<< but my anxiety level has certainly been raised about the process.>>
From the lack of discussion on the boards so far regarding the new advisory panel, I feel this is a common emotion right now.
I feel that at least this meeting will carry an entirely different theme than last year, where even though the FDA knew there were no additional phase III studies being presented since the first panel meeting of 1996, the major issue raised in opening the meeting was the FDA's "wish" to have two independent, and confirmatory phase III studies in order to approve an NDA. It was out of this theme, that the most important question, "Should myotrophin be approved for marketing" was never asked.
With the new FDA reform, the game is different and this question must be asked, especially as it was unamnimously agreed upon in the last meeting that the US study did show significance.
Meanwhile, who markets Maalox? That is the short term play for the next month. |
