It's unrealistic to think that everything can be primed and ready to go, just waiting for FDA approval @bigb888.
There is a shortlist of candidates, but both parties must be prudent. The candidates are proposing to spend millions of dollars of company money in prepayments, regulatory compliance costs, launch resources (including staff), and communicating with local Retts Syndrome support groups (and other stakeholders) to identify potential patients. All these items need to be included in the contractual documents, and approved by the relevant decision makers.
There are so many moving parts that it simply can't be pulled together in 5 minutes. It is only now with FDA approval, that tentative plans can be finalised, approved, and presented to NEU for consideration.
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