Actually I don't believe that was completely accurate. It was probably a partial truth. The FDA probably advised against doing another single arm open label trial until they had demonstrated a "validated" potency assay. The best method of validating the potency assay would be a successful randomised controlled clinical trial. But that's what SI hs been fighting for 3yeara and spent hundreds of millions of investor's funds to avoid doing. Let's imagine how it would look if the company finally conceded the point and actually did a randomised trial similar to the previous ones under Osiris. It would be an open admission of bad judgement and poor management. In any other company it would lead to a vote of no confidence in management and a board spill. It might well affect the conduct of the outstanding class actions. But first the company needs to secure funding to survive.
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