Innovation Pharmaceuticals Inc (IPIX)

[centillion]

Re-post of Basil22's post on 08/21 #319619 - Could it be relative?

This is the response I received from the FDA after informing them of Brilacidin.
I hope other IPIX longs use the information below to contact the FDA as well.
Go Brilacidin!!

Thank you for writing to the FDA. This is in response to your email dated June 28, 2020, to Dr. Stephen Hahn, Commissioner, concerning research being conducted on a treatment for COVID-19. Dr. Hahn has requested that your email be forwarded to the Division of Drug Information in FDA’s Center for Drug Evaluation and Research (CDER) for a response. Due to the number of COVID-19 related inquires we have received, we apologize for the delay in responding.

We appreciate the time you have taken to bring this research to our attention. CDER is committed to supporting the development of novel drugs, and the potential repurposing of existing therapies, to address the Coronavirus Disease 2019 (COVID-19) public health emergency. The Office of New Drugs (OND) within CDER is expediting this effort, working with potential drug sponsors to rapidly move products into clinical trials, while assuring that the trials are properly designed and are appropriately safe.

Given the urgent nature of the pandemic and the number of companies and researchers developing COVID-19 related therapies, FDA has created a special emergency program for possible therapies called the Coronavirus Treatment Acceleration Program (CTAP). This program uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. We continue to support clinical trials that are testing new treatments for COVID so that we gain valuable knowledge about their safety and effectiveness. Sponsors of CDER-regulated drugs can find information on drug development programs and request feedback through the links on this webpage.

Information about a drug that is not approved, is confidential according to 21 CFR 314.430, and belongs to the manufacturer/sponsor developing the drug, so we cannot provide information about drugs not yet approved to the public. We understand how important it is however for the public to have access to new drug approval information for their treatment needs. When a new drug is approved, this information will be posted to our Drugs@FDA site within 24 hours.

You can also subscribe to our free email listserv to receive the latest updates to our site including approvals of drug product applications.

If you have drug related questions or concerns in the future you can call us at 301-796-3400 or [phone] (toll free), e-mail us at [e-mail] or write to us at:

Food and Drug Administration
Division of Drug Information
Hillandale Building
10001 New Hampshire Ave
Silver Spring, MD 20993-0002

We hope this information has been helpful.

Best regards,

Lesley R. Navin RN, MSN
Drug Information Specialist
Division of Drug Information | Center for Drug Evaluation and Research
Food and Drug Administration