New Investor as of July 2013, but small biotech Investor.
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What does a 2006 article about an investor ‘road show’ have to do with today?
Maybe an email letting them know a major fda news site is lying. Sounds like they could be held liable for false information... unless, it’s not false. Gasp!
Too bad I quoted their website language.
https://www.fdanews.com/articles/198589-cytodyn-requests-eua-for-leronlimab-to-treat-covid-19-patients
CytoDyn Requests EUA for Leronlimab to Treat COVID-19 Patients
August 18, 2020
Vancouver, Wash.-based drugmaker CytoDyn is seeking an Emergency Use Authorization from the FDA for its HIV treatment leronlimab for the treatment of mild-to-moderate COVID-19 patients.
If granted, leronlimab would be the first drug authorized to treat mild-to-moderate COVID-19 patients and only the second COVID-19 treatment authorized overall. Gilead Sciences’ remdesivir is currently the only authorized COVID-19 treatment.
CytoDyn CEO Nader Pourhassan said the company is filing for emergency authorizations in “many different countries,” including the U.S. If no country grants an authorization, the company will conduct a phase 3 trial, he said.
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Your last paragraph is on point. Leronlimab has proven that it deserves EUA at the bare minimum.
Oh I get it. But at least there’s a way to get it ‘reverse engineered’ so to speak.
A wise reason for seeking approval overseas. But definitely political egg on the face if it gets approved elsewhere first.
As if NP vs Doctor mattered when prescribing! LMAO! I thought facts already settled this issue. LMAO!
Uh, I’m thinking they are requesting EUA because they have incredibly more objective and reliable data than the primary endpoint could ever give. I’m not saying that the fda couldn’t come back and ask for a phase 3. I’m not a mind reader, but I don’t see what more the fda would want.
- Leronlimab has been proven safe in over 900 people.
- It demonstrated clear and dramatically better results than Remdesivir ever did, which didn’t even include any real, hard objective data points other than a coincidental improvement in discharge time... of which, no one can pinpoint why. How is that for evidence based?
Additionally, there will be mod/severe population by which a lot of those same data points will also be available.
Don’t really see what other data the fda wants or needs in a pandemic. Just my opinion.
Let me be clear... I’m not saying the fda chose that, just that it’s possible that NP took that route because it was easier on the company resource wise. It’s possible NP saw an opportunity to just get the trial done and move resources in other areas. There’s also the paperwork/work that’s involved on both ends for the Eind too.
The fda on the other hand... their motivation is a whole different thing.
But it has to be said: Isn’t the clinical trial the only way we would get Leronlimab legitimately approved? I believe we’ve done that with phase 2 m/m results. And I for one would be infuriatingly surprised if it doesn’t get approved. But like I’ve said before,.. What President would truly allow an extremely safe, clinically proven treatment for Covid fall by the wayside during a pandemic AND an election year. It would be egg on the face, for sure.
Yeah, not arguing that. But given their staff numbers, I’m wondering if it was a resource issue primarily. Hopefully we get approval and all can benefit.
At the same time, I think Nader knew that the only way to get the best possible outcome was to push through the trial process. Anecdotal, not being the method to best get a product approved, needed to be superseded by clinical trial results. Those are the hoops to jump through, as tough as they may be.
That is why I’m eager for mod/severe data. Imagine the news2 score of them babies on top of mortality!
Gee, I thought everyone knew that a NP had prescribing authority, and the ability to order medications in the ICU arena like the ANPs at my hospital. You know... common knowledge and all. Not sure I know of someone personally who is an NP ‘claiming’ to be a doctor.
I’m still seeing Cytodyn listed on OTC. Not certain of what other people are seeing. I’ve seen confirmation that it has non-working, but trade-able ‘buttons’ appearing on the WeBull app, of which I’m not too familiar with.
It also can be a little confusing, so let me clarify the role of an RN. The role of an RN is not to prescribe (unless you are an NP), but it is our role to Advocate... BIG. GLARING. COMMON KNOWLEDGE DIFFERENCE. Sorry if that may have been too simple.
It will be interesting for sure. I guess it would def be dependent on metastasis and tumor size? But given the shrinkage of tumors in current patients, I don’t see why it almost couldn’t be both.
Great post regarding the MOA of Leronlimab. It clearly shows the value of this molecule. Thanks for sharing.
So glad I’m an RN, and don’t need any other ‘credentials’. It may be wise to heed what the MDs and those in the medical profession (particularly those making public statements about the MOA of Leronlimab on various platforms) are saying. As long as the science is sound, it’s just a matter of time. How about the science be proven wrong?
We nurses have a saying.. “We are here to save your a$$, not kiss it.”
I’m a nurse. It doesn’t take a genius to take a blood pressure and temperature. If they refuse it based on more objective and easily measurable data points, there’s something more than aloof.
That could be another factor, Misiu... timing in which it is received. Which makes sense. If the antibodies are to be viral neutralizing, once it becomes immunological, it’s benefits likely continue to wane.
Same here. Seen a few patients receive it here in Alaska. Not much hoorah surrounding it.
Multiple factors imo... finding a donor, Finding them during the three month antibody elevation period, antibody count of the donor once found, getting them to agree to donate, getting that plasma to someone who needs it... having it work...
Imo, very limited supplies, and limited priority of distribution to have a whole scale effect.
We need Leronlimab.
@stoolpresidente I'm worried about you. There's a Covid treatment called Leronlimab available @MontefioreNYC.
— Thomas Landstreet (@TomLandstreet) August 19, 2020
You should own the stock $CYDY for multiple treatment indications. Full disclosure, I own $CYDY.
For sure dude. Not overlooking the elephant that’s for sure.
Especially if you count for Leronlimab’s data as a stand alone treatment. Lack of sides, improved cytokine numbers, clinical improvement, cost savings on not using as many other drugs, decrease in drugs to drug actions, decrease stay in hospital, decrease in upgrade in care, decrease in long term side effects from Covid, boosting immune system to help with antibody production,... Yada yada
It’s a no brainer imo.
Sounds like this might be based off of Montefiore? Not sure. Good find, although some grammatical mistakes, and highly likely approval will come sooner than 6 weeks imo.
Thanks, daemon57!
They likely aren’t silent, as much as they are busy in the medical field, and don’t have time to join message board and twitter groups. They’re mostly committed to their practice... which further enhances their credibility for me.
LMAO! Great due diligence Chuckles! I love it when actual due diligence is done, cuz, you know, you get accurate facts!
Absolutely, bro!
Boo Ya!
To coin a phrase, there’s a silent underground of people who know the science and don’t need to listen to twitter jockeys. Data and the science. The rest will unfold beautifully. All in due time.
Ha ha. Right?!
CytoDyn Requests “Fast Track Approval” for COVID-19 Patients from U.K.’s Regulatory Agency MHRA based on its Top-line Report Showing Statistically Significant Endpoint, NEWS2 (p < 0.023) and Notable Safety Results
https://t.co/UYi0W4if05
Absolutely! Talking with doctors on twitter, some of which are eager to see it used for Sepsis, Anaphylaxis, and others. I’m telling you... once mod/severe data is out, all bets are off.
Of course! Because it’s the only one that has any actual data Successfully treating Covid!
Leronlimab for the win!
Word is getting out more! Leronlimab mentioned twice!
Wow. Born July 28th and an expert in all things Cytodyn. LMAO!
The fundamentals are what’s important. We didn’t seek to profit from this amazing molecule prematurely. As if the stock price has anything to do with its potential right now. LMAO!
Stay strong, Longs. The science is still on our side. EUA, nasdaq, Interim phase 2/3 data, one of the 5 companies granting EUA... Ah, I’ll keep adding while it’s cheap.
See you in December!
CytoDyn files for emergency use of leronlimab for COVID-19
Aug. 17, 2020 6:12 AM ETCytoDyn Inc. (CYDY)By: Douglas W. House, SA News Editor
CytoDyn (OTCQB:CYDY) announces that it has submitted its report to the FDA on the recently completed Phase 2 clinical trial evaluating leronlimab in COVID-19 patients with mild-to-moderate symptoms together with its request for emergency use authorization.
It has also sent the Phase 2 report to regulatory authorities in Europe, the UK, the Philippines and Mexico.
https://www.cytodyn.com/newsroom/press-releases/detail/460/cytodyn-submits-its-top-line-report-from-its-phase-2
There’s something worth taking pride in when you actually believe Doctors with decades of experience in their fields, Like Dr. Bruce Patterson, over anonymous handles, and Poly Sci Twitter Suspense writers.
It’s just plain... science. Go figure.
LMAO! And to think it’s all in black and white!
Absolutely. I really think interim is going to be major milestone.