Flaskworks is being validated. It’s part of their expansion plan. I disagree that it all has to be immediately available and in fact the evidence of relevant approvals says otherwise, specifically Car-T firms. They are not going to withhold approval where they gave it before, especially when the new company has the technology to scale up with automation. The fact is you need a plan to scale at this time, that plan may need a certain degree of reality. They may, for instance, need a facility from a financial provider that they will assist upon approval. That might not be public, and contingent, but the kinds of reassurances a regulator might require might be to ensure that the plans are adequately concrete to be a realistic likelihood rather than a current reality.
And otherwise, they would not have gone down this path for decades if they never had a chance of approval but for an unforeseen opportunity to buy a company called Flaskworks. Nor would a regulator have required that they buy from a specific supplier to be approved. These are false ideas that people post because they do not understand and they sound smarter saying these things. But these are not real requirements.
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