CD Lamb" thread. Then I wonder why it's in the FFA
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 conditional EUA approval is dependent on how the patients fare.
I really hate the word play in the title of the press release.Management will update stockholders on the Company’s recent COVID-19 related filings for Conditional EUA with the FDA in U.S., Interim Order in Canada, and accelerated rolling review in U.K., as well as potential similar filings in Brazil and the Philippines. Management will also provide updates on its active trials in COVID-19, NASH and Cancer, along with expected timelines for BLA submissions for HIV in U.S., Canada and U.K.
Why is the word 'expected' in there? It pisses me off that they haven't filed yet.CytoDyn to Hold Webcast on March 22 to Provide an Update on COVID-19 Initiatives and Expected Regulatory Filings with the U.S., U.K., Canada, Philippines and Brazil
Management will update stockholders on the Company’s recent COVID-19 related filings for Conditional EUA with the FDA in U.S., Interim Order in Canada, and accelerated rolling review in U.K., as well as potential similar filings in Brazil and the Philippines.
From the body of the PR: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.
It seems like they have filed in the UK, Canada and here.Management will update stockholders on the Company’s recent COVID-19 related filings for Conditional EUA with the FDA in U.S., Interim Order in Canada, and accelerated rolling review in U.K., as well as potential similar filings in Brazil and the Philippines.
Yo, yo, yo, Dr. Wood.Has Dr Yo written a letter yet?
Dr YoWhich one was the rantes not panties guy.
Man there were so many signs lol
Dear Dr. Kelly,
I emailed you last week expressing my mounting concerns associated with the CYDY leadership. My concerns are not limited to me, personally, but express a growing sense of anxiety among many shareholders, stemming from recent (and not so recent) management activities.
To be clear, I have seen enough in the peer-review literature to reach the obvious conclusion: (leronlimab) LL works. Nevertheless, the last few days and weeks have been concerning. Given these concerns, the following issues are a collective set of questions that require attention. I realize you, and the rest of management, are likely quite busy with present matters - nevertheless, addressing the growing concerns of shareholders must also be a priority. Please note that I am communicating these questions on the CYDY Shareholders Facebook Page, a group that is home to >3000 members.
1) It has previously been said, by Dr. Mahboob Rahman, that receptor occupancy isn’t needed, specifically by the MHRA. Why has there been at least a 6 month delay in submission?
2) Receptor occupancy shouldn’t be an issue at this point. What’s the barrier to completion? Or is receptor occupancy the main issue?
3) How does Dr. Pourhassan not know the answer to the Philippines sales question posed at the most recent Investor Call? That’s literally his #1 job as CEO. As shareholders that have invested considerably, he needs to know the #1 priority is to find a sales outlet for LL. Anywhere!
4) Please address unequivocally when the CSP with Philippines is/was filed. Dr. Pourhassan explicitly mentioned a "48 hour" window of time at the most recent Investor Call - that was more than 1 week ago. What is the status with the submission to the Philippines?
5) Please address when the interim order with Health Canada will be filed.
6) Please address unequivocally whether a EUA will be filed (re: COVID-19) or has already been filed with the FDA?
7) What is the current status of Dr. Pourhassan's tenure as CEO? Shareholders are incredibly frustrated that little progress has been made toward viable revenue. There are constant delays and over statements bordering on the insane. Dividend talk from a company looking at a share offering? Multiple incredible bungles that most CEOs don’t make. The shorts fear LL. They know they’re safe with Dr. Pourhassan at the helm.
8 ) Have we fired the PR firm who did the press releases for CD-12? Why not? What is the company's marketing strategy going forward?
9) How is CYDY going to enroll CD16 knowing there is s/s benefit without ending eIND and OLE? Has the FDA been addressed with this ethical concern?
10) Is CYDY looking at anyone other than Amarex? They seem to have botched the trial for us and took a long time to turn around the data when compared to others (e.g., RLFTF).
An increasingly concerned shareholder,
Respectfully, Matei Georgescu
Dear Dr. Kelly,This was posted on the Cytodyn facebook site. Would love to hear a response.
The only relevant question IMO.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?
Dr Yo was the most wrong of everyone because it definitely turned out to be pantiesWhich one was the rantes not panties guy.
Man there were so many signs lol
Haha, no chance Kelly even acknowledges it, let alone answer a questionThis was posted on the Cytodyn facebook site. Would love to hear a response.
That is definitely not the way the FDA works lolI have a hard time believing this claim could be true, but if it is, then heads need to roll.
Definiteley BS. Just someone trying to get everyone to send emails.I have a hard time believing this claim could be true, but if it is, then heads need to roll.
From someone who's very credible in my book.That is definitely not the way the FDA works lol
It is not made up. Have confirmed that the number is real and an associate has called the number and spoken with a clinical pharmacist. His advice was to have more MDs and Scientists call in to express their medical/scientific opinion on why leronlimab should receive more attention at the FDA.
Probably not a good idea to call as an 'investor' or to call with the intent to badger or be critical of the FDA, IMO.
However, I'm all about spreading the word to your MD friends and colleagues!
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.
I hope he is locked up and if that's wishful thinking, at least hope the board is smart enough to remove him.I could see NP getting in trouble for falsely pumping the stock right before the release of trial data.
also apparently "48hrs" is his new "2 weeks"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
Doesn’t make sense to me to sell at this point. We’ve probably seen the floor.So, because I'm incredibly ignorant and busy, are we selling our CYDY shares or have I already missed the boat on doing so?
Not if they announce on Monday's CC that they aren't going to apply for an EUA with the FDA.Doesn’t make sense to me to sell at this point. We’ve probably seen the floor.
There’s always buyers for this crap. I don’t think it even got into the dollar range after this last debacle.Not if they announce on Monday's CC that they aren't going to apply for an EUA with the FDA.
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:There’s always buyers for this crap. I don’t think it even got into the dollar range after this last debacle.
Can you unwind this one for me. What is the exact issue?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
Here is the 8K discussing this.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.”
My 78 year old grandmother, Leida has COVID & is on a ventilator at NYP Hospital. Death is imminent. We like many others want every chance to fight for her life. We almost lost a 70 year old family member to COVID last year, he was given the medication leronlimab under compassionate use eIND. It saved his life. The drug manufacturer agreed to give leronlimab to grandma IF her doctor will complete the paperwork. This medication is FDA approved under compassionate use. Her attending, Dr. Gregg Rosner originally agreed, but backtracked when he realized the paperwork involved. He said it is not worth his time & resources. @nyphospital supports him. Please join us in asking for compassion & give Leida the chance to live
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.Can you unwind this one for me. What is the exact issue?
Are you sure? This seems like some major conflict of interest. Seems shady to me but typical CytodynBut 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
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.Are you sure? This seems like some major conflict of interest. Seems shady to me but typical Cytodyn
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.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.
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!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.
THANKS FOR THE CHEAP SHARES SHORTIES HAHAHAHAHThey 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!