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Pretty sure that’s already happened. No on P2 EUA... continuation of P3 and evaluation at mid. No EUAs until mid-October.
CytoDyn won’t PR that as it would hurt SP and they need that for Naz. So they stay silent until they have good news.
Sure, why not... we don’t have a choice.
Saunders also said Chas would reach out to shareholder soon (in June).
This is hilarious... if Chas can’t pick up the phone how is he going to act as a CEO? Lol.
Whatever... this is all just noise. Bottom line is the company is dead until they prove otherwise.
SOC helps M2M, S2C critical still need a lifeline like leronlimab. Deaths are still 1k/day.
FDA has an answer but they are too scared to approve it.
At this point it would be better to just post ads on hospital ride share boards advertising leronlimab. “Ask your doctor how today!”.
If I’m S2C then I find a doctor who can get me leronlimab. I don’t rest til then or death.
Lmao... NP should not put all of his eggs in the FDA basket. Diversify your market NP. Go global.
The FDA is lost right now... they will fumble around until vaccines are ready. Effective or not.... just like Remdesivir.
Lol... what?
Lockness monster stole his Magnetec machine? What a disaster...
Yes, he knows and when asked about mabs in the senate he redirected the questions to antivirals like remdesivir.
I’ve seen enough footage on Cspan of that guy to know he’s pro-Gil and anti-Mab.
I guess I’m glad I didn’t hear from him? Lol.
Probably best to consider this dead...
I’m not even interested in being teased with hopes and dreams anymore. This company is a joke and a shell.
Maybe Biz can drum up some interest for a buyout and or a RM to take over patent assets.
Even the Titanic fired off flares into the night.... Chas doesn’t even have that it appears.
In the OTC it is..
Not just yet... NP just underestimated the task and predicates. X 2 anything he says... so 12 weeks and maybe Naz.
EUA for P2 M2M is likely denied... too small of a data set and FDA is old school. They need more data.
Nope, only evidence is the absence of an approval and ample time to reply. Onto P3 mid... maybe EUA in October, otherwise December.
MaBs too new for the FDA... they want more data to show it’s safe and effective.
Pretty sure they already did... it was a no.
Lol. This is the same company that forgot to call Mexico about a P3 trial.
You actually expect them to do anything on time? Even the FDA is asking them to move faster.
Rookies.... possibly inept.
I appreciate the tip. FDA seems way behind in terms of treatments...
XBIT also needs an international presence.
Leronlimab saves lives and maybe even elections? https://thehill.com/homenews/campaign/513382-trump-approval-on-handling-pandemic-drops-to-31-percent-poll
Trumpy is running out of time... Sunday was a fizzle.
AMERICA wants a shot or a pill... not someone else’s plasma.
Cynically, yes I would’ve thought something would have leaked.
I think offers were on the table but NP is looking for 3x going rate so that kills any mojo that a deal would have. If there was a chance then yes.... it would have crept up like it did on its way to $10.
Now, everyone seems to know that CYDY won’t play ball so it’s best just to let them whither away. NP missed his chance to be a player at the table. Now he has to find another entry point. Until then it’ll hover below $5 based on the science.
It’s not a secret at all... many know what it is in the pipeline.
We’re waiting on the FDA to do what’s right and issue the EUA for leronlimab. Once the P3 is over then they need to issue the approval for the indication.
The Medical community needs to demand leronlimab. That’s how we got the first EINDs at Monte.
No one says they haven’t been bidding. NP price is high, FYI.
Very much so... great point
This sums up my opinions from yesterday fairly well
https://www.newsweek.com/outrageous-trump-announcement-convalescent-plasma-blasted-scientists-1527081
Great. Always nice when government isn’t in the way...
Now it’s up to the public to get leronlimab awareness out there and get this ball rolling. NP can toy with the FDA but he needs a public awareness campaign.
There’s a firefighter in TX that’s about to die because he’s waiting on paperwork for right to try. .... paperwork. Can you imagine if that same firefighter said he needed to see some paperwork before he put out a fire? Hmmm.... BS process.
Paperwork BS is ridiculous... only because of lawyers/litigation.
When lives are at stake you move mountains.
When you search a collapsed building rubble for survivors you don’t wait on paperwork.
Yes. But it’ll be awhile before P3 is filled.
FDA director stood in front of the president and said the drugs in P3 can be used in a right to try if the patients doctor approves.
That’s why public opinion is so important. We need many, many doctors calling FDA daily to get leronlimab and demanding approval based on P2. Government only moves to strong public opinion.
NP strategy to work primarily with FDA puts him at the mercy of BP. He needs grass roots approach.
Yeah, I was joking. Why would the editors review it after publishing it?
Regardless, it’ll be nice to retweet it when done. The publicity will have to push cydy over the finish line. The FDA is 3 months behind it seems. I won’t even get into why they are issuing an EUA on therapies with no clinical trials when they have no EUA with drugs proven with trials. The network medical correspondents are tearing apart the FDA on TV, right fully so.
Was that a pre-print Forbes article? Lol. Seems fishy. Would be nice to have as much top line data in there as well since we are ahead in the race in terms of trials.
It was and Drs are on network news now destroying the FDA narrative. Plasma does NOT have clinical DBP data and they can’t say 35% mortality endpoint improvement without it.
There was a question in the presser asking why drugs in Phase3 can’t be used under a EUA and the FDA said they absolutely could be used if the Dr decided it was best.
What’s that tell us...
1. Idiotz are calling the shots in DC. Lol
2. According to the FDA any doctor can get access to the P3 drug and use it... lol... that’s not true.
Likely because he’s rich. I have no use for Bill and he won’t be able to stop government corruption.
The only force that scares government is aligned public perception.
If I’m Nader I open offices worldwide and have leronlimab fast tracked with countries whose government are accountable to the people (Not the USA). His margins will suffer but at least he’ll get revenue, market share and established data sets proving what is obvious already.
The world has many therapeutics that aren’t approved in the USA... it’s not a new thing.
He can also list CYDY on a Canadian exchange instead of Nasdaq.
NP needs to understand he’s up against very corrupt people who stands to lose a lot.
I agree... I should know by now not to think the US government would be capable of doing anything but destroying countries.
We’ll see, but Gates won’t be they guy. It’ll have to be a chorus of public awareness and maybe even other less corrupt countries using leronlimab first. Then it’ll turn into another “LeronLigate” with politicized public hearings and no accountability.
If it’s plasma then ... it’s clear the government has no idea what they’re doing. That would be sad but true.
More work has to be done by Dr Patterson, Dr Yo, Dr Drew to get public awareness of MOA of Covid and how MaBs work.
5:30 could be a significant letdown for humanity.
Nader in DC yet? LeeeeRawnLeeeeMab.... everyone should practice saying it. Household name soon.
That would be embarrassing for the FDA if it was plasma. It’s not... all arrows pointing to leronlimab right now.
Nah, CYDY just doesn’t know how to deal with the FDA. If they did leronlimab would be easy to bring to market. Lesser drugs get approved.
How do you know they didn’t respond already?
Nice little Dr Drew bump up today. I sure hope NP doesn’t think it was due to his latest ProActive video.
Nothing warp speed about OWS.
Nope. I’m sure it was a very bland uneventful letter
No, OWS doesn’t communicate via snail mail. However, Lower priority items like silly CytoDyn BLA questions need to be submitted in writing.
The UK EUA is likely already denied, NP just left that out and said P3 is a go.
Yep... hope and hype.
Trials are great but cost money... need approvals and revenue. We’re way overpriced for a non revenue company... hope and hype.
That’s why HGEN changed their P3 S2C endpoints.
You still collect it even if the FDA “isn’t” interested.
Someone “like” BP or anyone who understands the MOA would be nice. Too many mistakes ...