My comment about 'FDA is not an issue' perhaps needs further...

My comment about 'FDA is not an issue' perhaps needs further clarification- my comment is trying to say that FDA approval is a case of WHEN not IF. The two synthetic analogues that the company has produced is revolutionary in this field. Their mode of action is easily understood and the improvement in the lives of these children is well documented. Perhaps you could tell me where in the FDA approval process do you feel trofinetide and the clinical results may produce delays in approval. I agree that FDA is the most important event but if you look at the research team behind it, the results produced to date and the mode of action behind these pharmaceuticals then this last hurdle that requires clearing is a low one.