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In some embodiments, the otic formulation or composition further comprises at least one viscosity modulating agent

FDA staff's own briefing document, posted publicly ahead of the meeting as part of the docket, proposes that TB-500 (free base) and TB-500 acetate not be added to the list, citing incomplete physicochemical characterization, a lack of evidence of effectiveness for wound healing (including an in-vitro fibroblast study in which TB-500 reportedly did not induce wound healing), and insufficient nonclinical and clinical safety data

Sample size calculation Based on BinShuwaish et al

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Equalising Pressure in the Vial When reconstituting, its essential to equalise the pressure in the vial