Two to three weeks silence - why? Here is my take
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Posted On: 03/04/2021 2:11:42 PM
Two to three weeks silence - why? Here is my take on this.
I believe the FDA, at the very least, is working on an EUA document, much like the one they generated for Bamlanivimab -
https://www.fda.gov/media/144118/download
I am surprised that Cytodyn has not put out a press release saying that they have applied for an EUA and yet I believe the FDA is indeed working on such a document which must be completed before an EUA can be granted. Perhaps the FDA told Cytodyn they didn't have to make the request formally or not yet.
Bamlanivimab got an EUA without even finishing their drug trials! DARPA, of all outfits, was pushing for that as well as Eli Lilly and they worked thru the CTAP program. BARDA was involved too I believe.
The FDA working on an EUA document makes sense tho because it is a rather exhaustive document, the kind that would take even smart people 2 or 3 weeks to produce, and they would have to produce an almost redundant document for the approval of Leronlimab anyway which is normally done after the company submits a top-line report on drug trial results. FDA just took the raw data and set to work, in my opinion!
Yes, I do think the FDA set the 2 or 3 week timeline for part of the news we are awaiting. I have no idea how long CDER takes to do their part towards drug approval but perhaps that work is proceeding in parallel to the other FDA work. I certainly hope that is so. It would show haste on the FDA's part which is quite out of the ordinary.
Company silence, I hope, means Cytodyn is focusing a lot of their resources towards ensuring the FDA gets everything they need to do their paperwork and info vetting on manufacturing, distribution and safety. They have to do the same with the FDAs of other countries too, perhaps more than with just England and Canada.
I do expect that when the silence is broken, Cytodyn will have a boatload of things to tell us, probably all of them good to fantastic, and I don't begrudge anyone the time to do things right!
Me, I think I can twiddle my thumbs right.
Check out the CTAP front page while you are waiting. I like the scoreboard altho it is out of date. Just shows how desperate the situation is.
https://www.fda.gov/drugs/coronavirus-covid-1...ogram-ctap
Note the number of immunomodulators being investigated even tho they are rarely mentioned by FDA.
I believe the FDA, at the very least, is working on an EUA document, much like the one they generated for Bamlanivimab -
https://www.fda.gov/media/144118/download
I am surprised that Cytodyn has not put out a press release saying that they have applied for an EUA and yet I believe the FDA is indeed working on such a document which must be completed before an EUA can be granted. Perhaps the FDA told Cytodyn they didn't have to make the request formally or not yet.
Bamlanivimab got an EUA without even finishing their drug trials! DARPA, of all outfits, was pushing for that as well as Eli Lilly and they worked thru the CTAP program. BARDA was involved too I believe.
The FDA working on an EUA document makes sense tho because it is a rather exhaustive document, the kind that would take even smart people 2 or 3 weeks to produce, and they would have to produce an almost redundant document for the approval of Leronlimab anyway which is normally done after the company submits a top-line report on drug trial results. FDA just took the raw data and set to work, in my opinion!
Yes, I do think the FDA set the 2 or 3 week timeline for part of the news we are awaiting. I have no idea how long CDER takes to do their part towards drug approval but perhaps that work is proceeding in parallel to the other FDA work. I certainly hope that is so. It would show haste on the FDA's part which is quite out of the ordinary.
Company silence, I hope, means Cytodyn is focusing a lot of their resources towards ensuring the FDA gets everything they need to do their paperwork and info vetting on manufacturing, distribution and safety. They have to do the same with the FDAs of other countries too, perhaps more than with just England and Canada.
I do expect that when the silence is broken, Cytodyn will have a boatload of things to tell us, probably all of them good to fantastic, and I don't begrudge anyone the time to do things right!
Me, I think I can twiddle my thumbs right.
Check out the CTAP front page while you are waiting. I like the scoreboard altho it is out of date. Just shows how desperate the situation is.
https://www.fda.gov/drugs/coronavirus-covid-1...ogram-ctap
Note the number of immunomodulators being investigated even tho they are rarely mentioned by FDA.
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