Agree totally with 1801 when consider the following from the announcement April 2022
28 April 2022
FDA grants BTX 1801 new Qualified Infectious Disease ProductDesignation StatusKey highlights
• The US FDA has granted Botanix new Qualified Infectious Disease Product (QIDP) designation for its investigational antibacterial product, BTX 1801
• New QIDP status applies to the use of BTX 1801 to potentially “reduce the risk of Staph. aureus bloodstream infections in colonized patients dependent on central venous catheters-forhemodialysis”
• QIDP status entitles BTX 1801 to receive an additional 5 years of valuable FDA exclusivity in addition to exclusivity associated with drug approval, and provides eligibility for ‘fast-track status’ and ‘priority FDA review’
• With the recent completion of additional animal studies, the Phase 2 clinical study for BTX 1801remains on track to initiate in 2Q 2022Philadelphia PA and Phoenix AZ, 28
Cheers
Agree totally with 1801 when consider the following from the...
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