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28 new CSP Patients at a hospital in the Philippines. That's not a trial, every patient gets Leronlimab, news of remarkable recoveries will be coming out as soon as next week. The first patient was released from the hospital in 3 days. This is the beginning of CytoDyn selling 100,000 vials in the Philippines.
https://www.cytodyn.com/investors/news-events/press-releases/detail/519/cytodyn-providing-leronlimab-to-a-philippine-hospital-for
I agree, thinking the same thing. For all we know buyout negotiations could be complete, just waiting on approval.
There was something else also, NP was giving details on valuation of buyout, I missed exactly what was said but he mentioned phase 2 and 15% of value? Did you happen to catch that, any idea?
Well at least the wheels are turning, there is CSP approval and patients are getting Leronlimab right, it has to start somewhere so next week if the additional 28 patients show remarkable recovery it will be known right away, its not a trial so no waiting on data.
NP mentioned while talking about the Philippines that they would accept eIND approval from host country as an approval. So it looks like they are testing the waters with their CSP approvals, if this is the case it won't be long before they allow sales of Leronlimab.
Canada is in bad shape with critical covid patients. They are struggling to find ecmo machines and staff. Meanwhile they have been reviewing Leronlimab for two weeks now which has a 82% reduction in mortality among critical covid patients. Approval should be any day now.
https://torontosun.com/news/national/hospitals-deploy-artificial-lungs-scramble-for-staff-as-covid-19-hits-younger-patients
"There might be some small benefit in some small subset of patients"
You conviently left out that subset is critical covid patients, that's not a small subset. Leronlimab has a 82% survival benefit for critical Covid patients.
Canada is scrambling to find ecmo machines for their critical covid patients. Leronlimab is currently under review as a treatment for critical patients in Canada. It will be approved.
https://www.reuters.com/article/us-health-coronavirus-canada-hospitals-idUSKBN2BT2JE
AND ASK THEM WHAT?!!! Ask uh duh..is your updated list for real???
IT UPDATED TODAY!!
DEBUNKED
LAUGHING
Nah, your link is old hasn't updated since 3/23. That's the day CytoDyn applied.
"Date modified: 2021-03-23"
And completely unrelated link, Leronlimab is on the COVID-19 for INTERIM ORDER link which was updated today and showing still under review.
DEBUNKED
https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/authorization/applications.html
WRONG updated today and still under review. But didn't see HGEN anywhere on it.
https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/authorization/applications.html?fbclid=IwAR14pvaRVgg-OOuZdya3PGt2lO6Cwooj4bWHvQVCy_oPr0YOuhQ1ZK5xcE0
“I want to reiterate our commitment to the Philippines of at least 100,000 doses upon the FDA Philippines granting Emergency Use Authorization (EUA).
“We believe this anecdotal data and more than 90 approved eINDs (emergency IND) in the US along with the results of our CD12 of 384 mITT (modified intent to treat), double-blinded study that had 82% reduction in 14-day mortality of critically ill, mechanically ventilated patients with statistically significant p-value is a compelling reason to move forward with the EUA request in the Philippines.”
https://www.clinicaltrialsarena.com/news/cytodyns-leronlimab-shows-improvement-in-csp-patient-with-covid-19/
The CSO? A deposition? Doesn't make sense at all, sounds like fantasy land weak attempt at FUD. The CSO would be in Maryland discussing Leronlimab's MOA with the FDA to finalize the EUA.
Could he be on a plane heading to Maryland?
"sufficient quantities of leronlimab"
CytoDyn is ensuring that they have two billion dollars worth of Leronlimab PER MONTH that would almost be sufficient. Samsung can crank out at least one million viales per month looks like the first million is going to the Philippines.
Out of curiosity did you notice CYDY is up 100% from $2 two weeks ago when you said it was going to $1.
It seems the market believes him. Does that mean the market doesn't believe HGEN claims to have met endpoints?
That's another fantasy that only lives in your head. The reality is 82% reduction in mortality for critical covid-19 patients. And with that data CytoDyn applied for EUA in multiple different countries.
Wow that's quite the conspiracy theory you have! And to think Nader came up with a history changing life saving drug just to rip people off. He's brilliant, come up with a drug that cures HIV, helps cancer patients live longer, gets people of ecmo just to rip people off, yeah make alot of sense.
1. GM-CSF meaningless the market doesn't care
2. Manicured manipulated results will most likely need another trial
3. Management with no drug to sell and diluting the share holder
Up 109% from where? From $14? That's not impressive in fact it's embarrassing then it dumped 50% back down to it's normal high. This stock has no support, nobody is buying. Just because a bio meets their endpoint doesn't mean the price is going to sky rocket and hgen is showing that. It's definitely not a good buy right now, it's going lower, $15 would be a decent entry then dump the news when they announce applying for EUA like everyone else is going to do.
The truth is Leronlimab is currently under review with multiple different countries for treatment of covid-19. And it will be approved. HGEN hasn't even applied anywhere AND doesn't have a product to sell. They have a long way to go.
It tanked BEFORE the offering. The offering made it worse. Ha! Two weeks??!! You'll be lucky if they even apply in two weeks, then the FDA will schedule a meeting in another couple weeks your looking at least a month most likely longer, and that's even if it gets approved. In the meantime HGEN will bleed down starting with Monday now that the offering is even lower.
There is no reason for HGEN to tank after announcing ground breaking news..but it did. Not a bad strategy you have there, if, and that's a big if, your time line holds true. The thought of a quick EUA might happen if the FDA breaks from normal procedures, I can't see that happening and the company hasn't even applied yet that might even take some time. Meanwhile CYDY has already applied in multiple different countries, some even so interested they approached CytoDyn asking to see the data.
They CLAIM to have met the endpoint, on a manipulated, manicured trial, pretty much cooked the data to where they wanted it. We'll see if the FDA agrees, or want a more accurate trial.
Not a chance. When pfizer announced they applied for EUA for the covid vaccine it was a couple days later the FDA scheduled a meeting in another two weeks, the EUA approval was announced days after that. That was pfizer, the FDA under pressure and the world watching. HGEN hasn't even applied for EUA yet, let alone received a response. It's going to take some time.
You have absolutely 100% no idea who this congressman's connections are. Let's see... it's called the federal government....for all you know he could have a former staffer now working in the FDA, a close friend working in the FDA, maybe he just called over there and they told him. Show me the letter where his office denied this.
There's nothing in the letter that looks fabricated. If it was the congressman's office would obviously release a statement saying it was.
83% reduction in mortality makes it clear that Leronlimab works and should have been 4 shots. That's strong data, strong enough for CD12 to advance to phase 4 with the new protocol and EUA approval.
"leronlimab reached only one person" that's the exciting part Leronlimab reached that one person because it is now APPROVED in the Philippines. With 100,000 viles set aside for the Philippines that's over $150,000,000 in revenue for CytoDyn. But all that won't even matter now that a congressman is saying the FDA will approve Leronlimab. With an FDA approval CytoDyn's 1.3 million vile inventory will be sold in a few months.
Philippines is looking at all the data, including early eIND patients. I would assume other countries are doing the same.
"after several weeks of discussions with the U.S. Food and Drug Administration (“FDA”) and analysis of CD12 trial data, and in particular the 82% survival results over placebo after two weeks of leronlimab treatment, with statistically significant p-value of 0.0233, the Company has filed a new protocol to extend treatment to four weeks. The Company will initiate patient enrollment in multiple countries, including Brazil, where there are over 20,000 COVID-19 patients in ICU.#
Phase 4 in Brazil with EUA approval would save many lives
https://www.cytodyn.com/investors/news-events/press-releases/detail/513/cytodyn-files-new-protocol-with-u-s-fda-for-4-doses-of
Month 4...4 shots...phase 4...4 EUA approvals
I wouldn't be so sure about that. HGEN reached $29 sellers came in which is understandable, longs taking some profit, but after the sell off would have expected support with new investors and maintained the high, it didn't happen, it crashed, this was before the offering.
So they claim, just because they claim to meet a manicured endpoint doesn't gaurentee an EUA approval, and if they do get an EUA it doesn't mean the market will react positive. You know that feeling you got in your stomach when the share price barley reached normal level then crashed after endpoint was announced? Wait till EUA and it does the same.
4 is the number. 4 shots..phase 4..month 4.. CYDY $40
That’s how I got anecdotes off ECMO!! Three or four doses (as in the just published UK patient). Treat until RANTES and IL-6 normalize! https://t.co/dugK5eopsG
— Bruce K. Patterson MD (@brucep13) April 2, 2021
WRONG! CD12 is still recruiting and OLE is part of the trial. I'll go with the FDA not your wrong opinion.
https://clinicaltrials.gov/ct2/show/NCT04347239
CD12 is still recruiting and now with the new protocol sending it to phase 4 with EUA approval the dude will have billions in revenue to show for it.
HGEN drug looks good but from long-term investment standpoint I'm not so sure. The company doing an offering before EUA looks sketchy, and not having product to sell is never good. With CYDY approval doctors will have a hard time getting insurance to approve iv infusion of lenz when LL is a shot.