"The FDA's constructive feedback validates our development path and brings us one step closer to providing a faster-acting intervention for heart attack patients," said Kraig Higginson, Interim CEO of Aspire. "Aligning with the Agency on our clinical requirements significantly de-risks our timeline and we believe the FDA's response leaves the door open for Aspire to obtain breakthrough therapy status for our OTASA product. We believe OTASA has the potential to become the market-leading emergency treatment, and this regulatory clarity is a vital milestone as we engage in active discussions with potential commercial partners."
[https://finance.yahoo.com/news/aspire-biopharma-announces-successful-pre-130000903.html?guccounter=](https://finance.yahoo.com/news/aspire-biopharma-announces-successful-pre-130000903.html?guccounter=)