Saturday, February 07, 2026 12:19:04 AM
Doc, assume that the original projection for completion of the C unit by mid-year can be met and completed, meeting all of the technical and specifications and requirements in the engineering documents meeting provisional but short of GMP approval. Now assume Powers statement in the ASM re the Flaskworks unit was true, i.e. the original fully functional prototype was developed more than a year prior and met all those machinery operation requirements but still needed to make a GMP version.
If all of this is true (yes, it's a bit of stretch given prior expectations) the Flaskworks machine and the C unit now have to be mated. They need each other to reach GMP approval, machine can't get there unless it's in a GMP unit, the unit can't be approved without a GMP machine installed. Interesting catch-22, but solvable. Once installed, with testing and obtaining regulatory approval, figure another 4-6 months, or late 2026.
If all of this is true (yes, it's a bit of stretch given prior expectations) the Flaskworks machine and the C unit now have to be mated. They need each other to reach GMP approval, machine can't get there unless it's in a GMP unit, the unit can't be approved without a GMP machine installed. Interesting catch-22, but solvable. Once installed, with testing and obtaining regulatory approval, figure another 4-6 months, or late 2026.
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