(Total Views: 1034)
Posted On: 06/28/2020 7:08:38 AM
Post# of 149715
Can anyone imagine what happens if CYDY announces no one died on leron in the severe/critical trial after 30 days? OMG...massive volume...
And good news has to be coming if inhaled nitric oxide can get emergency auth from the FDA like these guys did (text below). And they have to build these machines and then get them on the supply train.
The CYDY supply train is loaded and coming around the corner into the station now.
<<Bellerophon Therapeutics Announces FDA Clears Initiation of Phase 3 Study for INOpulse® Inhaled Nitric Oxide Therapy to Treat COVID-19
Published: May 11, 2020
WARREN, N.J. (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary and infectious lung diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application, allowing the Company to initiate a Phase 3 study of INOpulse® inhaled nitric oxide (iNO) therapy in up to 500 patients infected with COVID-19.
The IND acceptance follows agreement by the FDA earlier this year to allow investigational treatment with INOpulse for COVID-19 patients under emergency expanded access. To date, over 50 patients with COVID-19 have received treatment with INOpulse under the care and supervision of their physicians.
“The acceptance of our Phase 3 study for the treatment of patients infected with COVID-19 represents a major advancement in our clinical development program and enables us to gather the required clinical data for potential regulatory approval of INOpulse for patients with COVID-19,” said Fabian Tenenbaum, Chief Executive Officer at Bellerophon Therapeutics. “Under the emergency expanded access program, we have been encouraged by the improvements in patients with COVID-19 treated with INOpulse, reinforcing the potential for our propriety therapy to improve oxygenation in patients and halt the progression of the virus. We look forward to working with institutions across the United States to enroll patients into this important clinical trial and accelerate access to patients in need.”
(1)
(0)
Scroll down for more posts ▼