They are not at that stage and the importance is a practical capacity/capability to manufacture and an expansion plan. The FDA is not telling them not to release TLD because they don’t own a plant in the US. Many of those details get worked out in the lead up to the application, and they have all the practical details lined up already. Expanding production into the US for these tiny companies can come through partnership or acquisition, and the FDA does not require that they sell themselves before they will approve a plan. But they need a workable and viable plan that can show for the necessity of Accelerated Approval, they could be able to scale up to meet the requirements if they were the new SOC. That is the point of accelerated approval is to get treatments to market quickly that can be the standard of care.
Car-T was still being hand made and probably still is being hand made at huge expense when it was approved.
I believe their focus is to get this accelerated globally for approval, and to have established technology and capability that enhance the value of the company to do a deal that would accelerate things further.
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