Yes thank you. I couldn't wait and actually just s
Post# of 154852
(Total Views: 567)
Posted On: 03/08/2021 9:09:43 PM
Re: nmbr1stckpckr #82129
Yes thank you. I couldn't wait and actually just skipped around to find talk in today's call regarding this. This is the full statement from Nader today in response to what I was wondering in my earlier post.
"I was told last night that Chiral Pharmaceutical...is ready to file CSP as of last night (perhaps they have done it, I haven't gotten confirmation) because they have received from hospitals indication of wanting to get Leronlimab for certain patients. As soon as this is filed (if it hasn't been already filed) it will take 48 hours for us to get clearance. Chiral Pharmaceutical has told us that there FDA has said that the CSP will be given when they file but we still don't have it yet but once they get it we will send them vials of Leronlimab immediately for immediate sales to the patients. This will start will a very small number of patients but if we get some good results they have told us that Emergency Use Authorization along with CD12 data we have could be possible."
Glad to hear this. Sounds like we have a pretty cool accomplishment happening in the short-term. Sounds like a CSP is like a mini-EUA. The day this company can say they've made their first sale is a worthy accomplishment and something that we can say came from the efforts of CD10/12. I can hold my breathe for this and will be happy when the PR is released, hopefully this month.
Another thing from the call today:
"[Cytodyn team] all believe the results are very strong to warrant conditional EUA while we generate more data. So we are working on all avenues for this conditional EUA while we conduct small 140 patient trial."
I won't be holding my breathe for this. However, glad to see Nader is looking to "fight back" in a sense. Something I've been hoping to see from Nader for some time. I understand that we must play nice with the FDA but cmon we gotta stand for ourselves a little and demand some respect.
GLTA
"I was told last night that Chiral Pharmaceutical...is ready to file CSP as of last night (perhaps they have done it, I haven't gotten confirmation) because they have received from hospitals indication of wanting to get Leronlimab for certain patients. As soon as this is filed (if it hasn't been already filed) it will take 48 hours for us to get clearance. Chiral Pharmaceutical has told us that there FDA has said that the CSP will be given when they file but we still don't have it yet but once they get it we will send them vials of Leronlimab immediately for immediate sales to the patients. This will start will a very small number of patients but if we get some good results they have told us that Emergency Use Authorization along with CD12 data we have could be possible."
Glad to hear this. Sounds like we have a pretty cool accomplishment happening in the short-term. Sounds like a CSP is like a mini-EUA. The day this company can say they've made their first sale is a worthy accomplishment and something that we can say came from the efforts of CD10/12. I can hold my breathe for this and will be happy when the PR is released, hopefully this month.
Another thing from the call today:
"[Cytodyn team] all believe the results are very strong to warrant conditional EUA while we generate more data. So we are working on all avenues for this conditional EUA while we conduct small 140 patient trial."
I won't be holding my breathe for this. However, glad to see Nader is looking to "fight back" in a sense. Something I've been hoping to see from Nader for some time. I understand that we must play nice with the FDA but cmon we gotta stand for ourselves a little and demand some respect.
GLTA
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