Thursday, March 11, 2010 4:58:17 PM
first off, i agree with your post about management to a certain extent. but, from my understanding on what went wrong, technically, no "rules" were broken, the nda should have passed. there is nothing in the fda guidlines that say the 12 months of samples has to come from the same mfg. company, the fda just "likes" it to be all from the same company. and that the fda was in the process of making it a rule, but hasnt implemented it. (well, obviously they are practicing the implementation of it :)
what do you think? Please correct me if i misunderstood the PR.
thanks,
-X
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