I am surprised that so many people are having a hard time teasing out the meaning of yesterday's PR from Cytodyn. It was an excellent PR by all implications.
This was simply an announcement of the unblinding of the data and the data being forwarded on in its raw form to the FDA, MHRA and Health Canada. This evidently immediately led to discussions with these agencies on how to proceed to eventual approval and use of Virologix. There is no question of drug failure here!
Expecting an announcement of top line results before the writing of a Top Line Report would be ridiculous! Any stock exchange would see this as an attempt at stock price manipulation! That would not go well for the company involved, especially for one wanting to be listed on another exchange!
There has been virtually no discussion on this board of the steps a company has to take with the FDA after it has jumped thru the hoops of drug trials. What next? Not just in this country but in other countries.
I sincerely hope Cytodyn essentially ties in to the CTAP program. Here is what that means -
https://www.fda.gov/news-events/fda-voices/up...on-program
Point after point in this short article applies to Cytodyn and Virologix. CTAP is for therapeutics, not vaccines. CDER considers all after-trial aspects of getting a successful drug to market normally and issuance of an EUA.
However, these are not normal times. Cytodyn also could use the help offered by OWS which was for public-private development partnerships. Above all, it offered funding for manufacturing and large purchase orders of the drugs involved. Cytodyn did not opt for any government help that had strings attached.
But Cytodyn desperately needs help to meet the demands for Virologix and the government knows this.
As I have said before, I believe FDA approval for Virologix is a done deal, at least for use in S/C cases. The rest is all LOGISTICS.
Hopefully as the FDA and Cytodyn engage in discussions, the FDA will come to realize how fantastic Leronlimab is.
When you pick up the HAMMER of Leronlimab, a lot of pathologies do indeed look like nails!
If they want to look at mortality after 28 days, fine! Now you are talking Long Haulers because the virus is long gone if Leronlimab restored the CD8 T-cell population. All virus should be gone, unless dexamethasone suppressed the immune system and allowed the virus to find a safe harbor somewhere in the body! Not Leronlimab's fault! Approve Virologix for Long Haulers NOW!
Hopefully, sooner rather than later, there will be a whole division of the FDA dedicated to facilitating the many uses for Leronlimab. They are going to need it! Drug agencies in other countries better gear up too.
The HAMMER OF LERONLIMAB is going to give the Hammer of Thor some competition! (IMO.)
This was simply an announcement of the unblinding of the data and the data being forwarded on in its raw form to the FDA, MHRA and Health Canada. This evidently immediately led to discussions with these agencies on how to proceed to eventual approval and use of Virologix. There is no question of drug failure here!
Expecting an announcement of top line results before the writing of a Top Line Report would be ridiculous! Any stock exchange would see this as an attempt at stock price manipulation! That would not go well for the company involved, especially for one wanting to be listed on another exchange!
There has been virtually no discussion on this board of the steps a company has to take with the FDA after it has jumped thru the hoops of drug trials. What next? Not just in this country but in other countries.
I sincerely hope Cytodyn essentially ties in to the CTAP program. Here is what that means -
https://www.fda.gov/news-events/fda-voices/up...on-program
Point after point in this short article applies to Cytodyn and Virologix. CTAP is for therapeutics, not vaccines. CDER considers all after-trial aspects of getting a successful drug to market normally and issuance of an EUA.
However, these are not normal times. Cytodyn also could use the help offered by OWS which was for public-private development partnerships. Above all, it offered funding for manufacturing and large purchase orders of the drugs involved. Cytodyn did not opt for any government help that had strings attached.
But Cytodyn desperately needs help to meet the demands for Virologix and the government knows this.
As I have said before, I believe FDA approval for Virologix is a done deal, at least for use in S/C cases. The rest is all LOGISTICS.
Hopefully as the FDA and Cytodyn engage in discussions, the FDA will come to realize how fantastic Leronlimab is.
When you pick up the HAMMER of Leronlimab, a lot of pathologies do indeed look like nails!
If they want to look at mortality after 28 days, fine! Now you are talking Long Haulers because the virus is long gone if Leronlimab restored the CD8 T-cell population. All virus should be gone, unless dexamethasone suppressed the immune system and allowed the virus to find a safe harbor somewhere in the body! Not Leronlimab's fault! Approve Virologix for Long Haulers NOW!
Hopefully, sooner rather than later, there will be a whole division of the FDA dedicated to facilitating the many uses for Leronlimab. They are going to need it! Drug agencies in other countries better gear up too.
The HAMMER OF LERONLIMAB is going to give the Hammer of Thor some competition! (IMO.)
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