>> They further claim that their particular TR mechanism reduces that variance, so that there is a more predictable correlation between dose and blood level across subjects. <<
And what claim did they lend to Biovail??
:-)
I don't trust them. However, that's irrelevant apart from seeking this reassurance..... do we know that the bicifadine formulation in the dental pain phase III is the TR one?? They've conducted phase II trials with and without TR, and the phase III PR mentions only that....
DOV conducts a joint venture partnership with Elan Corporation plc (NYSE:ELN) to develop controlled release formulations of bicifadine for the treatment of pain.
While the phase II PR said that.......
Five earlier double blind, placebo controlled Phase II studies of bicifadine used an immediate release formulation and demonstrated statistically significant pain reduction comparable to or greater than positive controls such as codeine. The current Phase II study using a controlled release formulation has achieved an important milestone in the development of bicifadine,” said Dr. Bernard Beer, president of DOV.
Is this a "phase III", or a "phase III"? That is, is this another in a long string of in vivo experiments, or is this a trial that is truly designed to assess the molecule in a formulation that the company can (or will) MARKET?
Harry...... you do this frequently, dropping in to lend much-needed clarity. Thanks, very much, for the discussion. |
