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Post# of 252487
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Re: acgood post# 126771

Monday, 09/19/2011 1:28:01 PM

Monday, September 19, 2011 1:28:01 PM

Post# of 252487
http://boards.fool.com/29550708.aspx

My response that I did on the Motley Fool. Gist, this probably bodes well for generic copaxone, but is very probably catastrophic for enoxaparin absent an successful patent suit. So really, the stock is a tremendous buy on generic copaxone, and right where it probably should be for another generic enoxaparin. Since we can only invest going forward and not would be, could bes, should bes, what is the best course of investment action from this point in time is the question.

I linked to the below site that explains the Orange Book categorization and the use of the term "Thereapeutic Equivalence". From the reading of this, there does not appear to be a large gray area of what the term means, if the term is being used correctly.

http://www.uspharmacist.com/content/s/167/c/28604/

Yes, labeling discussions is ambiguous one would think, but it could refer to something more innocuous. This remains ambiguous, but I am not hanging my hat on it (although, you know, keep hope alive and all).

The good news is, I expected about a 33% hit on a generic enoxaparin approval, and so it has hit. It does nothing to the value of copaxone and the much more favorable economics therein. If just the litigation overhang would part. FDA may be starting to get in a groove on more complex generic approvals as they have now had substantial experience in this category of generic with success.

Tinker

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