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WeirdPro, I don't believe that Myo will be dumped. There's just too much interest in the drug
by the FDA, the FDA advisory committee, physicians who treat ALS patients, and of course patients
themselves. I believe it's likely that CEPH will run a combo trial of Myo+Rilutek vs. Myo or
a trial of Myo vs. placebo in exchange for approval. Also, it is possible
to collect supporting data from the treatment IND program as suggested by
the FDA advisory committee. And don't forget the ongoing Phase III trial of Myo (very similar to the
study #1200 protocol) being run in Japan by a CEPH liscensee. Data from this study
is expected in about two years. Before positive things can happen, however, CEPH management performance (which
has been extraordinarily poor) has to improve. They need to drop their
arrogant, confrontational attitude and learn to work *with* the FDA instead of completely
disregarding FDA directions. Better yet, CEPH's board would do well by
wholesale replacement of the management team. Rudy |
