Tuesday, October 18, 2022 5:44:22 PM
Mav,
You may be very right, the only way that we could be closer than people believe would be if CRL is readying production facilities in spite of that not being announced. I simply don't know if that's possible, or not. As I see it, hundreds or thousands of the FlaskWorks units can be built, if the facilities for utilizing them are built, the installation itself ought to be simple, something like adding a printer or computer to an existing network. The question is, has the FDA and/or other regulators accepted the FlaskWorks units for commercial production, perhaps in an informal way that wouldn't be announced, already.
As I understand it, the commercial manufacturing approval is part of the BLA filing for the FDA, and perhaps all but the U.K. If that's the case, and if CRL is ready to receive the FlaskWorks units, it's possible for things to come together quite rapidly.
Gary
You may be very right, the only way that we could be closer than people believe would be if CRL is readying production facilities in spite of that not being announced. I simply don't know if that's possible, or not. As I see it, hundreds or thousands of the FlaskWorks units can be built, if the facilities for utilizing them are built, the installation itself ought to be simple, something like adding a printer or computer to an existing network. The question is, has the FDA and/or other regulators accepted the FlaskWorks units for commercial production, perhaps in an informal way that wouldn't be announced, already.
As I understand it, the commercial manufacturing approval is part of the BLA filing for the FDA, and perhaps all but the U.K. If that's the case, and if CRL is ready to receive the FlaskWorks units, it's possible for things to come together quite rapidly.
Gary
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