Replies to post #111012 on Biotech Values

[exwannabe]

Tinker, Am I mistaken? If a clinical trial was required for generic copaxone, wouldn't the FDA just be looking for safety profile. If so, wouldn't they be able to show safety with a smaller group in a year or so?

I believe that by law the FDA can not request a trial for safety/efficacy on an ANDA.

That is actually the basis of the SA suit against the FDA on mL, they are claiming that the immune. data request is actually a safety trial and thus is against the law (and subsequently makes the FDA's use of SA data illegal).