The fact that TEVA has decided to hire a former senior level FDA Scientist as their US regulatory affairs VP suggests that they are unhappy with the progress on their reviews at the FDA. I believe that this may be a signal that they feel the need for more regulatory liaison capabilities in the US. This may be a direct outgrowth of their Lovenox ANDA being stuck in the mud for so long.
pollyvonwog PMed me about this a few days ago. I figured she'd go public sooner or later. Now that she has, I have to say that I really thought you were out in leftfield on this issue, but obviously I stand corrected. I have never seen the concept aired until you floated it a couple of weeks ago. I have followed -- and often owned -- MNTA since its IPO. I never caught a whiff. So to for them to say it is well known is interesting indeed.
Teva continues to expend it capital of credibility . . .
Who is the company that filed the lovenox application for only one little-used dosing form? Maybe that is the partner and Teva was not interested in that formulation?
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