Replies to post #107414 on Biotech Values

[jq1234]

But the topic of this discussion is not a new branded drug—it’s an application to the FDA for a generic version of Lovenox. For this, merely being a safe and effective LMWH drug is not sufficient; to be approved, the drug in question must satisfy the FDA’s requirements for sameness to branded Lovenox.

Excellent point!

[genisi]

Sorry for not being clear, by "low-quality" I referred to characterization quality in terms of the sameness to the branded drug. The topic of my posts indeed is not a new branded drug—it’s an application to the FDA for a generic version of Lovenox and my points there were that I'm pretty sure Teva had characterized the generic drug using all the available techniques and I don't believe they would have submitted an ANDA without doing so or in case the drug had been found to be so different from the branded.

[jbog]

Dew,

Lupin is no stranger to the American Generic landscape. They have numerious US marketed drugs.

Why wouldn't they have brought their enox drug to the U.S. themselves?

[10nisman]

The facts will come out in due course, regardless of what MNTA does or does not say on the upcoming CC.

Dew do you have access to get on TEVA's earnings conference call? If so, it would make an excellent question.

"Great quarter and thank you for taking my question Bill. It has come to my attention that Teva's generic tLovenox is Lupenox, generic copy of Lovenox developed by ItalFarmaco and manufactured by ItalFarmacoin. Can you please confirm this is true? Thanks and excellent quarter."

10nis