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MI Dendream

04/16/22 8:23 AM

#460069 RE: biosectinvestor #460056

The study design receiving approval to move forward does not mean that the Statistical Analysis Plan has been agreed to, and even then as you know Biosect, no study and SAP truly gets fully approved until FDA has data in hand, plays with it themselves and they sign off on the results.

Even an SPA is non-binding