| |
Hank:
I for one appreciate your comments. As a former drug development professional, I concur with the sentiments you expressed concerning comparative efficacy and the approval process.
As I am sure you have experienced, for products FDA does not think are as clinically useful as those of competitors, instead of rejecting the compound outright, sometimes they will bury the product by asking for more and more information, additional studies, etc. Then, five years from now, with enough data versus conventional treatment, the product may see the light of day and an abbreviated label. I am not saying this will happen with Vasomax, but if it did, I would not be surprised, especially now that fast track is unlikely.
FJA |
|
