By RPRX statements, the total pooled patient count for NDA submission is 1500.
At least from the PR we now know they have less than 500 from all of their trials. It is to be noted that the data released is not for UF alone, but all patients. They are less than 1/3 to the patient exposures needed for the NDA. Their representation they are still on track for a 2010 NDA is bogus.
Their timeline is always being pushed back. Why not be honest about this and admit the filing will be delayed? Are we to believe that they will have an additional 1000 patient exposures within the next year?
The overall clinical development program for Proellex includes numerous pharmacokinetic, pharmacodynamic, Phase I, Phase II, and ongoing Phase III clinical trials. These studies used doses of Proellex ranging from 3 mg up to 200 mg daily. From completed studies as well as from an ongoing large open label trial, it has been determined that the drug appears to be well tolerated.
. . .
The following data were observed in 470 women treated with Proellex through June 2009 (n values may vary slightly due to randomization):
. . .
Additionally, Repros believes that any new studies required for the approval of the 12.5 mg dose will not adversely impact anticipated timing of NDAs for Proellex.
AI
