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Thanks, WeirdPro! My only points are that there is tremendous interest
by the FDA, FDA advisory committee, and the ALS community to see this process through to approval.
The issue is additional supporting data that will convince the FDA that the 1200 trial
was, in fact, the "correct" trial and that the poor results of the 1202 trial happened
through some bias or chance. Point 2: it's up to CEPH management to get their
act together and work with the FDA. I sincerely hope they can do this for the patients' sake.
Yes, I've had to wade through some fairly impressive garbage to get there! BTW, I've never
had any position, long or short, in any CEPH security. Rudy |
