TDA, I know you take comfort in the fact that Reddy's Mexico...

TDA, I know you take comfort in the fact that Reddy's Mexico plant has no direct involvement in fondaparinux's manufacture and delivery to market.

However, as you probably understood from previous ACL threads, I'm not so confident that there aren't indirect consequences from both this plant's problems and the appalling run of fatal accidents in their Indian operations.

I think there are plenty of signals that Reddy's may have systemic and cultural issues and that must cause consternation within the FDA.

How those concerns might generally and specifically manifest themselves can only be speculative, although in the case of the plant in Mexico we do now see the FDA's public response to a specific instance of poor manufacturing practices.

Some take comfort that Reddy's still gets approvals regularly as proof that nothing could be bad. To me, that means little. It may just reflect the quantity of applications in Reddy's pipeline.

I wonder about another indicator: for each application type (oral/injected; first generic/later generic; etc), are they starting to take longer than, say, their US peers working in the generic area?