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Re: floblu14 post# 101072

Sunday, 08/08/2010 5:22:42 PM

Sunday, August 08, 2010 5:22:42 PM

Post# of 252300
a post showing the chemical structure of lovenox.http://store.businessmonitor.com/article/370474
Despite the IBD article, this drug seems to be a complex type of sugar not a protein.
In the end it may come down to the willingness of the FDA to say that "nearly, almost, close enough" rather than "identical" biologically is all that is needed. IMHO,the probabilities are that the FDA will not be willing to make that jump. If this ruling is indeed setting a precedent, is that the precedent the FDA wants to set, one where every similar application becomes one of how close is close enough?

Another thing to consider is that slight variability in one generic to another usually don't matter that much. If you get 5% or 10% more or less biological effect with an antibiotic it won't make much difference to the patient. That maybe less true with an anti clotting agent. This could be an extra cause of FDA concern.

I sold almost all my MNTA shortly after the good news. But now I'm thinking seriously about reentry. Past prices don't matter- is MNTA a buy at 18? Is FUD presently more powerful than optimism? It seems that the market doesn't believe that MNTA will have the only approved generic form of Lovenex. But working backwards from a price to discover the whys of that price is a bit like trying to reconstruct the recipe and cooking procedures from a piece of chocolate cake.

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