Technically the original plan was to dose the first patient by the end of last year. Obviously that was delayed but it has not been a full quarter. I don't know how the entire process works when dealing with FDA holds but the company submitted their trial design, which I know they spent a lot of time and resources designing, and the FDA reviewed it and had further questions. That's really not the company's fault. They responded and from what it looks like the FDA needed more clarification and that's where we are right now. You can point to management all you want, which is easy and pretty much everyone's go to when they don't understand or even try to understand what's going on, but this looks more to me like inefficiency in the FDA review. They aren't sitting in a room with people from the FDA having a back and forth dialogue about the trial design. To my understanding it's all written communication with the FDA getting 30 days to review and if anything needs to be addressed obviously the company needs time to formulate their response as well. If the FDA doesn't just immediately approve the trial design then technically the initial wait could be 60 days or more. Any other additional questions just cause further delays but unfortunately that happens sometimes. You can blame management all you want but unless they are completely ignoring the FDA comments then they are obviously doing all they can to get the trial up and running. If management is just sitting on their hands for no reason then, yes, someone should fall on the sword. Otherwise, I have to assume they are following procedure in their responses and it's unfortunately just a waiting game while the FDA completes their review.
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