(Total Views: 717)
Posted On: 09/07/2020 12:34:52 PM
Post# of 154912
Great post, Sent108. I have been thinking in similar ways, with this added "theory."
It has never made sense to me that FDA could approve Leronlimab for Covid without getting a full BLA submission on Leronlimab for something. Without that, they wouldn't have any grounds for knowing that the Manufacturing processes were up to standards.
Obviously, they know that things are "good enough" for trials and a lot of EIND tests. But, that is different than an approval.
So, getting the HIV BLA squared away could very much be a way of covering the bases for a full approval. As Cdiddy just posted, Covid could be deemed a label expansion to the HIV approval. (And, a COVID EUA could be an interim step).
Said another way, without the full and complete HIV package, it seems like the FDA would be required to ask CYDY to submit a BLA for Covid in order to get to our first full approval.
It has never made sense to me that FDA could approve Leronlimab for Covid without getting a full BLA submission on Leronlimab for something. Without that, they wouldn't have any grounds for knowing that the Manufacturing processes were up to standards.
Obviously, they know that things are "good enough" for trials and a lot of EIND tests. But, that is different than an approval.
So, getting the HIV BLA squared away could very much be a way of covering the bases for a full approval. As Cdiddy just posted, Covid could be deemed a label expansion to the HIV approval. (And, a COVID EUA could be an interim step).
Said another way, without the full and complete HIV package, it seems like the FDA would be required to ask CYDY to submit a BLA for Covid in order to get to our first full approval.
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