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Posted On: 11/29/2023 8:50:55 PM
Post# of 148870
Not trying to over-whiz, but the thing transferred could be a master or primary contract to produce LL, releasing Samsung from same, instead of the transferring of intellectual property to make manufacturing possible.
Only the FDA can approve the CMC portions of a BLA. Which AGC already has obtained within Cytodyn’s domain.
Could be a huge new partner… but manufacturing protocols would take time. Remember when Nitya Ray and FDA got that done with full inspections of the manufacturing facilities in 2018….in KOREA?
Hopefully everything is coming together for a big partner or buyout. This part doesn’t necessarily indicate this for me.
It does however bear mentioning in lifting of the partial HIV hold, and the new HIV protocol request the FDA made of us. I reckon that we’d need an approved manufacturer of our product in order to get a protocol approved, depending on quality of current viable stocks, and size of studies (=n over time, potential EUA’s, existing patients, and KOLs etc) It may be that all of this fits into satisfying that big FDA goalpost thing.
Only the FDA can approve the CMC portions of a BLA. Which AGC already has obtained within Cytodyn’s domain.
Could be a huge new partner… but manufacturing protocols would take time. Remember when Nitya Ray and FDA got that done with full inspections of the manufacturing facilities in 2018….in KOREA?
Hopefully everything is coming together for a big partner or buyout. This part doesn’t necessarily indicate this for me.
It does however bear mentioning in lifting of the partial HIV hold, and the new HIV protocol request the FDA made of us. I reckon that we’d need an approved manufacturer of our product in order to get a protocol approved, depending on quality of current viable stocks, and size of studies (=n over time, potential EUA’s, existing patients, and KOLs etc) It may be that all of this fits into satisfying that big FDA goalpost thing.
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