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Re: rkrw post# 109432

Wednesday, 11/24/2010 7:13:39 AM

Wednesday, November 24, 2010 7:13:39 AM

Post# of 257257

Personally I think the FDA decision is more of a risk than the litigation.



Right - by an order of magnitude.

Edit -

"Sameness" may be a higher hurdle for Copaxone than Lovenox, given that the latter was a mixture and subject to substantial variance in the branded.

I suspect Copaxone is much more uniform batch to batch, and that the feed stocks are also uniform. IF I have that right, achieving sameness is likely more about getting the manufacturing process and recipe correct. So IF they can get those factors correct AND scientifically demonstrate they have achieved sameness, then MNTA has a shot on goal. (Oh no - another sports metaphor - been reading DD too long.)

ij

There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)

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