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Re: biosectinvestor post# 293511

Friday, 07/03/2020 7:29:27 PM

Friday, July 03, 2020 7:29:27 PM

Post# of 704418
They are not supposed to know, correct. Blinds are rarely perfect. The FDA understands in cellular therapy trials, it’s much harder to have a perfect blind. Add to that a crossover, and the difficulty maintaining a perfect blind is understood to be quite difficult. That said, Les and DI would be the least likely to have any inkling regarding what regulators and the CRO were grappling with. Maintaining the blind to the extent possible would have been paramount. However, if randomization ceased at 300 enrolled for ethical reasons, the preservation of a perfect blind would be even more difficult, but the fact that the public is still in the dark is a good sign. Most blinds are not perfect, and the regulators know this. It could be one reason they went out to five years is because that took away the potential to time earlier locks to fit any curve separation sweet spots from anyone’s hands.

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