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Posted On: 07/06/2020 2:40:04 PM
Post# of 156105
I remember hearing that Samsung had other facilities with identical setups and identical bioreactors -- but that they were not approved by the FDA.
Also, AGC just purchased an enormous facility in Boulder, CO -- but that too has not been approved by the FDA.
I don't know what forces can be brought-to-bear to increase this capacity limitation if we are approved. However, we also need to recognize that the FDA might have more stringent requirements than other parts of the world for new facilities to be approved.
And if that were to be the case, maybe additional production destined for ex-US locations can happen with less latency.
Take a look at this video excerpt to get confirmation of the approval time frame:
Video Excerpt Link: https://youtu.be/WiyjIIpkIJw?t=1811
Also, AGC just purchased an enormous facility in Boulder, CO -- but that too has not been approved by the FDA.
I don't know what forces can be brought-to-bear to increase this capacity limitation if we are approved. However, we also need to recognize that the FDA might have more stringent requirements than other parts of the world for new facilities to be approved.
And if that were to be the case, maybe additional production destined for ex-US locations can happen with less latency.
Take a look at this video excerpt to get confirmation of the approval time frame:
Video Excerpt Link: https://youtu.be/WiyjIIpkIJw?t=1811
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