Ok so is some punk at Citi trying to create panic by floating a pull it off market opinion going to end up right or is Jefferies that says they met with company and says it's all overblown and nothing to indicate pulling product off market going to be correct. If citi punk gets it right then you have to question did STJ management lie to Jefferies or did Jefferies lie? Tend to believe it's all overblown because the FDA inspections had to do with the plant, not the product.
The honest answer is nobody knows yet because there are still many open ended questions about Durata. Questions like:
- The St Jude product performance report is now listing Durata failures, the same failures Riata is now known for. Is this the tip of the iceberg?
- The biomedical journal that ran the study that elastion (optim) experiences hydrolysis over time and the polymer molecular weight is cut in half at 6 years. This isnt a good thing. Is it a terrible thing? It is a new thing in this whole discussion.
- St Jude tried to hide that the FDA quality concerns were on the Durata. What else is St Jude hiding?
Neither Citi, Jeffries, or St Jude know the answer yet. St Jude wants you to know their "3rd party data" show Durata is fine in their registry of over 10,000 leads. But the registries are passive, they dont look for any of the known failure mechanism, and only 12% of the leads in those registries have been implanted more than 4 years. Review the Riata 6 year data from AHA. Very scarry stuff! So, who is right? People are just making bets right now...