Frank Brisebois's questions to Processa Pharmaceuticals (PCSA) leadership • Q1 2022
Question
Dan, on behalf of Frank Brisebois from Oppenheimer, asked if Processa is considering completing the PCS499 trial with fewer patients due to lower-than-expected prevalence and enrollment challenges, and if they plan to discuss this with the FDA.
Answer
CEO Dr. David Young confirmed they are considering a smaller sample size for the PCS499 trial. He noted the FDA has previously shown flexibility with rare disease trials facing enrollment difficulties. The viability of this approach would depend on achieving statistical significance, which would be aided by a very low response rate in the placebo group, a possibility they are hopeful for but cannot confirm until data is unblinded.