Biotech Values

[zipjet]

40mg of Copaxone dosed thrice weekly will almost certainly be efficacious, but it may not be as safe as ordinary daily Copaxone dosed at 20mg. Hence, the FDA will almost certainly not entertain an NDA for thrice-weekly Copaxone until all of the safety data are in hand, and this means a submission in late 2014 at the earliest.

The biggest problem with Copaxone - the problem most patients live with is site injury. Rotating the site is essential and not too difficult.

Now consider delivering twice the size of the physical dose to a given site. Will that exacerbate the issue? Or consider doubling the concentration of the dose. Will that make the problem worse? This is clearly ONE of the issues the studies need to look at.

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