According to Bill Marth on today’s MS webcast, after feedback from the FDA, Teva decided to conduct a new clinical trial for low-volume Copaxone rather than shelving the program. However, insofar as the FDA’s CRL was issued nine months ago and the new trial has not yet started, this program is not exactly on the express track.
For reasons that have been mentioned previously, I consider Teva’s low-volume formulation of Copaxone a gimmick that will not have any commercial consequence for MNTA. Of somewhat greater concern for MNTA is Teva’s thrice-weekly Copaxone program (#msg-63817727).
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