LNCs have been delivered orally, intramuscularly, intravenously and through inhalation. 9679; Enabling an all-oral therapy. None of the AEs were related to abnormal laboratory evaluations. The cohort receiving 1.5 g had 7 clinical AEs in 1 subject. Ten participants were randomized to the experimental arm and 4 to the control arm. The read-out for Cohort 2 is expected in the second half of 2021. Therefore, more specific and active and less toxic antimicrobials are urgently needed. Adverse events were tolerable and not unexpected. Statistical significance as achieved in the PP population (20.9% vs. 13.8%). &# These patents provide important protection to LYPDISO through 2033. Approval of Vazkepa is expected in the second quarter of 2021. Final results were published in November of 2020. These fees are typically increased annually. FDA may request additional information rather than accept an NDA for filing. 9679; We will need substantial additional funding. 9679; We are early in our development efforts, which may not be successful. &# As such, the application of accounting guidance for such items is currently uncertain. At present, we have no sales or marketing personnel. We may not be able to enter into such agreements on terms acceptable to us or at all. Similar requirements exist in many of these areas in other countries. We are in the process of evaluating potential next steps in the development of LYPDISO. 61 LYPDISO is designed to be a prescription-only omega-3 fatty acid-based medication. However, we cannot be sure that physicians or consumers will view LYPDISO as superior. However, trade secrets are difficult to protect. 68 A reverse-stock split of our common stock may not have the intended consequences.
