Mylan sounds frustrated this time...still has a TAD.
Comments from Q2 17 call
Let me now talk about generic Copaxone and generic Advair. Regarding Copaxone, we are disappointed with the execution by FDA of this complex ANDA, as the administrative timeline continues to move despite a number of interactions as well as meeting all of the criteria as for the product-specific guidance issued by FDA. Having said that, we strongly believe in our science and have no pending scientific questions or any additional studies required at this time and are looking forward to this long-pending approval....
...Okay, Ronny, I'll take your question on Copaxone. And as I talked about, having met all the possible – in this case we have specific product guidance out which we have delivered from the sameness perspective. And I've cited out administrative delays, and it's truly there's no science we are dealing with anymore. There are not any pending studies which FDA has asked from us or something like that. So it's perplexing because somewhere this whole reorganization within FDA that's coming into play, and we see this playing on complex and niche products, which are in this bracket. Having said that, as I told you, we remain very confident. We see no issue of bringing it to market, and it's a timing issue and that's what we are trying to adjust.
Yeah, on Copaxone, you are right about the target action date. But first of all, let me say that issues or questions, both 20-milligram and 40-milligram are the same. There is no different issue between 20-milligram and 40-milligram.
Second, why we didn't do – when I talked about the lack of predictability, yes, we have still a target action date, one target action date with us for mid- (57:20). And I didn't put it out there because we just need to get to a place with the FDA and have a better understanding rather than give you another date. And that's why, just through an abundance of caution, we have moved it and said okay, let's just move it and defer it to 2018.
