NeuroSense Therapeutics Ltd (NRSN)

[stockforce]

In this October's conference call, the company was asked the possibility of getting FDA approval right after Phase 2b results.
Q: Amylyx ($AMLX) received FDA approval for their combination therapy after a single phase two study (for ALS). So do you believe you'll be able to do the same for Prime C?

A: It's really entirely based on the readout of the phase 2B study. We're going to be in close connection with regulators and if the results are compelling we'll discuss this pathway forward with them (FDA), but ultimately it will be dependent on the readout.

Q: Can you predict how how early could Prime C be on the market?

A: Due to the dynamic regulatory environment and based on these decisions by the FDA for Amylyx and Biogen's therapies over the last 12 months, if we have outstanding data from the phase 2B study, it could be after we have data from this study we could move forward and have Regulators approve Prime C.

Watch the video starting at 18'43"

https://www.youtube.com/watch?v=ZLL_QdiepMo