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Read this: https://www.outlookindia.com/newsscroll/working-to-increase-production-capacity-of-actemra-roche/2073018
Tocolizumab failed not hitting any of their PE, SE for their PH3. Yet, it's increased demand (some Dr's are still prescribing it).
LL has obviously done a PH3 and with the new topline report out and the 'hypothetical' thesis [as the FDA puts it] of 4 doses, it gives me hope that EUA from India may come faster than the Philippines. If I recall correctly, on either Lalezari interview or the CC, there was a drug that was granted EUA while doing a very very small sized trial.
This is all my opinion. Fact is, India is in bad shape. Meds aren't getting to them fast enough..
GLTU/A.
BoruFD - glad to have you aboard the CYDY train. Those papers losses will turn green in due time. No doubt about that, IMHO.
GLTU/A.
DBOT - "Could India grant EUA from those results?" -- I'm hoping they grant EUA while doing a small trial (similar to toculizamab).
Lets hope so as now they see the useless drugs that don't help COVID (remdeath, toc, plasma)..
GLTU/A
d0lphint0m -- sorry to hear about this.. very sad.
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Timing. You as a shareholder should know we just signed an exclusive 3 year deal with MacLeods in India.
Great timing right?
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misiu143 - "In Brazil study will be with 4 weeks of treatment , and even possible first dose IV , this will be perfect.
Results should be excellent."
MONEY IN THE BANK, IMHO.
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"Headquartered in the USA, made in Korea by Samsung Biologics and sold worldwide except the United States. " -- nice, thanks for the correction! :thumbsup emoji:
GLTU/A.
"Cytodyns biggest antagonism to the FDA is having a drug that works better than those put out by BP, but the FDA closed minds do not understand how it works and dont want to be open so they just go with "it doesnt work"" -- made in the USA. Sold outside of it.
I'm OK with that.
GLTU/A.
Yes - I got an email from her regarding 10-K not 23 hours ago. Why do you ask?
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MelsDollars - "Their trial was combined into a phase 2b/3, "all or nothing" shot, at a time when little was known about the disease. " I can always appreciate anyone or team that swings for the fences.
GO big or GO home right?
GLTU/A.
misiu143 - "So it was a little of fresh air to noticed these doctors are not afraid of Gilead and US FDA , and giving honest opinion about remdesivir.." -- this is what still gives me hope that LL still has a very very good chance outside the web of nonsense here.
SP down, morale down, arguing amongst the shareholders..
What happens when you have so much pressure exerted to piece of useless coal? That's right. DIAMONDS.
GLTU/A.
What goes around comes around:
"What I feel bad is - NP wasted a very good product"
Why is your statement past tense like the company is out of business?
"- Kelly and him should be kicked out and some good professional CEO should be brought in"
Both you and BlackOps - would like to hear your thoughts on how to make this happen as you've piqued my curiousity.
GLTU/A.
100% agree with you dolphinTom. Collectively, we may own a percentage of the total shares but pales in comparison to those that hold 8, 9 digits.
We'll get there.. just on NP's time.
GLTU/A.
Damn good thing we have Cito reporting and Dr. Nichols paving the way. Plus that 1 hour special TV special last week.
With that being said, 1 closed door, opens another..
Lets see where this goes in 3-4 months. I for one can say 2 things realized from the call which is for once (maybe twice), NP was being real. Team seems tired. Literally exhausted. The second is that there is firm conviction that it's 4 doses from here on out at 700mg. I'm very very very glad to have Dr. Gaylis as the mundane, classic critical thinker that he is. We are lucky to have him on board.
GLTU/A.
I'm not going to pretend that I don't like the volume but today will make it in the top 10 this year (6/30/2020 being the biggest by far). Eerily similar to 11/10/2020 where we closed at 1.99. This would be the 3rd time this stock has reached this near bottom. Has all capitulation been done and we start rising (once again)? Lets damn hope so..
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Nice one mightyCYDY, thanks for posting this and welcome the board!
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The RESOLVE of a long CYDY shareholders is quite 'extraordinary' as the polysci-turned blogger put it, isn't it? I for one, am impressed.
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Oh boy.. you may be on to something between CYDY and our favorite DSMC person: https://stocktwits.com/Bio4/message/331874517
Interesting...
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Does anyone know if they found the lead plaintiff for the 12 or so very prestigious law firms that were sending out PR's non-stop for the past 90 days against CYDY? Asking for a friend.
GLTU/A.
Some info from Arian regarding the 200K vials each PR has. I asked it to be answered during today's CC but she answered right away:
Question: Why are we limiting only 200K for the other countries? It's obviously clear FDA wants a P value, pandemic/endemic or not. Why aren't we doing first come first serve? Please explain that rationale.
Answer:
"
Cydy Team
4:42 AM (4 hours ago)
to me
We have not limited 200K to each country. I believe we have committed our entire inventory subject to approval.
"
WE JUST NEED PHILIPPINES OR INDIA OR BRAZIL OR CANADA TO GIVE US EUA. THEN OUR INVENTORY will be sold.
Hopefully this clears up a question anyone else had regarding the 200K vial quantity.
GLTU/A.
Grip - I always like and read your opinions but '$1 by the end of the week! ' ? Under what basis? Please don't say technicals because no one would have predicted that BS from yesterday. I'd really like to hear this one..
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Covid was a bonus (in terms of SP). WE'VE HIT THE "MAGIC" FDA NUMBER WITH HIV. That can't take out a newsletter for that (can they?) Just need to submit it correctly, the SP will take care of itself. This IMHO will 'hold' the company while other things like LH and Basket, etc. Obviously even during a pandemic where millions are dying world wide, the stoic FDA needs that number. <= .005. not .0051, .005 or less.
GLTU/A.
8-K Out: https://ir.stockpr.com/cytodyn/sec-filings-email/content/0001193125-21-163831/d185044d8k.htm
Sell 200K to Philippines
Sell 200K to Brazl.
Leave the rest to India.
Fine with that.
GLTU/A.
IMHO - this keeps new investors and speculators out. Shake even the half-hearted long that was in the stock for some time. This keeps the market cap low and maybe sustained.
I have a lot invested and am willing to go down with the molecule if needs be. I think something in the works. I really hope I'm right.
GLTU/A.
"It would be even worse for the FDA if they said nothing. They are giving themselves a fall back statement when the backlash occurs at the conclusion. " - I'm on an public FDA email list that I've subscribed to. This didn't come down normal channels, else I would have been alerted. CYA is, IMHO, what they are doing. 100%.
MC is SO low compared to how close we are to the end goal (Brazil, India, LH)
Damn me to think a B/O is right around corner...
All my OWN opinion.
GLTU/A.
SF Anony - damn good post. Very very real.
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You forgot, the last day of the bogus lawsuits too. Coincidence? During market hours, in the last trading hour? Hmm..
Great price to buy a ton of shares for much less than their worth by..??
GLTU/A.
Exactly. They NEED a P VALUE at or below 0.05. Live and die by that number. Literally. Sad.
GLTU/A.
"To say this is old news is being in complete denial." Complete denial of what? We knew they knew. Which is why we're moving to CD16/17 in Brazil with a better trial setup.
I 100000% agree with you on this: "For the FDA to make a public announcement about a product that doesn't have a single purchase order is nothing short of extraordinary. There must be an underlying reason for them to take this action, especially during market hours."
GLTU/A.
This won't be the first time the FDA retraces their steps. It certainly won't be the last.
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I also see this event has: If this didn't shake weak hands, nothing will.
Believe me when I say I'd rather see this in the 4+. Never would I have thought we'd see this in the $1's again.
GLTU/A.
Or you buy CYDY when it's a 5 for 1 sale. Remember, when bulls see red.. they charge.
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LOL - at this moment, I'll take anything. Never thought we'd see $1's again. WOW.
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https://www.fda.gov/drugs/drug-safety-and-availability/statement-leronlimab
Not a short attack.
Interesting line from FDA:
"However, as noted above, such analyses may inform the design of future clinical trials investigating leronlimab for the treatment of COVID-19.
If CytoDyn plans further studies of leronlimab to determine whether the drug can provide clinical benefit to individuals with COVID-19, FDA will continue to provide advice to the company on their development program.
FDA recognizes the critical unmet medical need for new, effective treatments for COVID-19, especially for severe forms of the disease. We are committed to working with sponsors of novel therapies to facilitate development and approval of new treatments."
I believe this may be due to public outcry to get LL to be approved from LL and this was their 'official' public response.
GLTU/A.
Great post and I like the declarative statements made regarding CYDY.
Keep them coming jbl200.
GLTU/A.
Interesting FDA news: https://www.fda.gov/news-events/press-announcements/fda-brief-fda-provides-guidance-master-protocols-evaluating-prevention-treatment-options-covid-19
How would this impact CYDY?
GLTU/A.
Both true statements. You missed a few things though:
1. It is the most effective against Severe and critical sub pop. Dispute me on this, I'd like to see logic / links.
2. We're in a pandemic. We will be for some time..
GLTU/A.