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Re: DewDiligence post# 105886

Friday, 10/08/2010 3:28:21 PM

Friday, October 08, 2010 3:28:21 PM

Post# of 257257
I don't see why Teva's failure to volunteer the location and identity of the manufacturer has you wondering what they are hiding. You would be less suspicious of them hiding something if they were doing the whole thing in house? How likely do you think it is that Teva is contracting commercial manufacturing of t-enox out, anyway? I would say the odds are very small, because they would want to decrease chances of trade secrets being revealed -- among other things.

Are we agreed that since this is a complex generic, a greater part of the approvability rests on the manufacturing? I could see a slight increase in the chance for screwups in contracting it out, handing off the tech to another party -- but again, we are assuming the facilities passed FDA muster, right?

So even if it were some other company making the drug, no, I don't think it affects my assessment of the drug's approvability much, if we accept that the facilities passed inspection, regardless of whose or where. I don't understand your astonishment. Please spell it out for the stupid RockRat. I'd like another good reason to wonder what they're hiding, too.

I will say that something just struck me since this thread has come up regarding my questions to Ms. Chen to ask Teva . . . I did not specify commercial manufacturing facilities. So it's possible, if Teva is being disingenuous with its answer, that Teva was referring to its R&D manufacturing facilities for t-enox, not the scaled up commercial ones. Unlikely, but possible.

Regards, RockRat

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