I think the SP is purposely being held back and I realize this has even less weight than that of an anonymous investor on a message board since I am long biased, but hey its the truth. The large current short position will add to the explosion upwards in share price on good news. This mechanism of SP action is more common than people think.
I don't think that the FDA will require a P3, but appreciate NP keeping investors' expectations in check by saying it will most likely be required.