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floblu14

12/10/10 9:17 AM

#110631 RE: DewDiligence #110628

Furthermore -

Dr. Kozlowski: So, to follow up, that assumes that you can characterize anything of importance.

Dr. Roach: I don't know that I want to be so bold as to make that statement here today, but what I will say is that our technology platform, and I'm sure other people that are working on this, bring a whole other degree of resolution to these compounds.
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oldberkeley

12/10/10 9:18 AM

#110632 RE: DewDiligence #110628

Dew- I think that the last sentence-or-two exchange between Behrman and Roach actually gets to the nub of the entire issue.

Do you feel that some day interchangeability can be established without any clinical data?
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ThomasS

12/10/10 6:59 PM

#110687 RE: DewDiligence #110628

MNTA: Dr. Roach: ...So that, by the time you get to drug product through these learnings, you may, in fact, have a drug product that may be more similar to the reference product that the differences you observed between lot-to-lot in the reference product.

I think this says it all irt MNTA's Copaxone aNDA confidence level, IMO.
It's no wonder Teva is on CP #3, due to worry.