“The FDA has now requested additional information, which would include clinical data, for them to agree on the Study’s revised endpoints. The Company plans to go over with the FDA the overall development plan for Bucillamine in COVID-19 and further review the Pre-Dose selection data that would support the appropriate endpoints.”
Are they going to provide the FDA with what they are looking for now?
Would you prefer the words denied instead of turned down? They asked for endpoint change with two different endpoints and both times were told no those won’t work. Open your eyes.