My attitude is not to give them benefit of doubt in this type of situation (apply to all of my pharma/biotech investment). They have to prove their case to me. Teva hasn't done that.
I believe sentiment in general is shifting now on MNTA's stock price and this shift will be further cemented with the earnings release on Monday.
It seems to be moving from: tLovenox is coming, MNTA's share price is suppressed until proven otherwise (FDA rejection which might not be divulged) -to- tLovenox is not coming, MNTA's share price runs until proven otherwise (FDA approval or information indicating progress towards tLovenox approval)
Also keep in mind Teva's ANDA was submitted 7 years ago...
back then, i suspect, the FDA did not provide 'specific' guidance on what was required for approval.
today we know... 1. If a manufacturer wants to make a generic enoxaparin sodium, it has to design a manufacturing process that is capable of reproducing these distinct features of the drug.
2. Demonstration of “sameness” for enoxaparin sodium requires “state-of-the-art” analytical methods to show that the structural features of oligosaccharides in the generic enoxaparin sodium are equivalent to those in Lovenox.
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