Claud,
I have the impression that the trials were not impressive and that a lot of massaging was done on the data, that the long long delay in filing after completing Phase III was in part because exceptional work was done to make it look acceptable to the FDA, but that it's really not acceptable. This is basically just an impression of mine and based on hearsay, not something I would have offered to the thread as a firm prediction. LOL! I hope you can distinguish between my impressions and my predictions. I have never predicted that the app would not be accepted but it is my impression that has an above average chance of occurring here.
One problem is that Vasomax isn't that effective (in the trials) and even so a lot of people were not included in the trials, removed from the trials or dropped out of the trials. There were exclusionary factors and some high drop out rates, so the results, which were not that good anyway, were pumped up during the trials by the exclusions and removals and dropouts of subjects.
The structure of the trials, for these reasons, may be unacceptable to the FDA and better designed trials may be demanded.
Also FDA may be strict, since there's already an oral medication that's effective and ALSO because that medication has had some bad press due to some deaths and other negative effects. For these reasons FDA may demand more extensive trials on Vasomax than were done.
You asked, so don't jump down my throat about my opinion. <g>
Linda |
