TNXP .47 - refilled my half here on Friday with flipper bids below in low .40's.
Tonix held a successful End-of-Phase 2/Pre-Phase 3 meeting with the FDA in the third quarter of this year, based on positive data from its 12-week randomized, double-blind, placebo-controlled Phase 2 AtEase study. Tonix plans to begin enrolling patients into its first Phase 3 study, the HONOR study, in the first quarter of 2017 after receiving FDA agreement on the study design and interim analysis plan.
"Since TNX-102 SL is designated as a Breakthrough Therapy, we anticipate receiving FDA comments on the HONOR study protocol and proposed interim analysis plan imminently. We proposed two interim analyses for the HONOR study as part of an adaptive design, an approach recommended by the FDA to accelerate the establishment of clinical evidence of efficacy to support a Breakthrough Therapy approval," stated Gregory Sullivan, M.D., chief medical officer of Tonix.
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