Well Sherlock, Cytodyn deserved the FDA letter.
The court documents:
Warned for over 1 year of 100+ Hiv-BLA defencies. Warned by FDA how they were not telling that story to shareholders.
Covid hit :
Leronlimab performed miraculously best in the world. Past mgt still chose to stay course on BLA "progress".
FDA rightfully felt mgt was trying to force a Covid approval, so Leronlimab could get embedded. Sweeping the BLA half-truths, under the rug.
Court documents showed that FDA letter went through every head of departments, signed off by legal department.
Two reasons:
1) FDA knew LL worked. Conveniently left out LL was the only FDA approval for hospitals who followed the protocol.
2) It was a warning to any firm that you will have to bring everyone of these FDA heads, into court --- let alone on your own dime.
Govt's too got the message that "somethings not right here" on Cytodyn & knew "Cytodyn" would also put at risk their US Govt dealings.
All worldwide covid deals died.
Dr. Otto's eAP was shut down. No warning.
Told to enroll people into a trial.
Also due to past mgt. using message brds to manipulate the narrative, because 99% retail invest with emotions.
Morals & legalities are oil n water.
That's the short of that.
On 2 vs 4 dosing:
it was me who posted that Dr. J interview source back then. But, i also said you have to listen 1 min longer when Dr. J says he believes the FDA still thought LL was an immunosuppressive.
So did he until right before that meeting --- which he was not a member of --- & said the FDA was not going to take time during a pandemic, to look @ that.
On the FDA E-mail comments about "approval" & Dr. J :
The FDA exchange saying won't even look, before denying. That was due to past mgt causing FDA so many headaches & they took it as trying to bully an approval out of them -- under Covid.
Think about what Tesla initially did after being told by a couple states they could not sell cars in their state.
Tesla pushed ahead asap & became embedded because people were being a vocal support. Tesla gamble paid off.
Similar was Cytodyn's past mgt tactics.
Get covid embedded -- medical community falls in love --- wages public war FOR them later, if post-covid, FDA removed LL.
On FDA e-mail saying Dr. J comes off as a con-man:
They were saying the opposite of what people were ranting about. FDA was saying he's risking his reputation being attached, to a con man, as they were @ that point considering Cytodyn "ceo" to be.
Which ironically, the court documents showed what about that "ceo"? Telling the CRO to submit the incomplete BLA.
Even AFTER the 100 defencies knowledge. Well he's now in fed lock-up. 9 yrs to ponder.
But keep in mind, Dr. J was not an official Cytodyn contact on DSMB meeting. It is why he said he asked DSMB in the hallway (that is a very important legalality right there), if they were seeing signaling needs for 4 doses in later stage Covid patients.
They did not answer him. Dr. Kelly was @ that point in charge.
1 thing everyone never mentioned from all that now backdated chaos is:
1) FDA historically granted Cytodyn many requested designations. Mgt not once, advanced any of them.
Would support an FDA defence they're "holding Cytodyn back @ being in cahoots with pharma".
2) Being Dr. J was not an official of Cytodyn, nothing the FDA referenced about him, was illegal against Cytodyn.
Again, morals Vs legalities.
On "Gilead":
It was me who posted one of our DSMB members also advised Gilead before. I pointed it out because that was around time Cytodyn was to do a LL Vs Remdesevair. Also pointed out to keep in mind --- he was also a highly sought out consultant.
Every company was scratching to compile Safety boards during the pandemic. Ironically, the court documents showed in Dr. J's letter to all those constituents, 1 person was also the mentioned past DSMB member.
If Dr. J felt he was an issue on the 2 Vs 4 dosing, he would not have included him on the CC's, in his personal mail.
Who did Dr. J exclude in his personal e-mail ? The "ceo"
Gilead:
The only "proof" they've held back LL for years, is rooted in all of the above. A very weak attachment that would border on slander.
But again, shareholder emotions that blocks reading patents & documents.
Said all, all of this to say --- ( & there is more, but you get it ).......I won't dig for my posts saying since Dr. J joined January 2024 --- ( although his signature is on Sept 2023 filings), & especially since 1st mTNBC news of 36+ months, that if, if Dr. J & Cytodyn roll this out right, the FDA will not be any issue & Cytodyn could become the most dominant pharma in history.
Patents. Safety. Efficacy. Profit margins. Etc, etc....
Now look our optics post "36+".
Absolutely unfathomable to an imagination.
So the past is why Dr. J ulis going the press release conservative route, for now. It's working too because it's building the Sequencing facts through science data.
So yes, agreed 100% Dr. J has a very stacked approach to be released as Cytodyn continues being recognized for what Leronlimab is.
I was as usual laughed @ & in-directly sarcastic comments when I said:
* LL will break the typical pharma mode of stealing a drug & dominating.
* FDA will not block LL.
Working with Cytodyn in many ways.
* We will later find out the FDA & the DOD have been working with Cytodyn / Dr. J / LL.
I posted days ago of finding so far 5 direct/indirect links of Leronlimab & DOD via people & grant funding. So shall see.
If Cytodyn updates on all trials & the eAP progressions, Cytodyn will have over 10 patient types, collecting Cold/Hot & PD-L1 data, etc...
Becoming more significant than even every fully marketed pharma drug.
Another daym 1st for Leronlimab.
Our only share price "resistance" has been --- awareness.
Yes sir. Cytodyn is now legally sequencing our growth into a pharma powerhouse, through Leronlimab.
: )
The court documents:
Warned for over 1 year of 100+ Hiv-BLA defencies. Warned by FDA how they were not telling that story to shareholders.
Covid hit :
Leronlimab performed miraculously best in the world. Past mgt still chose to stay course on BLA "progress".
FDA rightfully felt mgt was trying to force a Covid approval, so Leronlimab could get embedded. Sweeping the BLA half-truths, under the rug.
Court documents showed that FDA letter went through every head of departments, signed off by legal department.
Two reasons:
1) FDA knew LL worked. Conveniently left out LL was the only FDA approval for hospitals who followed the protocol.
2) It was a warning to any firm that you will have to bring everyone of these FDA heads, into court --- let alone on your own dime.
Govt's too got the message that "somethings not right here" on Cytodyn & knew "Cytodyn" would also put at risk their US Govt dealings.
All worldwide covid deals died.
Dr. Otto's eAP was shut down. No warning.
Told to enroll people into a trial.
Also due to past mgt. using message brds to manipulate the narrative, because 99% retail invest with emotions.
Morals & legalities are oil n water.
That's the short of that.
On 2 vs 4 dosing:
it was me who posted that Dr. J interview source back then. But, i also said you have to listen 1 min longer when Dr. J says he believes the FDA still thought LL was an immunosuppressive.
So did he until right before that meeting --- which he was not a member of --- & said the FDA was not going to take time during a pandemic, to look @ that.
On the FDA E-mail comments about "approval" & Dr. J :
The FDA exchange saying won't even look, before denying. That was due to past mgt causing FDA so many headaches & they took it as trying to bully an approval out of them -- under Covid.
Think about what Tesla initially did after being told by a couple states they could not sell cars in their state.
Tesla pushed ahead asap & became embedded because people were being a vocal support. Tesla gamble paid off.
Similar was Cytodyn's past mgt tactics.
Get covid embedded -- medical community falls in love --- wages public war FOR them later, if post-covid, FDA removed LL.
On FDA e-mail saying Dr. J comes off as a con-man:
They were saying the opposite of what people were ranting about. FDA was saying he's risking his reputation being attached, to a con man, as they were @ that point considering Cytodyn "ceo" to be.
Which ironically, the court documents showed what about that "ceo"? Telling the CRO to submit the incomplete BLA.
Even AFTER the 100 defencies knowledge. Well he's now in fed lock-up. 9 yrs to ponder.
But keep in mind, Dr. J was not an official Cytodyn contact on DSMB meeting. It is why he said he asked DSMB in the hallway (that is a very important legalality right there), if they were seeing signaling needs for 4 doses in later stage Covid patients.
They did not answer him. Dr. Kelly was @ that point in charge.
1 thing everyone never mentioned from all that now backdated chaos is:
1) FDA historically granted Cytodyn many requested designations. Mgt not once, advanced any of them.
Would support an FDA defence they're "holding Cytodyn back @ being in cahoots with pharma".
2) Being Dr. J was not an official of Cytodyn, nothing the FDA referenced about him, was illegal against Cytodyn.
Again, morals Vs legalities.
On "Gilead":
It was me who posted one of our DSMB members also advised Gilead before. I pointed it out because that was around time Cytodyn was to do a LL Vs Remdesevair. Also pointed out to keep in mind --- he was also a highly sought out consultant.
Every company was scratching to compile Safety boards during the pandemic. Ironically, the court documents showed in Dr. J's letter to all those constituents, 1 person was also the mentioned past DSMB member.
If Dr. J felt he was an issue on the 2 Vs 4 dosing, he would not have included him on the CC's, in his personal mail.
Who did Dr. J exclude in his personal e-mail ? The "ceo"
Gilead:
The only "proof" they've held back LL for years, is rooted in all of the above. A very weak attachment that would border on slander.
But again, shareholder emotions that blocks reading patents & documents.
Said all, all of this to say --- ( & there is more, but you get it ).......I won't dig for my posts saying since Dr. J joined January 2024 --- ( although his signature is on Sept 2023 filings), & especially since 1st mTNBC news of 36+ months, that if, if Dr. J & Cytodyn roll this out right, the FDA will not be any issue & Cytodyn could become the most dominant pharma in history.
Patents. Safety. Efficacy. Profit margins. Etc, etc....
Now look our optics post "36+".
Absolutely unfathomable to an imagination.
So the past is why Dr. J ulis going the press release conservative route, for now. It's working too because it's building the Sequencing facts through science data.
So yes, agreed 100% Dr. J has a very stacked approach to be released as Cytodyn continues being recognized for what Leronlimab is.
I was as usual laughed @ & in-directly sarcastic comments when I said:
* LL will break the typical pharma mode of stealing a drug & dominating.
* FDA will not block LL.
Working with Cytodyn in many ways.
* We will later find out the FDA & the DOD have been working with Cytodyn / Dr. J / LL.
I posted days ago of finding so far 5 direct/indirect links of Leronlimab & DOD via people & grant funding. So shall see.
If Cytodyn updates on all trials & the eAP progressions, Cytodyn will have over 10 patient types, collecting Cold/Hot & PD-L1 data, etc...
Becoming more significant than even every fully marketed pharma drug.
Another daym 1st for Leronlimab.
Our only share price "resistance" has been --- awareness.
Yes sir. Cytodyn is now legally sequencing our growth into a pharma powerhouse, through Leronlimab.
: )
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