Atossa Therapeutics requests a Type C meeting with the FDA to discuss an accelerated development strategy for low-dose (Z)-Endoxifen in breast cancer risk reduction.
The company aims to align on requirements for a New Drug Application (NDA) to potentially shorten approval timelines and reduce clinical trial costs.
Atossa has significant cash reserves and no debt, providing a strong financial position for its development initiatives.
Accelerating Development Strategy
Atossa seeks to expedite the regulatory process for (Z)-Endoxifen in breast cancer risk reduction through a Type C meeting with the FDA.
Market Opportunity
Potential market includes millions of women in the U.S. using endocrine therapy for adjuvant treatment and risk reduction, presenting a substantial opportunity for (Z)-Endoxifen.
Clinical Advantages of (Z)-Endoxifen
Improved pharmacokinetics and faster achievement of therapeutic levels compared to tamoxifen, highlighting the potential of (Z)-Endoxifen in breast cancer treatment.
- A successful Type C meeting outcome could significantly reduce approval timelines and clinical trial costs for Atossa's (Z)-Endoxifen development program.
- The market potential for (Z)-Endoxifen in breast cancer risk reduction is substantial, with a large number of women currently utilizing endocrine therapies.
Atossa's proactive regulatory strategy and favorable financial position position the company well for advancing (Z)-Endoxifen in breast cancer risk reduction, offering promising prospects for future growth and innovation in the field of breast cancer treatment.