Thursday, October 27, 2016 2:08:23 PM
Enter Elite!!
Lack of proper research & development to submit an approvable NDA.
Apparently the lack of disclosure regarding Tmax on Elites alleged BE study and in spite of the Avridi catastrophe for similar Tmax issues, Elite submitted a sure to fail NDA anyway..
This wasnt a mistake! This was recklessness at a minimum imo (being tender here) for lack of development & commitment of resources to an IR ADF which could deliver with an acceptable Tmax delay. Instead they either cut corners or filed it anyway for the benefit of raising capital at high valuations while the dream of a Sequest FDA approval was floating in investors heads
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