Let me explain something, I guess some people have

Let me explain something, I guess some people have not figured out. Pro 140 was going to get approved with a single 50 patient trial. The FDA had requested 30, but then moved it 50. Then in 2017, the FDA still wasn't satisfied, they wanted 100, possible another trial. Over 50% of approved drugs have two phase 3 trials. IZ had two phase 3 trials and some phase 2 trials. Pro 140 has just ONE p2b/3 trial for combo, not even a full phase 3. Instead of completing another p3 trial, they agreed to get data from the mono investigatory trial. Unfortunately the mono trial was not complete. This is causing all the delays for the BLA, the mono trial was a work in progress, with changes to dosing. If they had just went to another p3 trial or extended p3 combo trail, we would still be waiting for patients to be enrolled.