It is my understanding that the end-of-phase 2 meeting has not taken place yet. It has been rescheduled after the FDA requested additional data last week.
"In communication with the FDA last week, Cellceutix was encouraged to submit additional information from the Phase 2b study, including analyses of the recently obtained pharmacokinetic (PK) data. The Company has requested its vendors to assist in preparation of this information for submission as soon as possible. Thereafter, the Company will meet with the FDA to discuss the completed Phase 2b study and to discuss the plans for Phase 3 studies."
Had the meeting been taken place, Leo will say something like this:
"FDA noted at the end-of-Phase 1 meeting on December 8, 2014 that, pending the full review of the Phase 1 data, long-term safety data for Prurisol in the treatment of psoriasis would not be required."
I'm not sure what the details from the FDA meeting(s) were and what they are looking for... I wasn't there.
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