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Storage and Reconstitution Storage (lyophilized) : -20C or colder After reconstitution : Store at 28C and use within 30 days Solvents : Sterile bacteriostatic water (BAC water) or sterile saline Shelf Life : 24 months from production (lyophilized) Safety and Handling PT141 is supplied for laboratory research use only

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During the meeting, FDA staff scientists highlighted a general lack of quality data supporting safety and effectiveness