Replies to post #345335 on Innovation Pharmaceuticals Inc (IPIX)

[Here Today]

They were Granted the Fast Track by the FDA for Brilacidin’s use as a Covid-19 Therapeutic. They don’t hand them out too often. If they did, you would have seen more than the handful that were granted Fast Track for Covid-19 study. And one of those drugs that received Fast Track was Remdesivir. So you tell me if that helped Gilead receive the EUA??? Here is some facts from the below link:



https://www.fda.gov/media/137574/download




On March 26, 2020, FDA granted Fast Track designation to Gilead for Veklury, which among other things, maximizes the opportunities for Gilead to engage with the Agency on its development of Veklury, for the treatment of COVID-19.



Q. What did FDA do to facilitate the development and expedite the review of Veklury?
A. On March 26, 2020, FDA granted Fast Track designation to Gilead for Veklury, which among other things, maximizes the opportunities for Gilead to engage with the Agency on its development of Veklury, for the treatment of COVID-19.
Based on this designation, on April 6, 2020, FDA granted Gilead’s request and accepted its proposal to allow for a rolling review of its development program for Veklury. Under this process, Gilead could submit and FDA reviewed sections of Gilead’s New Drug Application (NDA) for Veklury as they arrived. Under traditional processes, FDA’s review of an NDA does not begin until the sponsor has submitted the entire application to the Agency.
In August 2020, Gilead announced publicly the submission of their New Drug Application (NDA) for Veklury for the treatment of COVID-19. See https://www.gilead.com/news-and-press/press-room/press- releases/2020/8/gilead-submits-new-drug-application-to-us-food-and-drug-administration-for-veklury- remdesivir-for-the-treatment-of-covid19
On October 22, 2020, 76 days after receiving Gilead’s NDA for Veklury, FDA approved the drug Veklury for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.

Just my opinion.

[Jhawker]

Did you see the peer reviewed article?