Petros Pharmaceuticals, Inc. (PTPI) stock plummeted 6.02% in the pre-market trading session at the price of $1.25 after reporting positive data of its OTC label comprehension study.
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PTPI has dedicated to evolving as a leading specialized healthcare company for men. The firm identifies, acquires, develops, and commercializes novel therapeutics to treat men’s health problems, including Peyronie’s disease, hormonal health, and substance abuse.
PTPI OTC Study Positive Results
On 19th April 2022, PTPI published positive data from its over-the-counter label comprehension clinical study evaluating STENDRA (avanafil). These results propose that the draft drug’s facts labeling language as written will be appropriate for FDA submission for OTC labeling review. The pivotal study assembled over 453 label comprehension interviews to understand drug facts labeling for STENDRA.
According to the study parameters, the proposed OTC labeling remained well understood by those clients who participated. Above 95% of candidates provided acceptable answers to queries that evaluated understanding of nine basic communicative messages. Interestingly, the participants with lower health literacy also demonstrated a high level of comprehension.
PTPI Market Outlook
PTPI stock is working with the U.S. FDA to acquire an over-the-counter rank for its lead product candidate, STENDRA. Achieving OTC status will drastically extend the company’s STENDRA market by boosting access to the solution for sexual disorders. In December 2021, the stock reported positive data for its OTC label comprehension study evaluating STENDRA. Later in January 2022, the company launched two self-evaluation studies for STENDRA.
Along with the FDA approval of STENDRA for OTC status, PTPI is also enhancing the efficiencies of its business to maintain progress while reducing its corporate expenses. The stock ended 2021 with cash of roughly US$24M, which will help to execute its business projects. Meanwhile, it has reduced net loss by roughly US$3.6M during the year 2021.