On track to submit Biologics License Application (BLA) for INO-3107 in 2H25, with the goal of file acceptance by year end Completed design verification (DV) testing of CELLECTRA® 5PSP device required for BLA submission and requested rolling submission from US Food and Drug Administration...
Related Questions
What is the expected timeline for FDA acceptance of the INO-3107 BLA and how might that affect the stock in the short term?
How does the progress of the CELLECTRA® 5PSP device design verification compare to similar platforms in the industry?
What are the potential revenue implications of a successful BLA submission for INO-3107 in the second half of 2025?
How might the rolling submission strategy impact the likelihood of regulatory approval and market perception?
What are the risks if the FDA does not accept the BLA by year‑end, and how could that influence the stock volatility?
What is the market's current pricing of INOVIO's pipeline assets relative to competitors' similar products?
Could the successful BLA and device verification lead to partnership or licensing opportunities, and what would be the potential impact on valuation?
How does INOVIO's current cash runway and financing needs compare to its peers given these upcoming milestones?