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07/15/13 4:48 AM

#132775 RE: DrRocker #132773

DrRocker, count the FDA out.

If they wanted to slow us down the best, fasted and most efficient way to do it was simply to say that the trial was subject of dose switching errors and could not be reconstructed completely for all patients and therefor we don't know what exactly happened. The PII would have to be redone! Majorly more delay and slow down.

I would like to see who would dispute that and even if they did they would be in trial for years against the FDA and get even more delays. Then in the end with your PIII you come again before the FDA panel.

So, now if the FDA wants they can stop us in our shoes wherever they want, whenever they want!