So, are you thinking the 7 week trial that started as a 7 week placebo controlled study with a volunteer 12-week extension, and morphed into a 48-week extension, will read out WITHOUT ANY EXTENSION DATA?.
And, how can a 7 week placebo control study start as a phase two study, but get reclassified as a phase 3 study without consideration of the extension data?
Could it be that, with the extension study, the data becomes pivotal and phase 3? and therefore, could it be that we are waiting for the full data to read out from both the 7 week and the extension data? is that what's taking the additional time?
Is so, it could take longer than we expect, perhaps April or May'ish before we see a readout of AVATAR plus extension data.. Then the Excellence study read out would come soon after, and the time would be ripe for a NDA application on the pediatric portion, to get the voucher allowed, followed by a NDA application on the adult portion.
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