No, the FDA will not allow us to move forward without a placebo, for two reasons:
1) That isn't how it is done. Trial design is complex stuff, and placebos, blinded trials, etc all play a vital role ensuring that the drug is effective.
2) Along those lines, the P2 data only has 25 participants so any data regarding efficacy can be easily skewed. Think of it this way. If I went to a carnival and took 12 friends and let them play the game where the goal is to shoot a basket through a hoop, and all 12 made the shot (as improbable as that may be), would it be fair to say that the carnival game is not rigged? Suppose those 12 friends were members of the 1992 USA Olympic Dream Team basketball squad.
If, however, I brought the USA Dream Team and 500 other friends, and the 12 basketball players all made their shots but only 10 of the other 500 friends made theirs...the data would show a totally different picture about the fairness of the game being played.
Simply put: sample size matters, and our safety P2A sample is too small to not move forward without conducting a larger, blinded trial with a placebo.
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