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Posted On: 10/21/2020 12:40:20 AM
Post# of 148902
What I heard in the CC that was most exciting to me was that Cytodyn was talking to OWS. Pourhassen confirmed it by saying he couldn't talk about it.
If Cytodyn is talking to OWS, they are talking to Dr. Janet Woodcock who is in charge of Covid-19 therapeutics. If our data gets to her desk, my bet is she is going to say, "WOW... This is exactly what I am in business to find! Cytodyn, we have ordered billions of dollars of unproven vaccines from outfits like Regeneron... It seems only fair that I recommend the purchase of a boatload of Leronlimab from you "just in case" you prove efficacy in your next Interim Review!"
Such is the power she has through OWS.
Then remember that, before the Pandemic, she was the head of CDER at FDA (Center for Drug Evaluation and Research), the next department to determine Leronlimab's fate. CDER's job is to perform "an essential public health task by making sure that safe and effective drugs are AVAILABLE to improve the health of people in the United States."
It vets manufacturing in both quality and QUANTITY!
I said months ago (https://investorshangout.com/post/view?id=5816733) that approval can be held up by supply concerns by the FDA. Woodcock confirmed this in the video I posted a link to -
https://www.cnbc.com/video/2020/10/15/healthy...dcock.html
Thankfully, NP has confirmed supply is beginning to flow but only beginning.
CDER is also the department that grants BLAs and then is in charge of monitoring marketing and after-approval drug safety.
It very well may be possible that Cytodyn is given an order for many millions of doses of Leronlimab even before the next Interium Review - you know, just in case it WORKS!
That is my hope. I dream about what news like that would do to the share price....WOW!
If Cytodyn is talking to OWS, they are talking to Dr. Janet Woodcock who is in charge of Covid-19 therapeutics. If our data gets to her desk, my bet is she is going to say, "WOW... This is exactly what I am in business to find! Cytodyn, we have ordered billions of dollars of unproven vaccines from outfits like Regeneron... It seems only fair that I recommend the purchase of a boatload of Leronlimab from you "just in case" you prove efficacy in your next Interim Review!"
Such is the power she has through OWS.
Then remember that, before the Pandemic, she was the head of CDER at FDA (Center for Drug Evaluation and Research), the next department to determine Leronlimab's fate. CDER's job is to perform "an essential public health task by making sure that safe and effective drugs are AVAILABLE to improve the health of people in the United States."
It vets manufacturing in both quality and QUANTITY!
I said months ago (https://investorshangout.com/post/view?id=5816733) that approval can be held up by supply concerns by the FDA. Woodcock confirmed this in the video I posted a link to -
https://www.cnbc.com/video/2020/10/15/healthy...dcock.html
Thankfully, NP has confirmed supply is beginning to flow but only beginning.
CDER is also the department that grants BLAs and then is in charge of monitoring marketing and after-approval drug safety.
It very well may be possible that Cytodyn is given an order for many millions of doses of Leronlimab even before the next Interium Review - you know, just in case it WORKS!
That is my hope. I dream about what news like that would do to the share price....WOW!
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