Nader states Recknor got the HIV BLA back on track; the FDA reviewed the Dose Justification Report AND Receptor Occupancy. It looks ok. There just needs to be small adjustments to what seems almost fully file-able. The company is STILL aiming for October 15th.
Like I said before this is BIG because: “THIS Receptor (occupancy) isn’t just for HIV”
This receptor occupancy can likely be used for all the possible indications we are actively pursuing. This is important and I’ll tell you why. (Besides that it helps expedite all filings).
When a company submits an FDA Biological License Application, they have to demonstrate:
Safety, Purity, Potency:
“An application for a biologics license shall not be considered as filed until all pertinent information and data have been received by the Food and Drug Administration.”
21 C.F.R. 601.2
The company is turning in our cd10 and cd 12 Manuscripts: Why?
CD10 (moderate) had 64% less severe adverse effects.
CD12 (severe/critical) had 21% less adverse effects.
And we all know about 82% efficacy in cd12.
This helps gather and document data before the Brazil trials even start (or finish if they haven’t started already).
This helps the clinics and non-clinical entries in the future.
To put it in simple terms:
The FDA is already potentially agreeing with CytoDyn on the format and contents of any BLA filing based on safety of 350Mg, 525Mg, 700mg dose justification and receptor occupancy.
Now read this quote again:
“We have a great molecule with many opportunities being evaluated in parallel to the BLA, including COVID, NASH and Oncology.” -Recknor
As someone stated, the Brazil trials are ON the FDA clinical trials list as recognizable because of this. I.e the US FDA meetings with ANVISA recently was for a reason. It was on their website, but of course I watched zero 13D supporters say that. Because their priority isn’t advancing Leronlimab, it’s bashing management and creating FUD.
To recap: We learned that no one turned in the receptor occupancy correctly before.
Recknor has found out more about the MOA of LL than anyone in the last 10 years.
So, Why are they opposing CytoDyns motion to expedite discovery and cross-motion … to dismiss CytoDyns complaints?
Their first responses was childish. They didn’t fess up to all accusations. (They conveniently left out the 350M / total).
They tried to make one of the top Law firms look ridiculously dumb by stating they filed everything correctly.
Then proceeded to re-file because the lies they were caught in needed to be stated.
And then they went to ask for dismissal, because they re-filed it.
Is anyone a parent here? When you catch your child in a lie do you say it’s ok since you only told the truth ONLY after I caught you, or do you find a way of reprimanding anyway? I would reprimand because I know that my child’s actions and initial intent was likely harmful to others from making an educated decision. Punishment isn’t necessarily the goal; telling the full truth is, and we don’t know we have it all in truth yet. What’s to hide?
Like I said before this is BIG because: “THIS Receptor (occupancy) isn’t just for HIV”
This receptor occupancy can likely be used for all the possible indications we are actively pursuing. This is important and I’ll tell you why. (Besides that it helps expedite all filings).
When a company submits an FDA Biological License Application, they have to demonstrate:
Safety, Purity, Potency:
“An application for a biologics license shall not be considered as filed until all pertinent information and data have been received by the Food and Drug Administration.”
21 C.F.R. 601.2
The company is turning in our cd10 and cd 12 Manuscripts: Why?
CD10 (moderate) had 64% less severe adverse effects.
CD12 (severe/critical) had 21% less adverse effects.
And we all know about 82% efficacy in cd12.
This helps gather and document data before the Brazil trials even start (or finish if they haven’t started already).
This helps the clinics and non-clinical entries in the future.
To put it in simple terms:
The FDA is already potentially agreeing with CytoDyn on the format and contents of any BLA filing based on safety of 350Mg, 525Mg, 700mg dose justification and receptor occupancy.
Now read this quote again:
“We have a great molecule with many opportunities being evaluated in parallel to the BLA, including COVID, NASH and Oncology.” -Recknor
As someone stated, the Brazil trials are ON the FDA clinical trials list as recognizable because of this. I.e the US FDA meetings with ANVISA recently was for a reason. It was on their website, but of course I watched zero 13D supporters say that. Because their priority isn’t advancing Leronlimab, it’s bashing management and creating FUD.
To recap: We learned that no one turned in the receptor occupancy correctly before.
Recknor has found out more about the MOA of LL than anyone in the last 10 years.
So, Why are they opposing CytoDyns motion to expedite discovery and cross-motion … to dismiss CytoDyns complaints?
Their first responses was childish. They didn’t fess up to all accusations. (They conveniently left out the 350M / total).
They tried to make one of the top Law firms look ridiculously dumb by stating they filed everything correctly.
Then proceeded to re-file because the lies they were caught in needed to be stated.
And then they went to ask for dismissal, because they re-filed it.
Is anyone a parent here? When you catch your child in a lie do you say it’s ok since you only told the truth ONLY after I caught you, or do you find a way of reprimanding anyway? I would reprimand because I know that my child’s actions and initial intent was likely harmful to others from making an educated decision. Punishment isn’t necessarily the goal; telling the full truth is, and we don’t know we have it all in truth yet. What’s to hide?
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