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Biotech / Medical : Momenta Pharmaceuticals Inc.
MNTA 52.480.0%Oct 2 5:00 PM EST
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To: IRWIN JAMES FRANKEL who wrote (2451)8/27/2010 7:15:45 PM
From: Biotech Jim  Read Replies (1) of 3027
 
<Showing sameness with biochemical analytical lab tools won't be enough to satisfy the FDA in this case, they need to show bioequivalence and this will require clinical studies, imo.>

In my opinion this could very well be the case. All because of the proposed and likely mechanism of action, induced antibody response and then crossover of reactivity to the relevant in vivo antigens causative for and associated with demyelination. Cellular immunity involved as well.

If clinical studies is a likely need, I am sure that Dew has heard, read and asked enuf of management to have had them directly respond to the question. There is always the possibility that the FDA changes or changed their view on this.

BJ
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