BLA, I brought it up before. Again not pushing
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Posted On: 06/21/2020 7:10:36 PM
BLA,
I brought it up before. Again not pushing IBIO or any other. At that time, as well as this, I believe we have a worldwide shortage for our product. This may have led to slow walking our approvals and Presidential task force pronouncements . Etc.
The result then was a few folks responded that the FDA needs 2-3 trial runs in the specific manufacturing procedures at same facility and this kind of idea wouldn’t be feasible. I get that. As it should be.
Other ideas to get to 100s of millions of doses are definitely appreciated. Not pushing this.
I do believe this method can reproduce monoclonal antibodies.
My main question, or point, is how do we get to new heights of production as needed. 6 million by 2021 is a start for Worldwide need, but possibly insufficient.
2-3 FDA oversight trial runs at additional outside- of-the-box manufacturers, might be possible in that kind of timeline.
Any creative ideas to get there work for me. I may partial as a North Carolina boy. If we can bioreact Leronlimab in a derivative of the Tobacco plant? And just grow more plants as needed? Well, my circle is closed.
I brought it up before. Again not pushing IBIO or any other. At that time, as well as this, I believe we have a worldwide shortage for our product. This may have led to slow walking our approvals and Presidential task force pronouncements . Etc.
The result then was a few folks responded that the FDA needs 2-3 trial runs in the specific manufacturing procedures at same facility and this kind of idea wouldn’t be feasible. I get that. As it should be.
Other ideas to get to 100s of millions of doses are definitely appreciated. Not pushing this.
I do believe this method can reproduce monoclonal antibodies.
My main question, or point, is how do we get to new heights of production as needed. 6 million by 2021 is a start for Worldwide need, but possibly insufficient.
2-3 FDA oversight trial runs at additional outside- of-the-box manufacturers, might be possible in that kind of timeline.
Any creative ideas to get there work for me. I may partial as a North Carolina boy. If we can bioreact Leronlimab in a derivative of the Tobacco plant? And just grow more plants as needed? Well, my circle is closed.
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