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Botanix Pharmaceuticals (ASX:BOT) gets U.S. FDA clearance for BTX 1801 development

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Botanix Pharmaceuticals (BOT) has completed a pre-investigational new drug meeting with the U.S. Food and Drug Administration’s (FDA) Office of Infectious Diseases.

The meeting assessed the potential of initiating clinical development of the company’s BTX 1801 antimicrobial drug for preventing surgical site infections (SSIs) in the U.S.

It also enabled the company to receive feedback from the FDA on the drug development plan needed for BTX 1801 to support a Fast Track designation and New Drug Application (NDA).

Click through to read the full article on The Market Herald here.

Botanix Pharma Talks With FDA on Antibacterial Drug

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The Green Fund has published a summary of Botanix Pharmaceutical’s BTX 1801 announcement today, an update on the development pathway for our BTX 1801 antimicrobial product.

Take a look at the article here.