These PIs are a group of genetic disorders. 2019 using a process known as fractionation. Commercial sales of ASCENIV commenced in October of 2019. The safety profile of ASCENIV is comparable to that of other immunoglobulins. The mean fold change for placebo treated patients was 1.42 (95% CI 0.64, 3.17). These purification processes have the potential to reduce the viral load. 183;Certain Phase III clinical trials are referred to as pivotal trials. The FDA and the sponsor must reach agreement on the PSP. Such post-approval studies are typically referred to as Phase IV studies. Coverage policies and third-party reimbursement rates may change at any time. The Florida telephone number is (561) 989-5800. Such filings are also available to the public on the SEC\'s website at www.sec.gov. 183;Our auditor's report contains a going concern statement. &# These losses are expected to continue for an extended period of time. We may not be able to generate these revenues or achieve profitability in the future. FDA's guidance is continually evolving. The COVID-19 pandemic may also result in changes in laws and regulations. The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change. If we are unable to successfully manage our growth, our business may be harmed. Furthermore, if such activities are prohibited, it may harm demand for our products. These fees may adversely affect our future financial prospects and performance. Many of these factors are beyond our control. As a result, an investor might find it more difficult to dispose of our common stock.
