Using a Rocky reference, we have gone through the training. The fight has started. We have taken a beating. But, to the surprise of everyone, we are still standing. Now is not the time to throw in the towel. Buckle down and keep plugging.
We have all the elements to run a trial, be it a quick 1, or a more involved 2B. So, development time isn’t a problem. Did we forget a test? Ok, we run another test. Maybe a couple months for results. Or, does the FDA need extra time to understand the process? COVID is a priority. Maybe they need extra time to understand our small company’s project during this hectic time.
Sorry, I don’t know for sure but, we are still standing, any that surprises a lot of people. (Cue Rocky music)