Greta,
please accept my deepest sympathy. I would blame Ceph's CEO, not the FDA, for your tragedy. The fellow knew what was required and did not give a damn. Do not tell me that the FDA needed three years to analyze the data presented in 1995 or 1996! The fact that it took that long indicates that the FDA was waiting for additional data. The FDA does not consist of a bunch of idiots; they have some of the best educated people in the business. If they requested additional data, it means that they NEEDED these data and, most likely, the data can be obtained.
Unfortunately, Ceph is managed by a blind arrogant fellow who does not give a damn about the share holders, not to mention, human lifes. Think of how many lifes could have been saved, or lived longer, if Dr. (whatever his name) accepted the FDA recommendations and started working sincerely with them. Obviously, our beloved CEO does not see it this way. It should be his way or no way. I am surprised that the board of directors, if there is any, let him do what he is doing. I think one way to expedite the drug's approval is for the CEO to leave (or be forced to leave). I hope this will happen soon, before he ruins the company completely. I believe that somebody with his mentality should not occupy such position.
Again deepest sympathy and God Bless you.
Mounir |
