Unidentified Investor's questions to Scinai Immunotherapeutics Ltd (SCNI) leadership • Q2 2024
Question
An unidentified investor inquired about the company's regulatory strategy and how it plans to accelerate development timelines and reduce costs.
Answer
CEO Amir Reichman highlighted Scinai's strategy of working with top regulatory advisors to justify accelerated pathways. He gave two key examples: gaining approval for a combined Phase I/IIa trial directly in patients, bypassing a separate healthy volunteer stage, and securing permission to use pigs for toxicology studies instead of more costly and time-consuming non-human primates (NHPs). These strategic moves significantly shorten the time to market and lower development expenses.