RE:RE:RE:RE:RE:Theralase Technology Demonstrates High Kill Rate of Coronavi
Spam but noteworthy on the covid therapeutics scene (CYDY):
Something is very obvious
1. We are very thankful the FDA is allowing severe-to-critical COVID-19 patients access to Vyrologix™ (leronlimab) again under eIND while we await the unblinding of data from our recently completed Phase 3 registrational trial. We are receiving daily requests from families seeking our drug for a loved one with COVID-19. In recent months, leronlimab received more than 60 eIND authorizations from the FDA, and during the pendency of our COVID-19 trials, we deferred seeking authorizations for eINDs in order to accelerate the pace of enrollment. Now that enrollment has been completed, we are pleased to be able to assist once again and remain hopeful the upcoming results of our Phase 3 trial will enable leronlimab to be more readily available for severe-to-critical COVID-19 patients.”
Then the FDA two days later:
today the U.S. Food and Drug Administration (“FDA”) provided guidance to the Company to add an open-label extension to its Phase 3 trial (“CD12”) and specific criteria for the continuation of eINDs for patients meeting the inclusion/exclusion criteria of CD12.
The CD12 protocol will be amended for adding the open-label arm extension and submitted to the FDA on Monday, December 28, 2020. Upon clearance, each CD12 participating clinical trial site will have the option of enrolling additional qualified patients, with all patients receiving leronlimab. Treatment of qualified patients will continue until the trial’s data is unblinded.