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The company's flexible business model allows a drug to be compounded or developed as an FDA-approved product through one of its subsidiaries or spin-out companies. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Any statements in this release that are not historical facts may be considered such "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein.
While statistics can be spun to make almost anything look good, I've tried to report just the basic facts.Imprimis's MKO Melt is a compounded formulation and not FDA-approved.Other than drugs compounded at a registered outsourcing facility, all Imprimis compounded formulations require a prescription for an individually identified patient consistent with federal and state laws.We have found that it offers unique benefits to patients who may not be well suited for traditional IV sedation.I am pleased it is now protected by this newly issued patent, and potentially, other procedural sedation patent applications that remain pending."Imprimis believes that beyond cataract surgery, there are likely more than 100 million annual procedures in the US ranging from dental, obstetric and gynecological, medical imaging procedures (such as MRIs and CAT scans), vasectomies, colonoscopies, dermatological, plastics procedures, orthopedic, otolaryngological, podiatry, emergency room, urology, and psychiatric that may benefit from an IV-free and opioid-free formulation.