Elite Pharmaceuticals Inc (ELTP)

[dr_lowenstein]

It is very common for a BE/Tmax trial of this large size to experience drop outs.

All 45 patients must meet the Inclusion/Exclusion criteria (1)at the beginning of the trial (2) during the trial and (3)at the end of the trial.

For those patients that have been disqualified their statistical data have been discarded by the FDA.

comment: yes a drop out or two is common, but not to the extent that occurred here. Incompetence.

Further, the FDA has not even seen the data yet, so it is completely inaccurate to claim that they have and they have discarded the data